DOLSR CROOpenText Life Science Suite for

Contract Research Organisations

M Y N A M E I SED STEENHOEKMANAGER BUSINESS SOLUTIONS

CONNECTING PEOPLE

TO THE ENTERPRISE

ENTERPRISE

INFORMATION

MANAGEMENT

In the days that software was developed in isolation before it

was thrown over the wall to its users, ease of use was not on

the radar. At its best, the user experience was moulded after

the likes and dislikes of its developer. Those days are gone.

IT lost its budget to the business and they do want to spend

time and money on a good user experience (UX).

Ease of use is one of the elements of that UX. Today, UX

is always discussed when new software is developed or

purchased. Unfortunately, that is no longer sufficient. Our

world has changed and the way we work is no longer limited

to the brick and mortar of our companies. This brings a

new dimension to ease of use. That now reaches into other

organisations.

Pharmaceutical companies e.g. outsourcing trial work to

contract research organisations (CRO’s). But a CRO works

for more than just one company. Worst case that could lead

to either a CRO working with multiple trial management

solutions or a single solution with the need for content

transformation between their own solution and the required

delivery format. Fortunately, within the Life Science industry,

there is DIA. They defined the eTMF reference model and

some of the larger issues were solved. Unfortunately, there

is only so much they can do. That reference model is good,

but does not ensure easy of use.

Today, we work more and more in formal and informal

joint venture kind of structures that go beyond corporate

boundaties. This leads allmost to a guarantee that the

required ease of use translates into: KISS. Keep it simple,

stupid. For an EDMS, that is a real challenge.

Not so for the de facto collaboration suite that we all

use: Microsoft Office. The combination of an EDMS like

Documentum and the collaboration features in the Microsoft

suite can support ease of use in the extended enterprise.

And it can support the CRO in the challenge of keeping

everybody happy when they work for multiple sponsors.

Business solutions like Collaborative Edit or Collaborative

Partner Exchange are examples of going the extra mile

towards ease of use. Pre-configured for a particular purpose.

Yes, there is an integration framework underneath, but that

doesn’t matter. For the sake of ease of use, integrating

Documentum and Office 365 doesn’t stop there. It will only

be the beginning.

Ease of Use is Not a Product Feature, Only the Lack of It is a Problem for the Users

Jeroen Jansen, CEO

Ed SteenhoekManager Business Solutions AIIM Certified Information Professional Member of the AIIM Leadership Council

eTMF Partner Exchange

Fast and Accurate Trials Compliance

With OpenText Documentum for eTMF, you can effectively plan, collect, and maintain essential clinical trial documentation. You will realize gains in efficiency, consistently manage clinical trial documents according to Good Clinical Practices, and ensure inspection-readiness

Collaborative Partner Exchange Only enables full control over external content from clients and partners. Only content that meets your quality standards will be transferred to the Documentum repository. Includes automated meta data enrichment to comply with your dictionaries.

The eTMF module streamlines file planning at product, trial, country, and site level. Through automated file-planning templates, an expected document list can be quickly created. The end result is faster submission of regulatory packages sent for Institutional Review Board / Independent Ethics Committee approval

With Documentum for eTrial Master File, organizations can clearly prove 21 CFR Part 11 compliance with extensive audit trails and access controls, including e-approval and e-signature support, document distribution, version control and lifecycle management.

Collaborative EditCollaborative Edit enables working simultaneously in the same document with real-time updates of edits or comments made by co-authors and co-reviewers improves quality and efficiency. No need to reconcile individual changes afterward. Ready to support both internal and external users.

ExpandableBecause no Documentum implementation is the same, it is possible to expand the DOLSR CRO to neatly fit any environment. Other modules of the Life Science suite can be added or other products (e.g. Informed Products’ Collaborative Edit) can be added.

What are the characteristics of DOLSR CRODOLSR CRO is a business solution that leverages the technical capabilities of 3 products. The main part is the eTrial Master File module of OpenText Documentum for Life Sciences,. This is enhanced with Informed Products’ Collaborative Edit for real-time content collaboration and Informed Products’ Collaborative Partner Exchange for controlled exchange of information with partners or clients.

eTrial Master File moduleHow to benefit from the

Documentum for eTMF is a purpose-built solution that leverages Documentum, the industry’s leading and most scalable content management platform. Documentum for LifeSciences harnesses an information architecture based on the industry-standard Drug Information Association (DIA) Electronic Document Management (EDM) and ElectronicTrial Master File (eTMF) reference models for consistent document modelling. Documentum for eTMF takes advantage of this robust platform to address the challenges of planning, creating, collecting, tracking, analysing, and maintaining massive volumes of trial documentation on a global basis.

Benefits that the eTMF module provide• Accelerate study set-up and configuration• View, upload, and work on clinical documentation via an investigator portal• Seamlessly collaborate with CROs, inspectors, and other third parties for document collection and synchronization• Track real-time progress of clinical trial documentation• Improve TMF quality via an intuitive and configurable quality check process• Gain actionable insight through interactive dashboards and metrics reporting• Be continually prepared for inspections and audits• Demonstrate compliance through extensive audit trails, access control, lifecycle management, and version control

Driven by the skyrocketing costs of clinical trials, many life sciences companies rely on contract research organizations (CROs) for the vast majority of trials. But adding more resources—especially third parties—also adds enormous complexity to trial document management. The coordination necessary to collect and maintain vast numbers of trial documents, and to keep track of required documents in the context of the trial’s progress, is a monumental task and one that can expose both the sponsor and the CRO to compliance risk.

With OpenText Documentum for eTMF, you can effectively plan, collect, and maintain essential clinical trial documentation. Both sponsors and CROs can reduce complexity and risk by controlling and synchronizing study artefacts, tracking progress in clinical trial documentation collection, and ensuring fast, secure access to documentation both during and after trials. You will realize gains in efficiency, consistently manage clinical trial documents according to Good Clinical Practices, and ensure inspection-readiness

Persistent inspection readinessWith Documentum for eTMF, inspectors have a dedicated interface that allows them to see the TMF categorized by study, site, or date. Using faceted navigation, the requested documents can be quickly retrieved. The result is quicker responses to audits.

Uncompromised regulatory complianceWith Documentum eTMF, you can clearly demonstrate 21 CFR Part 11 compliance. The solution supports detailed audit trails, access control, distribution and version control, lifecycle management, as well as support for print control services, watermarking, and overlays.

Real-time documentation trackingIt is critical to understand what TMF document is required, what is missing and what is completed. Leveraging visual and interactive dashboard reports, Documentum for eTMF helps users efficiently find and complete missing documents and gain actionable insight into process inefficiencies.

Real-time tracking of document collection is based not only on the trial status, but also on the progress of the countries and sites providing detailed visibility. Automatic quality checks detectmismatches when the wrong document is entered, for instance, or an image is unclear, or a document is missing a sign-off. And metrics reporting provides actionable insight on TMF completeness, timeliness, and quality

The modularity of the DOLSR platform will help you meet your needs

DOLSR CRO is both a full business solution and extendable subset of DOLSRDOLSR is a business solution for organizations in the life science industry. In the basis it is the OpenText Life Sciences industry solution which is a pre-configured instance of Documentum D2.This industry solution contains 4 main modules: eTrial Master File (eTMF) in the clinical domain. Research & Development (R&D) and Submission Store & View (SSV) in the regulatory domain and Quality & Manufacturing in the quality domain.With DOLSR, this quality domain is enhanced with a quality management (QMS) module called EQMS Express. This module leverages the full data model

that comes with the Life Sciences industry solution, reduces the need for a custom integrating with a 3rd party solution and provides all the benefits from the underlying D2 application.

With DOLSR comes the ability to add specific benefits from the Microsoft Office 365 / SharePoint platform.

With Collaborative Edit, DOLSR offers true synchronous editing and reviewing of Microsoft Office documents under control of Documentum but with the flexibility and easy of use that Microsoft offers.

With Collaborative Partner Exchange, DOLSR offers the possibility of working with partners/ customers in a controlled environment without the risk of inserting content that doesn’t meet your quality standards.

With LMS365, DOLSR offers a full Learn Management solution that supports simple TBR tasks up to the full management of role specific curriculums and the certifications that come with it.

When need, it is also possible to integrate DOLSR with the eCTDManager from Extedo.

Why Choose For

Informed Group

Our mission is about building bridges between business processes and users: Connecting People to the Enterprise

Visit www.informedgroup.com for more information about our products and blog posts of our consultants.

Added value is created from experience and educating ourselves during internal research and many conferences.

AIIM Leadership Council EMEA

Young Professional Academy

Informed Group is an active member of the AIIM Leadership Council in EMEA. We value the expertise of AIIM when looking at what the future Intelligent Information Management brings.

With every organization we share the demand for talent. Our approach: hire graduates and learn them our trade based upon our values and experience with practical examples. This academy is open to customers as well.

OpenText Documentum Partner

Microsoft Office 365 Partner

Informed Group is one of the largest OpenText partners in Europe and is the to-go to EMEA partner to implement solutions in the SMB Life Science industry. Integrating Documentum and Office 365 is a speciality.

Informed Group uses Office 365 on its own or in combination with Documentum. And always to support user adoption in scenarios that connects people and enterprise needs.

DOLSR: Our Private Cloud

EIM Products

Documentum was created on the demands of regulated industries: Aviation and Life Science.Its Life Science Solution implements the DIA eDM reference model. DOLSR is the only offer of this industry solution, that is tailored to the needs of SMBs.

Other Enterprise Information Management products available from Informed Group are:Collaborative Partner Exchange, SPA4D, SPA4LS, EQMS Express and the Meta Data Publishing Tool.

In 2006, Informed Group was founded and has ever since helped its customers successfully implement information management solutions based on OpenText Documentum and Microsoft Office 365. Today, we help customers solving their business problems with additional means like OpenText InfoArchive, OpenText AppWorks and OutSystems. We are grateful that we had and have the opportunity to work with customers in a broad range of industries. The knowledge we gained is what we share daily in projects we execute.

Informed GroupVijzelmolenlaan 8b3447 GX WoerdenThe Netherlands

www.informedgroup.com+31 (0)348 342115

jeroen.jansen@informedgroup.com

Tom StaesSales Manager BeLux

Jeroen R. JansenCEO, Owner and Founder

+31 (0) 6 11 31 07 48 +1 (337) 4664 622

tom.staes@informedgroup.com+32 (0) 468 544 916