Today's post comes from Simon Wilson, Subject Matter Expert, Clinical, ArisGlobal. Simon started his career in clinical research at a site and lab level before progressing though data management, clinical operations, clinical technology and process implementation leadership posts at Bayer, PAREXEL and CSL. Over 15 years’ experience in head office and affiliate Pharma and CRO settings have provided Simon with a thorough understanding of this topic. Simon has a keen interest and expertise in unlocking the potential of eClinical applications.
I’ve been attending conferences and vendor user group meetings for some time now and getting more and more frustrated with aspirations - yes, aspirations - of building a study across EDC, ePRO and RTSM in less than three months and then locking it within a month of last subject last visit.
Why, I ask myself, in 2013 is it still so painful and costly to get even simple studies off the ground across these applications? And why, with millions of dollars spent on technology and process enhancement, can I still not cut and analyze my data at will? Any why, with so much experience, can leading CROs or sponsors still not lock a study within days of the last subject completing the study?
There are many answers to these questions but a rather simple solution. In this series of three blogs I’ll outline how a unified EDC, ePRO and RTSM solution answers so many Clinical Research prayers.
Part One: How to build a study in EDC, ePRO and RTSM in a few weeks
If we take an EDC build in isolation, it often takes two or three months from final protocol to go live. While these durations can be reduced by using now-commonplace interactive spec/build/review cycles, most EDC systems require the programmer to have significant training and expertise. An EDC platform with simple drag-and-drop form, dynamics and calculations build - capabilities allows the designer to see the form and validation check output as its being built. This saves weeks of study build time and requires significantly less resources. Add to this easily configurable, study or URL-level configurations and notifications, and even more time, labor and expense is saved.
But this is just one element of the study. Even now, if EDC is to be used alongside ePRO and/or RTSM, builds in each system need to be staggered - interdependencies between the design of ePRO and RTSM elements mean that progress towards go-live is limited by the speed of the slowest development. Very often, this approach will involve three vendors with disparate processes and review cycles, communication issues and complex vendor management and governance.
OK, so the builds are done. Now it’s time to integrate EDC with ePRO and RTSM. Even with standardization and repeated use of the same solutions, this is never simple. Added to that, even with CDISC standards, definitions of context, e.g., site, country and region can differ between the three systems, so the value of data exchanged is limited.
Now, we’re ready to go live, but we still need to create sites, user accounts and provide training in the three systems – more time and effort…
So, what if the easy build technology I’ve described for EDC was available in ePRO and RTSM also?
Wouldn’t it be nice if the three systems were all built on the same database, so the need for integration and loss of context vanishes?
And how about doing away with duplicated site and user management, three sets of logins, three sets of training and three ways in which to navigate around these core applications? Imagine how sweetly that would go down with site users.
For some time now, vendors have been collaborating with each other and even converging, say RTSM with EDC, so that many of these issues have started to be addressed. But a genuinely unified EDC, ePRO and RTSM solution – one solution, built on one set of data structures and one architecture that surfaces three modules—represents the seismic shift that Clinical Development has been waiting for, to finally realize the potential of Clinical Data Management technologies.
A fully configurable, unified EDC, ePRO and RTSM platform in which studies are easily built can shave many weeks off study build time, achieve instant and full data consolidation with zero effort and eliminate duplicated site and user administration and training.
In parts two and three of this blog I’ll examine further benefits of a united solution. To learn more about realizing the dream, register to join us for a webcast on Wednesday, September 25 at 1:00PM EST or 10:00AM BST.
Click here to see the web seminar abstract form.
More about the web seminar:
Web Seminar: Realizing the future today: how unifying EDC, ePRO and RTSM is no longer a dream
The use of electronic data capture (EDC) has become widespread in recent years. Following regulatory guidance, the adoption of electronic patient reported outcome (ePRO) systems has increased and there is already common use of randomization and trial supply management (RTSM) platforms.
Sponsors tend to select individual EDC, ePRO and RTSM applications at a study or enterprise level based upon cost and functionality. To truly realize the benefits of these applications, they need to be fully integrated. These integrations need to be carefully specified, programmed and tested. Since the data flows achieved by these integrations are highly study specific, they need to be built study-by-study, adding time to EDC, ePRO and RTSM study builds. Consequently, it often takes in excess of three months for these builds and integrations to be completed, placing a considerable financial burden on each study.
The need for these integrations remains since very few vendors can offer a full suite of eClinical applications. For many of those that do, they have arrived at this point through a series of acquisitions. Large elements of EDC, ePRO and RTSM databases are common and the integrations are simply used to transfer data from the source system to the target system. Rather than fixing a problem of disparate applications, why not build a unified platform, elements of which can be surfaced in EDC, ePRO and RTSM applications?
Attend the webinar and learn how a unified solution is a new approach that can significantly improve study build times and mitigates the problems associated with managing multiple integrations. Register to join us for a webcast on Wednesday, September 25 at 1:00PM EST or 10:00AM BST.
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