Pharmaceutical and life science companies are faced with new challenges... how to make more efficient use of scarce resources, how to leverage new technologies, and how to ensure that processes remain competitive and value focused.

Participating in the eClinical Forum can help you to better understand and benefit from a wealth of information and expertise on successful implementation of clinical research support across the industry. As technology, processes and data standards continue to evolve and integrate within biopharmaceuticals and healthcare, keeping pace with future trends is essential in improving the efficiency and speed of clinical research and in getting innovative medicines to patients.

Join the eClinical Forum to engage in cross-industry activities that are driving performance, leveraging knowledge and designing the future.

eClinical Forum Events

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Latest eClinical Forum News

eCF Releases several key "Members Only" documents and tools

The eCF is releasing 3 documents to eCF members via the eCF website “Members” area (un/pw required).  Please feel free to download them and share with other members of your company.


·         Draft White Paper:  Electronic Data Capture in Clinical Trials using Service Providers -- A method for ensuring the Investigator’s control of and continuous access to the CRF data reported to the sponsor when using an independent third party. This document is the result of countless hours of work by the eCF EDC Hosting Team and has been peer-reviewed by several industry groups and key opinion leaders. It will be presented/discussed with the EMA on 30-Nov-2015.

·         Checklist for Electronic Data Capture Systems in Clinical Trials using Service Providers -- Tool for assessing the regulatory compliance of an i3P‐hosted EDC system used in clinical trials. This checklist is an outgrowth of work done by the eCF to identify key criteria for systems that provide source data for clinical trials (EHRCR Functional Profile (HL7, ANSI, EuroRec), and “eSRA” eSource Readiness Assessment Tool for clinical research sites. Please note: the eSRA is open to the public and can be accessed via www. Eclinicalnetwork.org)

·         eCF Regulatory Resources Table – This table maps eClinical areas of interest (eg EDC, ePRO, eSubmission, etc) to appropriate regulatory documents from FDA, EMA, PDMA, ICH, other.  The table provides a link to obtaining the document via the internet. This is a working document and will be updated as the eCF REG becomes aware of new documents.



eSRA (eSource Readiness Assessment) Released!

The eClinical Forum has produced an easy online tool for investigative sites to use to assess their healthcare system to determine if they are suitable to originate data that could become part of a clinical trial. eSRA (eSource Readiness Assessment) produces a report that sites can provide to all of their sponsors, thus avoiding the burden of completing different forms for each sponsor. The eSRA template is based on EMA and FDA regulations and guidances and has been reviewed and piloted by many sponsors, CROs, EHRvendors, and Investigative sites. The completed assessment is suitable to be included in eTMF documentation and provided to regulatory authorities. The tool is available FREE to all -- please check it out at: www.eclinicalnetwork.org


Want to know more?... Watch short videos... About eSRA      Training Webinar

 read more ...

2014 Was A Great Year - 2015 Promises to be Even Better!

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:

    Asia Pacific:

    •      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

    North America:

    •      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.

    Kind regards,


    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)



    eCF Meets with EMA GCP Inspectors eSource Group, London, 1st December 2014
    Representatives from the eClinical Forum and members of the EMA GCP Inspectors eSource group met in London 1st December to discuss controls for Electronic Data Capture in Clinical Trials. Discussion allowed the two sides to better understand requirements, current concerns and potential solutions. A White Paper and Checklist developed by the eCF to address compliance concerns was discussed and some initial thoughts for areas of clarification, questions to be addressed, inconsistencies to fix were identified. The eCF will produce an updated document incorporating feedback expected from EMA and FDA inspectors ready for release for review by partners during quarter 1/2 2015. A follow up meeting is proposed for June 2015 with a number of representative stakeholders in this area. 

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