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