Thursday, August 29, 2013

Hey Presto! The true value of EDC, ePRO and RTSM unlocked: Part 2

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.

Continuing from my earlier blog on rapid study builds, I’d like to share my thoughts on how unified EDC, ePRO and RTSM can assist in achieving continuous data cleaning and review, achieve instant, real time data consolidation without the pain of integration, enable ad-hoc and interim analyses, bring forward database lock and ultimately accelerate clinical development programs.

Part Two: Why real time data consolidation paves the way towards faster study completion
The need for enterprise level or study-by-study integration between EDC, ePRO and RTSM is common. Large elements of EDC, ePRO and RTSM databases are shared and integrations are simply used to transfer data from a source system to a target system. Such integrations often add weeks to study build timelines at considerable expense and are of limited value unless very well specified and tested. All three applications need to use open standards and architectures in order to transmit data effectively. Even now, CDISC ODM and web service adoption is not universal.

Wouldn’t it be nice if all the hard work, risk, duration and expense of integrating these three core Clinical Data Management (CDM) platforms could be eliminated? Imagine what a unified EDC, ePRO and RTSM solution might deliver through immediate and full data consolidation. And just think about the value of an enhanced user experience achieved through common navigation, notifications and single sign on – wouldn’t those high quality, cost effective sites like to come back to you for your next study?

With a unified solution, end-to-end supply tracking with full accountability can be achieved with up to the minute accuracy without any integration effort, cost or risk. The EDC solution can be used to remind subjects to enter data into ePRO, to attend a rescheduled visit and to take their medications, all with no integration requirement. Subjects are immediately randomized in EDC and ePRO data appears in EDC instantly.

Having continuous data consolidation between these three core CDM applications makes it feasible to continuously review, code and clean this data. An easily configurable, unified CDM solution allows workflows to be quickly constructed at enterprise, TA, sponsor or study levels. For the first time the true potential of EDC can be unleashed, as reviewing and cleaning of data actually takes place within the system so that the status of each field is known. This means that the bucket of clean, usable data gradually fills up, in turn allowing powerful analyses and decision making with very high levels of confidence.

For instance, with such a solution the pain of preparing for an interim analysis with data managers, monitors, sites and even subjects, frantically missing items and cleaning data to meet the deadline is largely eliminated.

Ad-hoc analyses with slicing and dicing across what would have been three separate databases becomes possible so that subtle trends in safety, efficacy and compliance data can be discovered. This enables a truly adaptive design with cost-effective solutions, something we’ve been anticipating for years.

A unified EDC, ePRO and RTSM solution is incredibly powerful. It overcomes all the challenges of integration while opening the door to cutting edge data management processes that ultimately result in accelerated clinical development programs.

In part three of this blog I’ll examine even more benefits of a united solution, focussing on how database lock can be done in a matter of a few days after LPLV. 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.

For an further look into the topic of pros of unifying EDC with RTSM as well as ePRO, check out the article The Importance of ePRO & EDC Integration for the Clinical Trial Environment at CROs NT.

Also, Aris Global has just  launched the new site Total Clinical to focus on the better integration to lead to eClincal.

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