en-USen-GB

 

A NETWORK POWERED BY PEERS

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

If you are logged into your user account then dates and times are shown according to your profile settings for time zone. Otherwise dates and times are shown as GMT. PLEASE CLICK ON THE EVENT DESCRIPTION FOR AN ACCURATE DATE/TIME POSTING.

Latest eClinical Forum News

NEWSWORTHY...
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

    Europe: 

    •      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. 

    New Initiatives Started

    The Autumn meetings provided the opportunity to explore regulatory and technology trends, to discuss the status of ongoing projects and to prioritise new initiatives.

    As a result the group are setting up project teams to:

    - Develop and run a follow up of the Investigational Site Surveys conducted in 2004 and 2009.
    - Pilot a process for conducting shared audits
    - Progress new areas for operationalising Risk-Based Monitoring

    Our thanks go to the member organisations whose energy and transparency enable us all to leverage shared knowledge and drive the development of innovative solutions.

     

    eClinical Forum Runs Its First Meeting in Asia

    The eClinical Forum in Asia met on 20-21 May 2014 in Singapore. The meeting provided the opportunity to explore technology, process and regulatory issues and trends and to showcase the ongoing work of the eClinical Forum. This was the first of several planned events and allowed us to discuss the eClinical Forum philosophies and their fit with the needs and expectations of the eClinical community in Asia.

    Our thank you goes to the  participants at this first meeting and to the support that was provided in Singapore all of whom contributed to making this meeting such a success and a pleasure to be involved in.

     

    Not a member?
    Visit the Membership page to learn 
    How To Become a Member

    (Join the eClinical Forum and learn how to leverage existing and
    emerging technologies for electronic clinical trials. Access an
    eClinical community, member-only knowledge, events and forums)