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Using EDC System:Benefits, Considerations, and Challenges
March 20, 2012
A Quick Introduction of Merck Serono
� Oldest pharmaceutical company
� Four R&D Hubs, Geneva, Darmstadt, Boston and Beijing
� Focus on oncology, neurodegenerative, fertility, and endocrinology
diseasesdiseases
� Running more than 100 trials each year
� Currently use EDC system (InForm V4.6) for 100% inhouse trials
� Planning to upgrade to V5.x in 2012 to take advantage of new features of
Central Designer and multilingual support.
Using EDC System:Benefits
� Closer to real time data
� Cleaner data
� Instant communication between sponsor and sites
� Easier to review by DMs, CRAs, the Medical Responsible� Easier to review by DMs, CRAs, the Medical Responsible
� Issues identified earlier and remotely by CTL
� Audit trail
� Convenient e-signature
� Less paper and archival need (resource saving)
Lots of paper work need to be done, time All work can be done via internet
instantly:
EDCPaper based
Lots of paper work need to be done, time
consuming:
• Sites fill in p-CRF
• Shipment of p-CRF
• Monitors do SDV on paper basis, and
need additional tracker for SDV status
• Sponsor enters data
• Discrepancies sent back by fax
• Paper statements need to be signed by
PIs
• Lots of paper documents need to be
archived and stored …….
instantly:
• Sites can enter data instantly after visit
occurred
• Monitors do SDV online, easily to track
SDV status
• Sponsor can review data right after
data entered
• Queries sent via internet and can be
seen by site instantly
• e-signature
• Less paper archiving …….
Using EDC System:Benefits
All these lead to:
� Faster database lock
� Better quality overall
Faster to lock trials => Faster to the market => Faster to our patientsFaster to lock trials => Faster to the market => Faster to our patients
Using EDC (InForm V4.6) –How those benefits are achieved:
� Clean and user friendly interface
– Familiar Window like interface
– Uncluttered page-dependent tabs
– Easy to navigate design: by site, by visit, by patient, by eCRF page– Easy to navigate design: by site, by visit, by patient, by eCRF page
– Visualized status of visits, eCRF
– Traffic light
Using EDC (InForm V4.6) –How those benefits are achieved:
� Natural page flow
– Dynamic link
– Convenient Navigation functions
– Cycle/Visit management– Cycle/Visit management
– Repeating of visit, page, or section, controlled by user
Using EDC (InForm V4.6) –How those benefits are achieved:
� Nice data management features
– Candidate queries vs. open queries
– Audit trail
– Lock/Freeze at page level, at patient level– Lock/Freeze at page level, at patient level
– Standard and ad hoc reports
– Listing
– Home page with trial news, announcement, and information
Using EDC (InForm V4.6) –How those benefits are achieved:
� Nice Monitoring features
– Open queries
– Freeze at page level, at patient level
– Listing– Listing
– SDV function
Using EDC (InForm V4.6) –How those benefits are achieved:
� Great programming features
– Library template
– Reusable pages, edit checks
– Powerful VB Scripting to do complex edit checks– Powerful VB Scripting to do complex edit checks
– Output file in xml format, which can be easily edited to achieve high efficiency
in programming
– UMT can be done in several ways, e.g. editing xml file, using template
Using EDC System:Considerations
� Geographical locations
� Size of the trial
� Complexity of the trial
� CRF Design� CRF Design
� Technical skills of site personnel
� Hardware configuration
� Helpdesk support
� Cost
Using EDC System:Considerations
� Geographical locations
– Global vs. regional vs. local
– Cross time zones
– Languages– Languages
– System availability
– System maintenance/downtime windows
� Size of the trial
– Number of trial sites
– Number of patients
– Number of CRF pages
– Number of data points
Using EDC System:Considerations
� Complexity of the trial
– Trial design
– CRF page flow
– Dynamic pages– Dynamic pages
– Visit cycles
� CRF Design
– eCRF page considerations
– Grouping of relevant items
– Standardization of data points
– Modular design
– Reusability of CRF pages, edit checks, listings
– Site user convenience vs. DM convenience
Using EDC System:Considerations
� Technical skills of site personnel
– Training needs
– Support needs
– Acceptance of EDC– Acceptance of EDC
� Hardware configuration
– PC
– Internet (for example, military hospitals)
– Site feasibility test
Using EDC System:Considerations
� Helpdesk support
– 24/7 support
– Turn around time
– Language needs– Language needs
� Cost
– System cost
– Support cost
– Training cost
Quality vs. time vs. cost
Find the balance right for you
Using EDC System:Challenges
� Technical competency
� Technical support
� Training
� Global and local helpdesk� Global and local helpdesk
Using EDC System:Challenges
� Technical competency
– Database developers
– Database administrators
– System validation– System validation
– Database development, testing, production
– UAT
– EDC specialists
– …
Specialists with more specialized skill sets
Using EDC System:Challenges
� Technical support
– System support
– EDC support
– User support– User support
– …
24/7 technical support is needed
Using EDC System:Challenges
� Training
– Site personnel training
– CRAs training
– DM training– DM training
– …
Rigorous training is needed to have a smooth and successful trial
Using EDC System:Challenges
� Global and local helpdesk
– Technical skills
– Language skills
– User experience– User experience
– Issue tracking
– Pattern findings
– …
Good user experience demands well qualified helpdesk personnel
Using EDC System:Summary
EDC system can be best utilized in:
� Multinational
� Multi sites
� Large number of patients� Large number of patients
� Medium to long trial length
� Complex trial design
� With a lot of AEs and queries