Articles
Integrated eClinical Solutions Be Afraid, Be Very Afraid
By Timothy Pratt, PhD
Originally published in PharmaVOICE VIEW on E-Solutions, October 2006
Why are lots of EDC vendors talking about how integrated their systems are? And what's this new buzzword emerging - eClinical? Is this just EDC? Why should you be concerned about an "integrated system" - surely that's a good thing, right? Let's start with a few definitions and move on to discussing the important differences between integrated and homogenous technologies, including the impact to an organization and clinical success.
eClinical has emerged recently as a term used to encompass the shift in clinical studies to electronic computer-assisted capture and management methodologies to increase efficiencies and quality by replacing manual and paperbased systems. Electronic data capture (EDC) is just one component of the eClinical universe, which also includes clinical data management systems (CDMS), clinical trial management systems (CTMS), interactive voice response systems (IVRS), patient reported outcomes (PRO), and so on.
Integrated (Heterogeneous) Systems
Integrated eClinical offerings are comprised of a set of software applications that were usually developed as proprietary standalone applications, and have subsequently been forced to "talk" to each other - that is, to make available what they "know," in whole or in part to the other elements of the system. In computer parlance, these are known as heterogeneous systems - the various software "islands of automation" that make such systems up were never intended or designed at inception to have common knowledge of the data contained within each other island; they were built independently. The islands thus have to have bridges built between them to communicate, which limits data traffic to the design and location of the bridge, not to mention the gridlock encountered if the bridge falls down.
Homogenous Systems
Homogenous eClinical systems differ fundamentally from integrated systems in that they are one entire "thing" and fundamentally consist of entities that share common knowledge of one another's data structures, formats, and source code. There is one underlying software framework and code base that is the engine that drives all the offerings of the system, be it EDC, CDMS, CTMS, IVRS, PRO, and/ or any combination thereof. Because homogenous systems don't have to "discover" the data formats during processing they are significantly more efficient and stable than integrated - heterogeneous systems; this also often reduces the need for future additional supporting software purchases.
Well-designed homogenous systems also tend to have far fewer issues interfacing with other data sources, such as diagnostic devices or financial software, if they are based in open-source code, which, by its nature, can be easily modified and effect interoperability via common transfer protocols.
