Welcome to Florida & Brussels & the eClinical Forum: ePortals & EMA Compliance

November 11, 2010 John Jordan

Make sure your tray table is in the locked position because we are now off to Brussels and Ft Lauderdale for the eClinical Forum (eCF) fall meetings.  The eCF holds four meetings a year, a Spring and Fall meeting for both the EU and North America.  These meetings are designed by the members of the eCF and that allows for some really good dialogue amongst various clinical trial stakeholders.  A full scope of perspectives are explored as membership to the eCF is open to Pharmaceutical and Biotech Sponsor organizations, as well as service providers (or “Associates” and “Vendors” as we are called by fellow members) such as ePRO, EDC, CRO and other technology providers. 

In both the Brussels and Fort Lauderdale meetings the topic of clinical trial portals, aka ePortals, was front and center.  Several large Pharma organizations have utilized these ePortals within their research and quite a few others are beginning to explore their use with pilot programs.  It was clear that ePortals are not a “fad” and it looks as though their adoption rate will be growing. 

The use of an ePortal is aimed at providing the clinical investigator and other site personnel with a single point of reference for a given study/program/Sponsor.  Typically they are used to provide study documentation, FAQ’s, forms and other information relevant to the study, but they are increasingly being used to provide access to the various systems employed for a study.  Links to the sponsors EDC and ePRO systems are often provided within the ePortal.  Based on the active dialogue at the eCF, the ability to provide a single sign-on for the various systems seems to be the next big obstacle to overcome.

eCF logo powered
Another hot item was the EMA reflection paper on electronic source and the implications it may have on sponsor organizations.  As an ePRO provider, CRF Health feels we remain fully compliant and that was the consensus of the attendees, but the references to Electronic Health Records (EHR) systems and the need for Sponsors to ensure compliance to existing regulations for those systems was an eye opening discussion for many at the Forum.  Can Sponsors be expected to ensure the compliance of these disparate systems?  Is a site qualification questionnaire sufficient in determining compliance?  Should CRA’s or Monitors be expected to make this judgment during their initiation visits?  The eCF is planning their next steps with regards to these questions.  Soon answers to these questions and more should be attainable.

More active discussion occurred around other topics including reduced Source Document Verification (SDV), Serious Adverse Event (SAE) integration, the use of Images in Clinical Trials and an analysis of the findings from the Investigator Site Survey the eCF conducted last year.

I highly recommend membership in the eCF and encourage clinical trial stakeholders to explore having your organization join the Forum.  It is an open environment where members share their experiences, thoughts and visions on the use of eClinical technologies and processes, allowing all members to benefit.  Tell Richard Perkins  and Suzanne Bishop that JJ sent you.

Now, prepare to return your seat backs to their upright position.  In the next blog, we will be off to Minneapolis and the 2010 SCDM Annual Conference.

All the Best,

John Jordan

Helpful Links:

EMA Reflection Paper  

eClinical Forum 

My Santa Says ePRO, ePRO, ePRO Instead of Ho, Ho, Ho!!!
My Santa Says ePRO, ePRO, ePRO Instead of Ho, Ho, Ho!!!

Pharma, CROs, Clinical Trial Industry: Get Closer to Hot ePRO Topics

Pharma, CROs, Clinical Trial Industry, Get Closer to Hot ePRO Topics