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Remote Data Capture:Acquisition and AnalysiseClinical Visions
HEALTH SCIENCES
Contents:
Trends and Issues in an Electronic Clinical Data Management WorldPatti Devereux Gaves and Alastair Clewlow, Oracle Health Sciences
State-of-the-Science—The New Remote Data Capture ParadigmRobert R Goodwin, Pfizer, Inc.
Improving and Monitoring Clinical DataManagement in the eClinical AgeJames Streeter, PPD, Inc.
Optimizing and Supporting Remote Data CaptureDave Hanaman and Rob Vollkommer, C3i, Inc.
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ECLINICAL VISIONSREMOTE DATA CAPTURE:ACQUISITION AND ANALYSIS
HEALTH SCIENCES
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Trends and Issues in an Electronic Clinical Data Management World 3Patti Devereux Gaves1 and Alastair Clewlow2
1. Senior Director, Life Sciences Product Strategy; 2. Director, Product Strategy for
Clinical Data Management, Oracle Health Sciences
State-of-the-Science—The New Remote Data Capture Paradigm 6Robert R Goodwin
Vice President, Global Clinical Data Services, Pfizer, Inc.
Improving and Monitoring Clinical Data Management in the eClinical Age 9James Streeter
Executive Director, Electronic Data Capture, PPD, Inc.
Optimizing and Supporting Remote Data Capture 13Dave Hanaman1 and Rob Vollkommer2
1. Executive Vice President and Co-Founder; 2. Vice President, Clinical Services, C3i, Inc.
eClinical Visions
Introduction
Contents
ECLINICAL VISIONSREMOTE DATA CAPTURE:ACQUISITION AND ANALYSIS
© T O U C H B R I E F I N G S 2 0 0 92
08_Oracle_contents.qxp 18/5/09 12:25 pm Page 2
3© T O U C H B R I E F I N G S 2 0 0 9
Trends and Issues in an Electronic Clinical Data Management World
a report by
Patt i Devereux Gaves 1 and Alastair C lewlow 2
1. Senior Director, Life Sciences Product Strategy; 2. Director, Product Strategy for Clinical Data Management, Oracle Health Sciences
Over the last 15 years, Internet and eTechnologies have become an
integral part of everyday business in most sectors, but have taken time
to gain traction in the clinical trials arena. Now, as the industry faces
unprecedented challenges and further consolidation, companies are
increasingly embracing technology as a lever to differentiate themselves,
boost productivity, and succeed in the new environment.
The Internet, Pharma, and Electronic Data Capture
In the pharmaceutical industry, the emergence and acceptance of
Internet-enabled technologies such as electronic data capture (EDC)
have transformed clinical development practices, efficiently supporting
faster, larger, and more complex trials.
Current industry projections estimate that EDC is now used in
approximately 50% of all clinical trials (see Figure 1).1 Companies are
increasingly leveraging EDC and other tools to power global trials and
benefit from the ability to analyze incoming data and performance
metrics in real time. The availability of such data supports more rapid
decision-making and provides the agility to make necessary
adjustments during ongoing trials.
With increased adoption of EDC, market expectations for the
technology are high. A more technology-fluent user base is
demanding richer features, ease of use, and flexibility within trial
settings. Global usage also requires high availability and scalability.
Furthermore, there is a growing acknowledgement that EDC
represents only a subset of the critical aspects of the overall data value
chain, highlighting the need for a fully integrated eClinical ecosystem.
Such an integration of EDC and other eClinical systems will provide a
holistic view across trials and data sources and minimize process and
infrastructure redundancies.
In this dynamic environment, EDC and other clinical trial technologies
can deliver real fundamental benefits but also continue to introduce
new challenges as the eClinical evolution continues. Some of these
issues are discussed below.
Changing Roles for Data Management
Data management organizations in particular are front and center in
this bold new world. Due to the increasingly prevalent use of EDC
coupled with industry outsourcing trends, the role of an ‘in-house’
data manager has changed considerably. Further removed from the
daily discrepancy resolution routine, these individuals are now charged
with program-level oversight responsibilities, including tracking
progress of work being conducted by third-party contract research
organizations (CROs), and sometimes across multiple organizations on
several studies. While skills in the core data management systems are
still vital, better tools are necessary to provide oversight-level data in
real time, and productivity and performance metrics are paramount to
understanding and measuring this new environment.
Globalization and New Challenges
While ongoing global expansion of trials presents new opportunities,
it additionally increases the pressure and demands placed on EDC and
IT infrastructure and support resources. The growing prevalence of
global site users and outsourcing practices have transformed clinical
trials into an around-the-clock operation. This ‘always on’ business
model creates a technical support dilemma. Given the 24/7 availability
requirements to support the global trial environment, there is no
opportune time to schedule maintenance and perform repairs.
Trends and Issues in an Electronic Clinical Data Management World
Alastair Clewlow is Director of Product Strategy forClinical Data Management in the Oracle Health SciencesGlobal Business Unit. He has 12 years of experience in thepharmaceutical industry, beginning as a Data Manager at LEO Pharma before becoming a Clinical ResearchAssociate. Mr Clewlow relocated to Denmark in 2000 toimplement a clinical trial management system, beforebecoming Head of the Clinical Data and DocumentManagement Department, with responsibility for clinical
data management, clinical and safety systems support, and management of clinical trialdocumentation. He graduated from the University of Portsmouth with a BSc (Hons) inmolecular biology.
Patti Devereux Gaves is Senior Director of Life SciencesProduct Strategy for Oracle’s Health Sciences GlobalBusiness Unit. She returned to Oracle in June 2008 fromPfizer, where she held the positions of Senior Director,Technical Operations in Global Clinical Data Services, andDirector of Patient Data Systems in DevelopmentInformatics. She has more than 15 years of clinical datamanagement and related technology experience, andspent five years in Oracle’s clinical consulting group
leading customer implementations and delivery teams, as well as several years in datamanagement at Parke-Davis. Ms Gaves holds a BSc from Eastern Michigan University andan MA from the University of Michigan.
A more technology-fluent user base is
demanding richer features, ease of use,
and flexibility within trial settings.
Clewlow_new.qxp 12/5/09 4:16 pm Page 3
Furthermore, in the event that a technical problem that affects EDC
system availability does occur, all sites using the technology platform
can potentially be affected. For example, a pharmaceutical company
running 300 trials concurrently might, in the worst-case scenario, have
to suspend workflow on all trials until access to the system can be
restored. Given the staggering implications of this example, companies
are focusing on issues such as infrastructure/server redundancy,
backups, and failover. With EDC, there is an absolute dependency on
IT support and service levels to ensure business continuity running
clinical trials. This reality has been an internal hurdle for some
organizations seeking to implement EDC, and some organizations
have opted to outsource.
Similarly, since EDC use extends to site staff as well as CROs and
business process outsourcing providers, the exponential growth of
user populations has led many organizations to rethink their
EDC support strategies. Both end-user training and ongoing helpdesk
support is critical to success with EDC. Vendors are coming into this
space specifically to handle initial training, arrange Internet
connectivity around the world, negotiate Internet service provider
agreements, provision and track hardware when necessary, and
provide all-hours helpdesk services in multiple languages.
Trial Complexity
Trials have evolved significantly over the past several years. Historically,
the traditional trial model followed a natural, sequential pattern in
which companies would collect data over the course of the trial, and
when completed would lock the database, carry out analyses, and
assemble a candidate submission. Clinical trials today, however, are
much more complex. The advent of EDC enables much earlier data
review, and it has also helped advance new trial designs that rely on
such early data availability. Instead of a single analysis after the trial
completes, trials today require multiple sophisticated data cuts and
ongoing analyses. Availability of data from EDC helps to facilitate such
‘soft-lock’ processes, effectively simulating a subset of the traditional
end-of-study procedures with interim data.
This mid-study process can occur multiple times during the trial for
safety monitoring boards, submissions, or interim reviews. However,
utilizing this sort of rolling lock system consumes more resources than
the traditional process. So, while EDC enables resource savings for
traditional discrepancy management activities (as projected), this trend
for more complex trials and process changes introduces added
complexity and new resource demands to support a study.
The use of adaptive trials is also increasing, which requires support for
real-time insights and a variety of mid-trial modifications for dynamic
response to changing circumstances.
Complex trials are also being leveraged strategically to optimize
resources and productivity given the constrained financial climate,
budget cuts, and pressure to run fewer trial programs. To meet trial
quotas while fulfilling project needs, companies can opt to run
multiple studies within a single trial. For example, within a single
oncology trial, there may be six separate study populations each based
on a different tumor type.
4 E C L I N I C A L V I S I O N S
Trends and Issues in an Electronic Clinical Data Management World
Figure 1: US Electronic Data Capture Adoption
80
70
60
50
40
30
20
10
0
12
10
8
6
4
2
0
Perc
enta
ge o
f tria
ls u
sing
EDC Acceleration in grow
th (%)
2003 2004
New EDC trials (phase I–III)
2005 2006 2007 2008 2009 2010 2011 2012
Acceleration in growth
Source: Adapted from Health Industry Insights, 2008.1
The advent of EDC enables much
earlier data review, and it has also
helped advance new trial designs that
rely on such early data availability.
Complex trials are also being leveraged
strategically to optimize resources and
productivity given the constrained
financial climate, budget cuts, and
pressure to run fewer trial programs.
Clewlow_new.qxp 12/5/09 4:16 pm Page 4
Data Integration and Interoperability
EDC is just one aspect of the eClinical ecosystem. There are many
systems employed throughout the clinical development process for
data acquisition, data analysis, trial management, and reporting. As
the volume of data from all sources increases, the need for an
intelligent aggregate data storage environment becomes imperative.
Oracle has introduced one such system, the Life Sciences Data Hub,
that enables access to all trial data from a single location, thus greatly
reducing the time and effort required for study reporting milestones
while providing the ability to accurately track and reconstruct
complete reporting data sets and outputs.
While there are a multitude of available software platforms designed
to manage various aspects of clinical trials, most of these disparate
systems work independently of one another, unable to communicate
or share information. Additionally, sponsor companies may use
separate, independent vendors for each IT system, particularly if they
seek to employ ‘best-of-breed’ options for every product type. When
overlap does exist between applications but identical data must be
entered into them independently, the issues of redundancy and
inefficient use of both time and resources are compounded.
Going forward, interoperability will be a key factor in realizing
maximum possible results using eClinical systems, allowing records to
be linked and shared, and eventually improving efficiency and
reducing overall costs. Industry standards will evolve to make disparate
platforms interoperable and less proprietary. Oracle is working toward
this objective by developing the Health Sciences Suite platform, a fully
integrated suite of best-in-breed eClinical applications that will also be
able to extend to applications from other vendors.
The Road Ahead
The industry is changing more rapidly than ever before and
organizations across the pharmaceutical spectrum are dealing with
many of the issues discussed herein. This report features contributions
from leaders of some of the organizations working at the forefront of
the EDC movement. These authors describe their organizations’
experiences of working with Oracle’s EDC solution, Remote Data
Capture (RDC), and provide insights into related challenges, successes,
and lessons learned.
Robert Goodwin, Pfizer
As the world’s largest pharmaceutical company, the way in which Pfizer
implements and handles the running of full-scale EDC will be a
touchstone for other companies in the industry. Robert Goodwin, Vice
President of Global Clinical Data Services, talks about the role of
technology when working with many different kinds of partners,
including investigators, technology vendors, and CROs, in collaborating
to run complex, global clinical trials.
James Streeter, PPD
The CRO is now a critical link enabling pharmaceutical firms to run
large, intricate clinical trials as efficiently as possible in many locations
around the world. James Streeter, Executive Director of EDC, talks
about the pressures on a CRO to ensure that staff are properly trained
and supported to keep pace with the high-pressure, fast-moving
clinical trial environment.
Dave Hanaman and Rob Vollkommer, C3i
Technology is the enabler, but who empowers people to use it? Step
forward technology service company C3i, which works to ensure that
clinical trial staff have access to the right equipment when they require
it, have the requisite knowledge to get the most out of it, and have
support on hand for when they need it.
We extend our sincere appreciation to our contributors for sharing
their valuable insights and experiences in this report. The eClinical
transformation offers a chance to maximize the value of clinical trials,
improving pharmaceutical development efficiencies and ultimately
providing patients with timely, new, and improved treatment options.
We have seen significant progress to date and tremendous
opportunities lie ahead. Companies of all types and sizes must respond
to the pressures the industry is facing, trim operating expenses, and
establish cost-effective and efficient working practices. It is critical to
weigh technology investments against both short- and long-term
objectives. Oracle is committed to the health sciences market and is
uniquely positioned to deliver a full-spectrum, comprehensive solution.
Although there will be short-term challenges to overcome in the
process of continuously adapting to new technologies and gaining
acceptance of new ways of working, we hope that this report will
resonate with those professionals who are helping to lead the way
through the eClinical landscape toward a complete, open, and
integrated clinical trials ecosystem.
We look forward to your thoughts and feedback. ■
5E C L I N I C A L V I S I O N S
Trends and Issues in an Electronic Clinical Data Management World
1. Louie A, US Electronic Data Capture 2007–2012 Spending Forecast and Analysis, Health Industry Insights, 2008.
Going forward, interoperability will
be a key factor in realizing maximum
possible results using eClinical systems.
The eClinical transformation offers a
chance to maximize the value of clinical
trials, improving pharmaceutical
development efficiencies and ultimately
providing patients with timely, new, and
improved treatment options.
Clewlow_new.qxp 15/5/09 5:14 pm Page 5
The perception of ‘big pharma’ used to be that of change-averse,
slow-moving clinical trial leviathans, but that view is now largely
obsolete. Many pharmaceutical firms have slimmed down and
outsourced a lot of their non-core work. Behind the scenes they have
been investigating electronic and remote data capture (EDC/RDC)
technologies, working not only to improve the quality of trials and thus
the data acquired, but also to make the whole process less onerous for
clinical investigators. To this end, Pfizer has been working with Oracle on
improving its RDC offering, ensuring that it can keep up with the
demands of investigators, the rigors of performing global clinical trials,
and the changing economy as a whole.
In many ways, the changing clinical trial environment is only a reflection
of the changes endemic to the rest of the economy. In testing times,
when cash and credit are scarce, it is vital to contain the number of trials
that are being run and remain focused on core areas of interest.
Specifically, in terms of data management, the important facts to
consider are how and where trials are placed. This means working with
investigator sites to make sure that they have the technology needed to
enable them to deliver the data. Technology becomes more important as
an organization’s presence grows worldwide. These days, most of the
data management functions of a pharmaceutical firm are outsourced, so
the other crucial element is how these vendors are managed. From a
regulatory perspective, a pharmaceutical company must be able to prove
it has transparency over the trials and is maintaining effective oversight
to the vendors, as well as obtaining appropriate-quality data.
The Changing Nature of Pharma
As recently as the late 1990s it was the sponsor organization’s
responsibility to set up a trial. A sponsor such as Pfizer would have had
to locate study sites around the world with access to a suitable
population. The sponsor would also be responsible for hiring and training
trial staff and ensuring that they were conducting their work using the
appropriate processes and procedures. However, whereas clinical trials
are critical to the pharmaceutical development process, this sourcing and
resourcing process is not a core competency of a pharmaceutical firm.
Gradually, pharma have moved away from this ‘hands-on’ work and, to
a certain extent, become detached from the market.
In parallel—and almost certainly partly responsible for this trend—
contract research organizations (CROs) have gained an advantage: they
understand the market dynamics, have contacts in low-cost countries,
and have a core competency in staff management. CROs are now the
universal link between the pharmaceutical firm running the trial and
the staff that administrate it. Of course, outsourcing is not a new
phenomenon, but in the last decade it has taken on a new importance
as pharma have grown in size and off-shoring has become the norm.
However, some of the challenges faced by pharmaceutical companies
have changed. Financial pressures—always a challenge for any
business—have taken on a new meaning: now the emphasis has shifted
toward ensuring that the vendors chosen are not only high-quality and
technologically advanced, but also that they have the financial ability to
withstand the ups and downs in the market. This has led to many of the
service and technology providers merging and the market as a whole
consolidating. These new super-vendors now mirror the peaks and
troughs in the primary pharmaceutical market.
Furthermore, price is now no longer the only variable. Pharma are
demanding more efficiencies from their vendors, looking for nimble and
agile companies as well as large or strong ones. In order to eliminate
waste and inefficiencies, many vendors are employing modern
management techniques such as lean manufacturing and six sigma
quality control processes. The whole industry is raising its game.
The Quality Game
Along with expectations and internal processes, the quality of the
relationship between sponsor and vendor has also risen. In nearly all cases
these relationships have moved from being simply a transaction for a
service or technology to a deeper, value-generating partnership with
shared goals and a co-identity—true joint ventures. When a pharma
outsources the bulk of its work, it needs to become intimate with its
suppliers. Even across multiple vendors there is a sharing process; good
ideas usually come from several areas. Each one of the different providers
that are part of the project needs to share that process or that good idea.
In turn, in order to become more efficient suppliers need to have access to
all relevant information; the pharma also needs to share more and properly
trust its partners. In the best examples, this sharing attitude permeates all
organizations that are part of the partnership: staff from those companies
a report by
Robert R Goodwin
Vice President, Global Clinical Data Services, Pfizer, Inc.
State-of-the-Science—The New Remote Data Capture Paradigm
© T O U C H B R I E F I N G S 2 0 0 9
Robert R Goodwin is Vice President of Global Clinical DataServices at Pfizer. In this role, he is responsible for thedelivery of cost-effective and efficient centralized datamanagement activities for Pfizer and for the strategy andexecution of near-shore and off-shoring opportunities. Hehas introduced concepts of lean and six sigma to create amanufacturing mindset for data management, with a focuson cycle times, removing handoffs, and creating repeatabletasks for improved productivity. Mr Goodwin has 20 years of
industry experience in statistics, SAS programming, data management, electronic datacapture, and strategic project management. His previous positions include roles in theacquisition teams concerning the Warner Lambert and Pharmacia acquisitions, withresponsibility for data and processes. Mr Goodwin holds a BSc in psychology from EasternConnecticut State University, an MSc in research, measurement, and evaluation fromSouthern Connecticut State University, and an MBA in pharmaceutical and chemical studies.
State-of-the-Science New RDC Paradigm
6
Pfizer_Goodwin_subbed.qxp 18/5/09 12:28 pm Page 6
sharing their goals have a greater sense of belonging, which in practical
terms translates into more loyalty and a lower staff turnover.
Of course, there are many different outsourcing models. The traditional
one-off single-trial approach where the sponsor company will pay to
receive a data set at the conclusion of the trial is still extant. A sponsor
may take a more strategic attitude and outsource in a certain area or
indication, yet still rely heavily on the CRO and its data management
systems to provide the data sets. The third option is for a sponsor to take
a strategic approach but to employ its own systems and retain more
control over data. Each model has inherent risks and benefits, and will
determine what is required in terms of technology and human resources.
The Pfizer Approach
Pfizer currently outsources its clinical trial activities through a select
group of preferred strategic providers, employing elements from all of
the aforementioned outsourcing models. The choice of model is very
project-specific: in some cases Pfizer uses the traditional full-service CRO
approach, with the CRO as the sole point of contact, while in others it
uses a hybrid model, which is a full-service CRO model using Pfizer
processing systems. The majority of the studies are run within the
Pfizer functional service provider (FSP) model. With the FSP model, unlike
in the traditional full-service model, vendors perform activity-based
services by function and have internal resources dedicated to the
sponsor firm on a full-time basis (see Figure 1). Furthermore, the vendors
use Pfizer processing systems and standard operating procedures.
Securing such a long-term, strategic, and intimate relationship is no
simple matter. Finding the right partners is an important first step. It is
essential that a partner organization share the same philosophies as
Pfizer, particularly from senior management; if there is the right
relationship and work philosophy at the top, this will filter down through
the organization to the rest of the employees. After mutual respect come
the metrics: being able to measure the business, the output, and the
throughput of each of the providers. However, overall, competition
between vendors is no longer about the work to be undertaken or its
price—it is about how an organization distinguishes itself, the ideas it
brings to the table, the quality of the data it provides, and the ease of the
collaborative process and the efficiencies it can permit.
Enabling Technology
In the new partnership paradigm, IT infrastructure becomes very important.
This applies as much to the basics (email, shared calendars, live meetings,
shared documents, etc.) as to the core technology of a trial—the data
capture system. However, while the former is simply a matter of connectivity
and is not process-specific, it is essential that the latter is standardized, and
it is not unusual for a sponsor company to dictate to its vendors which
platform should be used.
Initially, Pfizer developed its own proprietary EDC system, I-Net, which was
developed at a time when there were no dominant EDC vendors in the
market. Over and above simply providing an EDC system, the process of
development and management of I-Net gave Pfizer an insight into the
underlying EDC technology to understand it at a fundamental level and
learn how it works. It was not a completely smooth undertaking
and mistakes were made, which are in many ways more valuable in terms
of the learning curve than the successful decisions and actions. The main
outcomes of the I-Net pilot are that Pfizer learned about working with EDC:
that the IT systems and clinical development processes need to be aligned;
that the information acquired needs to be aggregated at the investigator
site; that any EDC tool used should not require retraining of the whole data
management organization; and that there should not be multiple
environments for paper and EDC. Above all, this pilot showed that the IT
skills required to maintain such a system were beyond what should be
considered the core capabilities of a large pharmaceutical organization.
I-Net was finally retired in 2007, and Oracle RDC is now routinely used
within Pfizer. The transition period was relatively painless as Pfizer
was already using much of the Oracle eClinical suite. Today, all
Pfizer-sponsored clinical trials use Oracle RDC for data capture, and
all Pfizer vendors also use it. This provides consistency regarding the data
sets and how they are processed. For investigator sites, it is a common tool
that they will use every time they participate in a Pfizer trial. For clinical trial
monitors, being able to routinely use and become familiar with a
7E C L I N I C A L V I S I O N S
State-of-the-Science—The New Remote Data Capture Paradigm
It is essential that a partner
organization share the same
philosophies as Pfizer, particularly
from senior management; if there is the
right relationship and work philosophy
at the top, this will filter down through
the organization.
Figure 1: Evolution of the Pfizer Service Model
CRO3 CRO2
CRO1CRO4 CRO5
CRO6CRO4
CRO6
Sponsor
Sponsor
Sponsor
Uncoordinated CRO model
Sponsor
FSP-3 FSP-X
FSP-1
FSP-2
FSP model
CRO = contract research organization; FSP = functional service provider.
Pfizer_Goodwin_subbed.qxp 12/5/09 4:34 pm Page 7
standardized toolkit also improves their efficiency and ability to perform. In
fact, it was only the way in which the system was perceived that required a
radical overhaul. Users needed to change their mindset and acknowledge
that Oracle RDC is more than simply a data management tool: it can be used
by many different stakeholders to improve and adapt the trial. Essentially, it
has become an enterprise-type application for clinical trials.
Benefits to Business
The adoption of RDC is more or less complete at Pfizer. When a new clinical
trial is set up, there is no question as to whether it is paper or not; it is
automatically assumed to be RDC. It is now considered to be a mature
technology, and one whose value is measured not by return on investment
(ROI) but by the efficiencies it brings and the new processes it enables.
The clinical testing phase represents approximately 40% of the cost involved
in developing a compound, which in total is measured in hundreds of
millions of dollars. The further through clinical testing a compound
progresses, the larger, more complex, and more expensive the trial
becomes. Therefore, it is always in the sponsor’s best interests to identify the
potential of a compound as early as possible and either commit to or
eliminate it. One way to facilitate identification is by using adaptive clinical
trial designs, where the database is periodically ‘soft-locked’ and the CRO or
sponsor can simulate a final analysis to see whether results are trending in
the right way. In some cases this happens with every patient, every visit
(EPEV)—a continuous cleaning strategy. It is extremely difficult to do this
with a paper-based system, but with RDC it is possible to visualize safety
profiles early on and make decisions about the progress of the trial.
It is not just the technical side of the RDC tool that benefits the
business; it also has a positive impact on human resources, namely
investigators. The Pfizer philosophy is to treat investigators as customers,
and to focus on providing them with the best experience possible. The
investigator pool is limited in size, and all CROs and sponsor companies are
effectively competing for their services. From the investigator point of view,
the interest in a clinical trial lies in the science, and that is what they are set
up to do. The easier and more intuitive the toolset is to handle, and the less
impact it has on the investigator site, the better. A system such as Oracle
RDC, which is Internet-based and therefore has a zero footprint, makes it
easier for the investigator to conduct their business.
Therefore, it is important to consider what investigators and monitors
need over and above purely data entry, for example programming of edit
checks, rethinking screen design, and access to more detailed information.
Investigators’ feedback on the case report forms (CRFs), technology used,
instructions, and response to queries and other items is a valuable input
that is used to improve the experience of working for Pfizer. Pfizer used
this information as part of the development process for the latest version
of Oracle RDC 4.5.3. Other companies also contributed to the upgrade,
which not only improves the software but also ensures that the platform
is more generalized, so the training overhead that any one sponsor needs
to provide when using RDC is already reduced. As more companies adopt
the same technology, technology becomes less of a competitive
advantage and the focus can shift to the science within the trials. The next
step, and what the industry as a whole is moving toward, is the
establishment of data standards to enable a common infrastructure
covering elements such as CRFs and the questions that form part of the
enrollment and follow-up process.
Science and Progress
Developing standards for trials, tools, and infrastructure will not be easy,
but every industry goes through a version of this process. Over time,
collaborative working has grown over wider geographical areas and
encompassed more people, and the only way to maintain the integrity of
the venture is to use the latest information and communication
technologies. However, these tools should be part of the process, not the
focus of it; they should facilitate the endeavors, not complicate them. In
this way they will enable progress and the development of new capabilities.
In the next few years electronic health records will overtake paper
records in the developed world. In many trials, more than half of the data
will come from sources other than the investigator sites, such as
laboratories, electrocardiograms, scanners, or other digital equipment.
The next big challenge will be working out how to interface with these
technologies. It is possible that what are now data management roles
may morph into ‘data broker’ roles, shepherding the flow of information
securely between systems and across organizations and countries. This
will be necessary in order to eliminate dual processing of information. It
may take another decade, but deploying a web browser fronting
proprietary software to gather data will not be the ultimate solution. It
may have taken a while for EDC to become accepted, but the field is
moving faster now. Pharmaceutical firms no longer have the same
apparently limitless resources and are increasingly not just adopting new
technology and practices but looking at ways to drive them forward.
Overall, the acceptance of technology is gaining pace. People all over the
world are more comfortable with electronic tools. Developing countries
still have an infrastructure issue that may never be—or need to be—
resolved. With wireless communication and better power acquisition and
storage capabilities, emerging countries can leapfrog many of the more
established countries and move full pace into the digital age. Big pharma
may have been lethargic in the past, but have now realized that it
benefits the whole industry to be able to easily, quickly, and securely
share data, and are helping to drive this process forward. Ironically, as
technology has improved, its status as a defining feature has reduced;
instead, it has mutated from being pivotal to being essential. ■
8 E C L I N I C A L V I S I O N S
State-of-the-Science New RDC Paradigm
As more companies adopt the
same technology, technology becomes
less of a competitive advantage and
the focus can shift to the science
within the trials.
Users needed to change their
mindset and acknowledge that
Oracle RDC is more than simply
a data management tool.
Pfizer_Goodwin_subbed.qxp 12/5/09 4:34 pm Page 8
As the pharmaceutical industry moves into the eClinical age, much is
changing and more change is possible. Technologies such as electronic
data capture (EDC) have enabled clinical studies to become larger and
more complex. Furthermore, they have supported the global expansion
of trials, particularly to patients in developing countries. However, the
introduction of EDC has also put more pressure on companies to
increase the scope of their trials, all while containing costs.
PPD is a large global contract research organization (CRO) working
within the trends of globalization and more complex eClinical trials.
The company’s large global presence means that clients can take
advantage of its economies of scale, while the web-based nature
of its primary platform—Oracle Remote Data Capture (RDC)—allows
easier access to trial data in a real-time fashion for safety and
monitoring purposes. Furthermore, PPD has worked as a beta tester
for Oracle’s latest offering, Oracle RDC 4.5.3, focusing on leveraging
the technology for investigator use and improving its data
management functionality.
Changing Face of Clinical Trials
Clinical trials are becoming larger and more complex but can be carried
out more quickly than ever before, all thanks to the adoption of
eClinical technologies. At the start of 2009, PPD is seeing 50% of its
trials undertaken in an electronic format. Within the next few years, it
is predicted that electronic trials will overtake paper-based trials, but
there will still be a need for paper trials for some specific trial types and
sizes. EDC platforms such as Oracle RDC allow investigators to monitor
trials more easily and to access and analyze vital data on a regular basis.
Such platforms also allow regulatory bodies and data safety
monitoring boards (DSMBs) easy access to trial data. Easier access
means that agencies such as the US Food and Drug Administration
(FDA) will be able to play a more participatory role in the setup and
running of trials to ensure that quality and standards are maintained
in this new wave of eClinical technology.
Business Goals
EDC has been a major enabling technology, allowing companies to
extend their business goals beyond what was possible with paper
systems. The web-based Oracle RDC 4.5.3 gives companies a larger
global reach to monitor and manage data across the world. Processes
such as collating all global data used to take four to six weeks, but can
now be performed in one to two weeks. Database lock time has been
reduced to 10 days (100–400% less time than when using paper).
However, while eClinical technologies have allowed the pharmaceutical
industry to make leaps forward in clinical trial management, they have
also increased the pressure to run faster trials that enroll even more
patients. This puts pressure on trials to become more global, particularly
as it becomes more difficult to find treatment-naïve patients closer to
home. In addition, the cost of drug development is rising, but the
pressure remains on pharmaceutical and biotechnology companies
to contain costs.
In the face of these changing times, CROs can help ease the pressure
for their clients. A client can take advantage of the experience and
economies of scale of a large CRO, such as PPD. Global CROs have
more contacts and investigators in various countries worldwide,
including in the developing world, and they can generate efficiencies
in terms of data management.
Globalization
Clinical trials are increasingly pushing out into new global locations,
and the spread has been particularly rapid in developing countries. This
means that CROs need to be global too (see Figure 1). PPD has been
running studies spanning the globe, with offices in 33 countries
worldwide. As well as multiple offices in North America and Europe,
the company has a large number of bases in Latin America and Asia,
an office in South Africa, and one in Israel. PPD is continuing to expand
its presence, anticipating a rise in trial volume in these regions.
a report by
James Streeter
Executive Director, Electronic Data Capture, PPD, Inc.
Improving and Monitoring Clinical Data Management in the eClinical Age
9© T O U C H B R I E F I N G S 2 0 0 9
Improving and Monitoring Clinical Data Management
James Streeter is Executive Director of Electronic DataCapture (EDC) at PPD, Inc, a position he has held since2006. He applies his extensive experience in EDC, dataacquisition, data management, and analysis, workingdirectly with clients to incorporate EDC into theirdevelopment programs. As the leader of PPD’s globalEDC core team, he provides project teams with thetechnical process and training support services necessaryto ensure proper deployment and execution during the
critical start-up, monitoring, and close-out phases of clinical studies employing EDC. MrStreeter gained much of his EDC experience at Pfizer as Senior Director of Global ClinicalData Services, heading the Global Data Acquisition Department for the company’s globalresearch and development organization. Prior to joining Pfizer, he was a senior hardware,software, and systems engineer for the US Navy Underwater Sound Laboratory, with afocus on data acquisition and analysis.
At the start of 2009, PPD is seeing
50% of its trials undertaken in an
electronic format. Within the next few
years, we predict that electronic trials
will overtake paper-based trials.
PPD_Streeter_revised1.qxp 12/5/09 4:35 pm Page 9
With a totally web-based platform such as Oracle RDC 4.5.3, these
disparate locations can communicate effectively. Employees can log in
from various locations both on- and off-site to manage, monitor, and
analyze data. The platform has a footprint of zero—it needs no
installation at the actual trial site—thus avoiding many potential setup
issues. Full training for the system can be achieved in 45 minutes to an
hour, and if a site already has experience using another EDC program,
the process is even easier.
New Research Areas
As companies push further into these new regions, it is important to
remember that many sites will be new to clinical research. In such
cases, implementing eClinical technology can prove challenging.
Moreover, relationship building and proper training is needed to
promote investigator confidence in using these platforms. Getting
clinical sites up and running can be especially problematic in
developing countries that lack the standard IT infrastructure.
However, technology challenges in these areas are starting to improve.
Technology is spreading rapidly and many of these regions are gaining
high-speed Internet links and other forms of access. Countries are
generally willing to adapt to eClinical demands quickly, with
investigators keen on using new technology platforms that can boost
their clinical trial parameters. Particularly poor areas, such as some
regions in Africa, completely lack basic communications infrastructure
such as telephone lines, and are likely to do so for some time to come,
but they have already made the leap to using cellular phones based
on wireless networks. New eClinical technologies that can run using
wireless communication networks or satellite links are emerging,
effectively bypassing the need for a classic IT infrastructure.
Enhancing the Investigator Experience
The importance of the investigator in implementing eClinical trials has
long been overlooked, but now enhancing the investigator eClinical
experience is becoming a key part of leveraging such technologies.
EDC platforms need to be user-friendly to give an investigator
confidence in using the system and to increase the efficiency and trial
workflow rather than slow it down. Finding clinical investigators is very
competitive and CROs are having to work harder to retain them.
There is also demand for an eClinical tool that allows investigators to
handle larger volumes of complex data more easily. With Oracle RDC
4.5.3, case report forms (CRFs) are easy to navigate and provide search
and sort functions and a robust system of edit checks to ensure data
accuracy. There is a combined interface for discrepancy management
and the CRF itself on one screen, so that users can scroll through and
work on discrepancies without having to add pop-up windows or use
different tools. In addition, investigators can interact with monitors
and data management teams in a more real-time fashion, which
means that they are able to close queries within days—something that
could take one to two months with paper-based systems.
10 E C L I N I C A L V I S I O N S
Improving and Monitoring Clinical Data Management
PPD global offices
Number of clinical trials
Canada = 4,768US = 33,369Mexico = 774Carribean = 1,010South America = 1,576Europe = 13,080Africa = 1,362Middle East = 1,952Russia = 947East Asia = 838China = 3,249Australasia = 1,882Japan = 907South-East Asia = 901
0–1,000
1,000–2,000
2,000–10,000
10,000–20,000
20,000–40,000
US (26)
Canada
Mexico
Peru
Chile
BrazilSouthAfrica
Belgium (2)UK (4)France
GermanyItaly
The NetherlandsSpainPortugal
SwedenDenmarkPolandCzech RepublicHungary
TurkeyGreece
Australia
Taiwan
Thailand
Singapore
India (2)
China (2)
Korea
Israel
Figure 1: Globalization of Clinical Trials and of PPD
Source: www.clinicaltrials.gov, July 2008.
Electronic data capture platforms
need to be user-friendly to give
an investigator confidence in using
the system and to increase the
efficiency and trial workflow rather
than slow it down.
PPD_Streeter_revised1.qxp 12/5/09 4:35 pm Page 10
Of course, the platform also literally reduces the volume of paper used,
so investigators no longer have to find storage for bulky casebooks. All
clinical data can be stored on a CD.
An Agent of Change
PPD has worked closely with eClinical providers such as Oracle
specifically on Oracle RDC, as well as its business intelligence, safety
packages, and clinical trial management system (CTMS). As part of its
strategic development partner (SDP) program, PPD has acted as a
customer advisor and worked as a beta tester on a pre-release version
of RDC 4.5.3. PPD’s investigator focus made it able to provide feedback
to Oracle on various issues and act as a voice for its various investigator
sites. PPD’s participation has helped increase investigator site
performance, simplify the user interface, eliminate software installation
issues, and realize a fully web-based system.
PPD particularly focused on how various eTechnologies would be used in
practice by investigators and assessed how the various tools could make
the job of the investigator easier. In the first instance, the firm directly
questioned investigators, asking what eClinical abilities they would need
to optimize their resources. The company also visited various investigator
sites as part of its research, getting feedback from investigators and
testing the systems first-hand to establish which add-on elements would
improve the platform and help trial management run more smoothly.
By focusing attention on investigator usage, PPD has become a
technology leader in the eClinical field. Understanding the
investigator’s technology needs improves the investigator’s relationship
with eClinical systems and its relationship with the CRO. As a result,
PPD is better able to retain investigators in wide-ranging global
locations, making it a more attractive proposition for potential clients.
It is not just investigators that have to cope with the switch to
eTechnologies; CROs must adapt too. Employing eClinical platforms
means huge changes for the day-to-day workflow of monitors and
project management staff. PPD has implemented comprehensive
training programs and hired employees experienced in using such
platforms. Once employees have sufficient training and are exposed to
eClinical studies, they start to feel the benefits to their workflow,
finding they can work faster and more efficiently, managing data and
responding to queries in real time.
Technology Integration
Unusually for a CRO, PPD also has its own informatics division—
CSS Informatics—which provides software for pharmaceutical,
biotechnology, medical device, and other CRO companies and offers
consulting services for clinical trial and drug safety applications.
CSS Informatics can host all types of eClinical EDC system for
clients and provide training on their use. As a result, PPD has
experience using a variety of eClinical systems on the market,
performing approximately 125 studies using Oracle Clinical RDC and
80 studies using third-party EDC platforms. The combination of PPD
and CSS Informatics’ service offerings creates a broad, integrated
service for clients.
Along with Oracle’s RDC platforms, PPD also has an in-house EDC
system. While Oracle’s RDC is more geared toward phase I–III trials,
which are more standardized in their trial management processes,
PPD’s proprietary EDC platform—GlobalView—is used for post-
marketing and medical device trials, as it allows for more dynamic
control of these extended and highly variable studies. As GlobalView
has a programming ability, PPD can integrate its system with Oracle
RDC to share data across both systems.
Future Perspectives
With each phase of eClinical development, technologies are
increasingly able to cope with larger, more complex trials, a trend
that is likely to continue into the future. For CROs, one of the biggest
issues will be ensuring adequate training for employees and
investigators using these systems. The future direction of all of these
systems will be determined by how well we can consolidate them and
integrate data.
Currently, there are a variety of eClinical systems, including CTMS and
safety and database management systems, that tend to work
separately. In the future, companies are looking to combine and
integrate these systems using data warehouses and business
intelligence, ending the need to sort data manually. In addition, web-
based platforms will make it far simpler for systems to communicate
with each other.
Eventually, technology will progress to where firms only need to set up
one central system to control all variables within the eClinical
paradigm. A single massive coordinated system would have a single
login for users to view all aspects of the trial in real time at any time.
Clinical trials using such a system would create cost and time savings,
allowing CROs to run their studies more efficiently and to collect
higher-quality data. The end result would be a more integrated
approach to eClinical technologies and faster, larger, and less costly
clinical trials. ■
11E C L I N I C A L V I S I O N S
Improving and Monitoring Clinical Data Management in the eClinical Age
Understanding the investigator’s
technology needs improves
the investigator’s relationship
with eClinical systems and its
relationship with the contract
research organization.
With each phase of eClinical
development, technologies are
increasingly able to cope with
larger, more complex trials.
PPD_Streeter_revised1.qxp 12/5/09 4:36 pm Page 11
C3i_ad.qxp 8/4/09 4:50 pm Page 12
The use of electronic data capture (EDC) technology is becoming more
widespread: estimates are that approximately half of all trials now
employ EDC, and 32% of sites use Internet-based EDC,1 with spending
on EDC solutions set to exceed $3 billion by 2011—a 15% growth rate
from 2007.2 This means that sponsor companies have the capability to
run more complex and cost-effective clinical trials across the world.
Systems such as Oracle’s Remote Data Capture (RDC) platform are
designed to help sponsors and contract research organizations (CROs)
retain efficient and effective control over clinical trials in an
increasingly regulated industry. While new technology can be a great
enabling tool, it must be simple and useable for those at the heart of
the trial—the investigators. Burdening investigators with unwieldy,
intractable new technologies will not improve efficiency and can even
be detrimental to the progress of the trial.
In order to optimize the use of this innovative and promising
technology, investigators need access to training and specialized
technical support. Consequently, as the use of EDC platforms has
grown, so too have expert technology service companies such as C3i,
which act as a bridge between the investigator and the sponsor
company to provide that support network. C3i aims to maximize the
benefits derived from these enabling technologies and smooth the
transition from old to new technologies for investigators, whose main
focus needs to be on conducting the trial as efficiently as possible.
Clinical Trials and Tribulations
In an industry where new technology is constantly replacing old and
new challenges are being met, clinical trial design and management is
also progressing. EDC methods represent an important leap forward in
clinical trial technology, allowing for more reliable record keeping,
easier access to data from multiple sites across the globe, and larger
trials that can be completed more quickly and efficiently than ever
before. However, the transition period while implementing any new
technology is unlikely to be entirely smooth. Programs such as Oracle
RDC will undoubtedly improve and modernize clinical trial operations
in the pharmaceutical industry in the long term, but setting
up the new platform or upgrading the old one can present many
challenges in the short term, one of the biggest of which is to make
the entire environment user-friendly for investigators and investigator
site staff.
The Growing Demand On and For Investigators
While pharmaceutical companies and CROs will be highly familiar with
the technology they are working with, the same is not true of
investigators. It is important to remember that investigators will have
other daily duties alongside running trials, many of which will require
their own tools. Any time spent struggling with a program or
technology for a specific trial will be a substantial burden on their
resources, and is unlikely to give them a positive view of the trial
sponsor. For them, EDC should be an enabling tool that helps
streamline workflow. However, this has not always been the case; in
the past, such programs have rarely been designed with investigators
in mind.
In addition, recruiting investigators for a study is a critical process, and
one that is getting harder as the number of trials rises (see Figure 1).
Sponsors and CROs effectively have to compete for the best
investigators, who should therefore be treated as customers rather
than employees or associates. Thus, the sponsors and CROs must be
easy to work with, and that is reflected in the technology they use. It
Optimizing and Supporting Remote Data Capture
a report by
Dave Hanaman 1 and Rob Vol lkommer 2
1. Executive Vice President and Co-Founder; 2. Vice President, Clinical Services, C3i, Inc.
Optimizing and Supporting Remote Data Capture
13© T O U C H B R I E F I N G S 2 0 0 9
Dave Hanaman is Co-Founder and Chief Sales andMarketing Officer for C3i. He is responsible for sales,marketing, product development, and alliances.Additionally, he consults directly with many of C3i’s blue-chip clients. He is experienced in a wide variety ofsubjects related to clinical support operations andcustomer relationship management, focusing on thetechnology environment, performance improvement, andreturn on investment. A frequent lecturer and prolific
writer, Mr Hanaman has developed and taught courses for universities, spoken at industryconferences, and written numerous articles, and is frequently quoted in the industry press.A graduate of the University of California at Berkeley, he also served as an IntelligenceOfficer in the US Navy.
Rob Vollkommer joined C3i in November 2002, and iscurrently Vice President of Clinical Support Services.He is responsible for the development and delivery ofsupport services to meet the specific requirements of thecompanies conducting clinical trials (e.g. multilingual helpdesk, user accounts creation/administration, technical siteassessments, and Internet-based training). He holds a BScin electrical engineering from Columbia University and anMBA in management and operations management fromNYU Stern School of Business.
Electronic data capture should
be an enabling tool that helps
streamline workflow.
C3i_Volkommer_revised2.qxp 18/5/09 12:30 pm Page 13
is vital for the sponsor to have user-friendly technology and an
effective support network to train and assist investigators.
Until recently, the problem of investigators struggling with new EDC
technologies had been underestimated and under-appreciated. The task
of supporting them tended to fall on site monitors—the clinical research
associates (CRAs). However, this meant that CRAs could themselves
become overburdened with technical support issues, leaving them with
less time to carry out their core role. This is where C3i steps in: its support
network works to alleviate pressure and minimize time-consuming
interruptions for the CRA, help the investigator to use the technology
effectively, and prevent the new technologies from becoming a burden.
In addition to usability, the total cost of ownership is an important
factor. Any new technology requires substantial start-up capital. It
is important to leverage such technologies to maximize their potential
for the sponsor and the CRO and reduce costs in the long run.
Effective setup, training, and support shortens the time to a return
on investment.
Integrating Technology
Along with new technologies, trials themselves are becoming more
complex. In fact, this is a self-sustaining cycle: innovative technologies
have enabled trials to become larger, covering multiple sites in many
countries across the globe, which, in turn, increases the volume of
information flow from site to site. Furthermore, while EDC is growing
in acceptance, it is far from universal. There are currently many
different data modalities within a trial that must be dealt with,
including lab data, which is often faxed through, adverse event
reporting and safety issues, which are not yet fully electronic, and
decisions taken about protocol adjustments on the trial.
In fact, the running of clinical trials is likely to become even more
complex for many investigators even as they begin to realize the
benefits of EDC technology. It will take a while until EDC has
penetrated all aspects of a trial. Indeed, EDC is not the only electronic
system that runs during a trial. For example, although the sponsor and
the CRO will use the same data collection platform, the CRO may use
its own system for clinical trial management or other parts of the study
such as enabling payments. In such a case, integration of the sponsor
company and CRO systems may remain a challenge for the foreseeable
future—a barrier that could hinder progress for some time.
Companies such as Oracle are working hard to streamline technology
to allow integration of all aspects of clinical trials. The ultimate goal
is to simplify the total solution so that there is one central point for
access to all the different aspects of the trial—a kind of ‘dashboard
portal’ where investigators, CROs, and sponsors can reach all of these
disparate systems through a single login. However, the industry is not
there yet. There is still a strong need for technical support to help the
investigator navigate and deal with this complexity and lack of
integration, and this is where a company such as C3i can intervene and
help investigators navigate such systems, with the goal of making the
overall research process more efficient.
Implementing and Supporting Large-scale Global Trials
There are many consequences of running large-scale global trials. For a
start, there is added pressure to recruit the best subjects. It is becoming
increasingly difficult to find treatment-naïve patients in Western
countries; therefore, attention is being focused on the East, toward
countries such as Russia and China. This, in turn, introduces complexity
to the support process, which must now handle different languages
across multiple time zones.
Connectivity is another issue: modern multicenter trials heavily rely on
adequate Internet access so that sites can communicate effectively
with each other and with the sponsor. Investigators in developing
nations may not have regular access to a reliable Internet connection,
or in some cases even a computer. Using such investigators may mean
having to ship out equipment and laptops just so they can access EDC
applications, including Oracle RDC, which will significantly affect the
budget for the study. As a rule of thumb, if a sponsor is considering
using investigators in Russia, China, or maybe Latin America, it will
need to plan to provide 10–14% of sites with computers; that figure
would be just 1–2% in the US (see Figure 2). In addition, companies
14 E C L I N I C A L V I S I O N S
Optimizing and Supporting Remote Data Capture
Number of investigators
2000 2004 2007 2009
Num
ber o
f inv
estig
ator
s/tr
ials
Number of trials80,000
70,000
60,000
50,000
40,000
30,000
20,000
10,000
0
*Estimated. Sources: Thomson CenterWatch, Clinicaltrialstoday.com, Clinicaltrials.gov, Laine et al.3
Figure 1: Competing for Investigators
Modern multicenter trials heavily rely
on adequate Internet access.
Until recently, the problem of
investigators struggling with new
electronic data capture technologies
had been underestimated and
under-appreciated.
C3i_Volkommer_revised2.qxp 12/5/09 4:37 pm Page 14
need to assess the Internet activity and bandwidth at these sites to
ensure they can cope with the demands of the EDC technology. These
are all important considerations in terms of potential returns on
investment from the trial.
Critical Need for Training
Trying to understand any new EDC technology platform can seem
daunting at first, and training and support are essential to smooth its
acceptance. The next-generation Oracle RDC technology offers
increased functionality and investigators will require guidance to
optimize their use of the platform. Investigators are the lynchpins of
a clinical trial, but without proper support they can easily become a
trial’s weakest link.
C3i’s role is to help smooth the course of the clinical trial, increasing
the confidence of the investigator and taking the pressure off the
CRA. The company also helps to get the site up and running, sending
out new equipment and laptops if required. As part of this, C3i
performs speed tests for Internet connectivity—something that can
mean the difference between using or not using a site. C3i has
compiled some interesting statistics related to this. During study start-
up, it is not uncommon to have anywhere from five to nine inquiries
from each site over the course of a month, depending on sponsor-
specific start-up procedures (see Figure 3). Traditionally, these inquiries
are handled by the CRAs, but as CRAs manage multiple sites and have
to travel between them, a backlog can quickly develop, increasing
their workload and response times. C3i removes this burden from the
CRA and enables investigators to experience quicker resolutions and
more customer-friendly experiences.
The company operates a 24-hour multilingual helpdesk that
understands the needs of the clinical business and is equipped to deal
effectively with inquiries from sites across the globe whatever the issue,
from losing a password to a program-specific technical problem
(see Figure 4). C3i’s helpdesk services are ISO9001-2000-certified and are
grounded in mature audit-tested processes and procedures for
everything including hiring, training, knowledge management, and
quality assurance. The bottom line is that better training and a more
efficient setup will mean fewer problems downstream, including fewer
helpdesk calls, since less support is needed. These are all potential savings
on long-term costs.
Training the Investigator
C3i begins investigator training with a basic awareness-raising
presentation that introduces the basics of using Oracle RDC. This acts
as a primer for the next stage, which is a self-paced, Internet-based
eLearning system. The 90-minute program can be accessed by users at
their leisure at any time before patient recruitment starts.
Furthermore, investigators do not need to complete the 90 minutes in
one session; the program can be spread over a more manageable
time-frame if required. Once completed, users are given a short
certification exam to ensure that they have understood the training.
The assessment is not intended to be a complicated exercise, but
rather a tool to show due diligence.
The training information is stored online, which is also useful for
regulators and any auditor who wants to check that all investigators
are qualified to use the equipment. Once complete, investigators
15E C L I N I C A L V I S I O N S
Optimizing and Supporting Remote Data Capture
Figure 3: Number of Interactions Handled by Support DeskDuring Study Start-up
10
9
8
7
6
5
4
3
2
1
0Client 1 Client 2 Client 3
9.2
5.4
Interactions per site handled by support desk during study start-up
9.1
Sample size >1,400 sites.
Better training and a more
efficient setup will mean
fewer problems downstream,
including fewer helpdesk calls.
During study start-up, it is not
uncommon to have anywhere from five
to nine inquiries from each site over
the course of a month.
Num
ber o
f site
s as
sess
ed
Region
Number of sites assessed Percentage of sites provisioned
15%
11%
7%6%
Sites provisioned (%)
3,500
3,000
2,500
2,000
1,500
1,000
500
0
16
14
12
10
8
6
4
2
0Asia-Pacific Latin
AmericaEurope Africa South
AmericaNorth
America
8%
2%
Sample size >8,000 sites. Source: C3i.
Figure 2: Laptop Provisioning Rates by Region
C3i_Volkommer_revised2.qxp 18/5/09 12:36 pm Page 15
receive their user ID and credentials and are able to access and use the
system as part of their project.
Case Study—Global Contract Research Organization
One successful case where C3i used its technical support expertise for
Oracle RDC involves a global CRO. The firm was setting up a large
project involving 1,000 sites in 40 different countries that needed to
be up and running in just 90 days—a major challenge. With C3i’s help,
the project was initiated within the time constraints by helping to
streamline the setup and workflow.
The first steps were to establish the RDC training program, starting
with building the eLearning environment for the investigators.
Following this, C3i began technical site assessments, checking that all
sites had appropriate computers and Internet connectivity.
Accordingly, the company shipped laptops to any global sites without
suitable hardware. The next step was to create user IDs for all
individuals who needed to interface with the RDC program.
On average, there is one investigator, one study nurse, and one study
coordinator per site, making a total of around 3,000 user IDs for this
project alone. As part of its work, C3i was also able to take on tasks
normally performed by the CRAs, leaving them better able to focus on
aspects more central to their job, such as recruitment and clinical audits.
For this project, C3i was working with Oracle RDC 4.5.3—the most
recent upgrade—and the improvements in this version could be clearly
seen with the more efficient implementation. The site assessment
process, for example, was far smoother with the new version, which
directly accelerated the process of getting the study up and running.
There was also a 5–15% reduction in basic usability questions from
investigators at the helpdesk, which is particularly impressive when
installing a new platform.
Overall, this global CRO was able to impress the sponsor company by
getting the trial up and running in a relatively short time-frame. The
eLearning environment proved very successful, and the number of
helpdesk calls was far below the number forecast. The end result was
a satisfied investigator, a CRA who was not too stretched in their
duties, and a CRO that met its timelines for a very important sponsor.
Benefits in the Future
New EDC platforms such as Oracle RDC can dramatically increase the
functionality of clinical trials, allowing for more complex and
demanding trials that are run more efficiently. However, it must not be
forgotten that at the heart of the clinical trial is the investigator—and
it is critical that his or her needs are met. Effective investigator training
is therefore a must in order to reap the benefits of this promising
technology. Continued support for the investigator throughout the trial
via companies such as C3i will also mean more efficient use of the
technology, more satisfied, engaged investigators, and improved
returns from investment in these enabling technologies.
Appropriate training and support will also lead to a better investigator
experience, which will be inextricably linked with the CRO and the
sponsor company, giving them a strong competitive edge. In the long
term this could boost investigator retention rates—an important result
in a field where investigators are a valuable commodity. ■
16 E C L I N I C A L V I S I O N S
Optimizing and Supporting Remote Data Capture
1. CenterWatch, EDC Adoption in Clinical Trials, A 2008 Analysis,2008. Available at: www.bio-itworld.com/EDC-ADOPTION.aspx
2. Health Industry Insights, US Electronic Data capture2006–2011, Spending Forecast and Analysis, 2007.
3. Laine C, et al., Clinical trial registration—looking back andmoving ahead, N Engl J Med, 2007;356(26):2734–6.
Figure 4: Typical Problems Handled by Helpdesk
26%
24%
22%
10%
EDC study
Oracle RDC support
7%
1%
24%
36%
11%
9%
9%
7% 5%5%
3%1%
0%
Oracle RDC
Password reset
User account management
Clients’ web portal
Citrix (Gateway for previousversions of Oracle RDC)
Provisioning
User account issue
Other Oracle RDC issue
Error message
Time-out/disconnection issue
Data entry issue
Training issue
Inserting page/visit
Verification/approval
Discrepancy/query
Blanking or unblanking pages
Major event (0%)
In the long term this could boost
investigator retention rates—
an important result in a field where
investigators are a valuable commodity.
The firm was setting up a large
project involving 1,000 sites in 40
different countries that needed to
be up and running in just 90 days—
a major challenge.
C3i_Volkommer_revised2.qxp 12/5/09 4:37 pm Page 16
Clinical Trial Management(Siebel Clinical)
Electronic Data Capture(Oracle Remote Data Capture)
Clinical DataManagement System
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Safety Reportingand Call Center
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Term Classification/Dictionary Management(Oracle Thesaurus Management System)
Clinical Integration, Warehousing, and Reporting(Oracle Life Sciences Data Hub)
eClinical Visions
Oracle Health Sciences—Clinical Development and Safety Applications
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