Using EDC System: Benefits, Considerations, and Challenges. March 20, 2012

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Wilfrid Stevenson
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1 Benefits, Considerations, and Challenges March 20, 2012

2 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 diseases 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.

3 Benefits Closer to real time data Cleaner data Instant communication between sponsor and sites 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)

4 Paper based EDC 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. All work can be done via internet 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.

5 Benefits All these lead to: Faster database lock Better quality overall Faster to lock trials => Faster to the market => Faster to our patients

6 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 Visualized status of visits, ecrf Traffic light

8 Using EDC (InForm V4.6) How those benefits are achieved: Natural page flow Dynamic link Convenient Navigation functions Cycle/Visit management Repeating of visit, page, or section, controlled by user

9 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 Standard and ad hoc reports Listing Home page with trial news, announcement, and information

10 Using EDC (InForm V4.6) How those benefits are achieved: Nice Monitoring features Open queries Freeze at page level, at patient level Listing SDV function

11 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 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

12 Considerations Geographical locations Size of the trial Complexity of the trial CRF Design Technical skills of site personnel Hardware configuration Helpdesk support Cost

13 Considerations Geographical locations Global vs. regional vs. local Cross time zones 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

14 Considerations Complexity of the trial Trial design CRF page flow 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

15 Considerations Technical skills of site personnel Training needs Support needs Acceptance of EDC Hardware configuration PC Internet (for example, military hospitals) Site feasibility test

16 Considerations Helpdesk support Cost 24/7 support Turn around time Language needs System cost Support cost Training cost Quality vs. time vs. cost Find the balance right for you

17 Challenges Technical competency Technical support Training Global and local helpdesk

18 Challenges Technical competency Database developers Database administrators System validation Database development, testing, production UAT EDC specialists Specialists with more specialized skill sets

19 Challenges Technical support System support EDC support User support 24/7 technical support is needed

20 Challenges Training Site personnel training CRAs training DM training Rigorous training is needed to have a smooth and successful trial

21 Challenges Global and local helpdesk Technical skills Language skills User experience Issue tracking Pattern findings Good user experience demands well qualified helpdesk personnel

22 Summary EDC system can be best utilized in: Multinational Multi sites Large number of patients Medium to long trial length Complex trial design With a lot of AEs and queries

InForm Functionality Reference Manual for Sites. Version 1.0

InForm Functionality Reference Manual for Sites Version 1.0 1-Mar-2012 2012 by Merck & Co., Inc., Whitehouse Station, New Jersey, USA All Rights Reserved No part of this book may be reproduced in any form