2014 was another great year for the eClinical Forum thanks to the active participation, drive and openness of its members. We have had ever increasing exposure with clinical research stakeholder groups, regulatory authorities and industry associations. Our non-commercial philosophy and openness in sharing of expertise, visions and strategies has really captured people's attention... and we have shared a lot!
Our earlier work on Risk-based Monitoring has provided a platform for our members to build upon and has provided a reference that several groups have leveraged during 2014. Our insightful work to develop a checklist for GCP compliance of systems (work that started in 2009 with the support of HL7 and EuroRec), has opened up opportunities that have been exploited during 2014. Examples include the eSRA (eSource Readiness Assessment) and EDC Hosting projects that will reach fruition during 2015. Our engagement with EHR4CR has helped us to increase the group’s exposure and has demonstrated the breadth of our thinking and capabilities. We responded to the demand for participation in Asia by running a first very successful meeting in Singapore for participants from the Asia Pacific region.
We are seen as a non-commercial body that can represent a wide range of clinical research interests within industry, healthcare and academia. This has allowed us to play a role in defining the ‘how tos’ of regulatory compliance and to expand our partnerships with like-minded associations and interest groups. But with this growing interest in the work of the eClinical Forum comes new challenges. With the endorsement of our visions and strategies come expectations for implementation. The eClinical Forum has been the victim of its own success! We need to find an appropriate mechanism to ensure that we can move ground-breaking ideas into supported implementations for the benefit of the clinical research community. During 2015 we will get to grips with this challenge as a group.
At the same time we will progress our ongoing projects while initiating new priority initiatives.
Some of our expectations for 2015 are:
Release of the first version of our eSource Readiness Assessment tool (eSRA). In parallel we will start development work on a more interactive version for Release 2. This represents one of several services that we plan to be available through our eClinical Network.
Our white paper on ‘Controls for Electronic Data Capture in Clinical Trials‘ will be sent for review with our partner organisations in preparation for a meeting with regulators mid- 2015 prior to finalising a version for public release.
The Risk-based Monitoring group is extending work on operationalising RBM.
A collaborative effort to conduct shared vendor audits will be implemented.
We will conduct a new investigational site survey in order to better understand the needs and expectations of sites.
Our involvement in the EHR4CR project on re-use of electronic health records for clinical research will extend into the deployment phase during 2015.
We have had to make some small changes for 2015 to reflect our need to embrace a new Asia Pacific Forum that will also now meet 2 times a year. With these changes, membership of the eClinical Forum offers even greater business value for its members.
Our program of meetings for 2015 is being defined:
• Bangalore, India 5-6 February 2015. Hosted by Algorithm Informatics
• Singapore, August/September 2015
• Siena, Italy 28-30 April 2015. Hosted by Novartis Vaccines
• Basel, Switzerland October 2015
• Philadelphia, 19-21 May 2015. Hosted by ICON
• New York, October 2015. Hosted by MediData
We will continue to offer about 9 webinars / telecons on shared topics of interest. These are offered for free to members and have proved to be immensely popular (often attracting 50-100 global participants from member companies).
Finally, we would like to pass on our best wishes to you all for a healthy and prosperous 2015.
eClinical Forum Steering Committee:
Begona Gonzalez (Eli Lilly)
Steven Hughes (BI)
Selina Sibbald (Quintiles)
Richard Perkins (eCF)
Sohaib Khawaja (eCF)
Patrick Nadolny (Allergan)
Julie Brothers (Array BioPharma)
Ed Seguine (Clinical Ink)
Suzanne Bishop (eCF)