| Although still in its infancy, eClinical represents the next generation in EDC opines David Laky of eResearchTechnology
Just as sponsor organisations began to understand that the ‘silo’ approach – unique solutions for data management, trial management, safety, and so on – to implementing technology to assist clinical trials was failing, electronic data capture (EDC) was being introduced. Sponsor organisations then began to realise that by focusing on all aspects of the clinical trial process they would achieve larger efficiency gains but became distracted by the promises EDC had to offer. In so doing, organisations inadvertently abandoned their unified clinical trial process initiatives. However, the proper choice in an eClinical platform will help put sponsor organisations back on course.
WHAT IS eCLINICAL?
EDC, the concept of collecting data from remote sites via computers, is undergoing an evolution. Back in the latter part of 1996 and early 1997, sponsor organisations began to scrutinise how technology, specifically the internet and the rapid ascent of computing power to the desktop, could lead to the reduction in time and costs associated with conducting clinical trials. It is at this time that EDC was introduced with the promise of ‘cleaner data quicker’. This promise would surely translate into immediate cost savings to all sponsor organisations – or would it?
IN COMES eCLINICAL
eClinical takes the EDC concept to the next logical level yet it is a return to basic fundamentals that existed prior to the EDC revolution. It is a platform of integrated technology, services, and processes that focus on the entire clinical trial process. Unlike EDC, eClinical is not just a reference to technology and functional applications. It includes, but is not limited to, data management, trial management, safety, patient diaries, patient enrolment and management, electronic medical records, data analysis, clinical supplies, and finance.
In order to be successful with eClinical, the processes and procedures surrounding the conduct of a trial must be in synchronisation with the technology used to support the trial. This means that sponsors and their partners – think, for example, of contract/clinical research organisations (CROs) – must share in the responsibility of conducting and supporting a clinical trial. |
