“This is the only group worth participating in.”
"This group's focus on cross-functional, cross-company interaction is very forward thinking and truly makes it a working group.”
"The meeting convinced me that membership is valuable."
“As a new-comer, some topics discussed were eye-and-mind-opening.”
"It's invaluable for networking & info exchange"
"Stimulates exchange of experience and knowledge"
"More fun, more creative, more innovative then other groups"
"The best way to exchange experience and to network"
"Stimulating meetings to discuss issues, trends and the future in a company-neutral setting"
"Honest, focused, and interactive"
“Good, open, friendly and not based on politics or presenter agendas.”
"Really good opportunity to share knowledge. I really appreciated the openness of the participants."
"Most motivating and inspiring meeting I attend. Always good "food for thought"."
"Always informative and a great networking experience. Great to see real actions and deliverables from the forum."
"Its such a nice feeling to be in the company of a forward thinking people excited about improving our eClinical lives :)"
“An excellent forum for networking and experience exchange. Hearing how users in similar environments are working with the same types of issues and challenges gave me practical information on what to implement back home.”
"
A well-balanced and knowledeable forum working to share experiences and positively impact the industry."
We have been working to achieve our goals by developing and conducting surveys, developing tools, building a knowledge base of information relevant to the successful implementation of eClinical and building relationships with other organisations and influential groups. We have been working extensively with regulators and healthcare organisations on the environment for clinical research technologies and electronic medical records.
Some of our many activities include:
- A project to identify conformance requirements for information systems providing data being used in clinical research (ongoing, many deliverables, see link on our home page to the EHRCR project)
- A presentation on SAE Integration Systems best practices (2009), which is continuing to put together an industry guide for SAE best practices (ongoing)
- An 800 investigator global survey into investigational site experiences and expectations. The survey investigated local facilities, current experience with EDC and the level of satisfaction, future expectations (public domain, 2001, a new survey to update this info concluded at end 2009 -- analysis of this information presented at industry meetings in 2010.)
- A handbook of criteria to be considered when conducting clinical trials using ePRO (improvements ongoing, initial delivery in 2007)
- A survey of EDC performance (member domain)
- A discussion document (currently in its second version) exploring the future landscape for conducting electronic clinical trials (public domain 2006)
- A glossary of terms used in the eHealth arena (public domain 2006)
- A survey involving 16 companies and performance data from 54 trials past First Patient In and 34 trials past Database Lock, provided a dataset to assess the suitability of selected metrics as candidates for benchmarks and produced a first set of data to quantify EDC performance (public domain, 2004)
- Consolidation of member experience and expectations has allowed the development of a Scale Up Handbook to assist in the identification and management of risks associated with EDC implementation (member domain)
- A decision tree for development of RFI’s (member domain)
- Regulatory information and how to achieve compliance has been consolidated for members and was being supplemented with a survey on company experiences with submission of EDC trials. (member domain)
The Forum is owned by the members and is run by a Steering Committee elected by the members. The steering committee talk monthly in order to:
- Provide leadership and direction and to ensure achievement of goals
- Define policy
- Manage Forum operations and finances (including reviewing and approving the agendas and plans for meetings)
Meetings of the members are held twice yearly in Europe and twice in the United States. Meetings are usually held in the premises of a “hosting member company” but occasionally we have to use external premises. The meetings are very flexible and designed to meet the requirements of members. So each meeting is unique, is very interactive, focuses on practical issues and future strategy and provides the opportunity for networking and experience exchange.
The membership decide upon the projects the group will work on and provide the resources for development of the deliverables. Most deliverables are available in the public domain (sometimes after a period of exclusivity for the membership)
There is nothing else quite like the eClinical Forum.
The eClinical Forum was formed to serve those members of the pharmaceutical industry who are or will be involved in handling electronic clinical research data and related initiatives. Information on the organisation and operation of the Forum can be found in the eClinical Forum Constitution from the 'content links' on the right.
Membership Options
The eClinical Forum has both Core and Associate members. Core members of the Forum are limited to pharmaceutical industry representatives only. Other interested groups (CROs, Vendors, Consulting companies, Conference organisers, third party EDC service providers, Regulators, Investigators, etc.) may participate as Associate members.
Membership of the eClinical Forum includes pharmaceutical and associate members in Europe and the US. Since the eCF is a not-for-profit association, all members share in the operating budget expenses via an annual membership fee. The per-company membership fee for 2012 for both Core (pharmaceutical) and Associated members is €9,630/$13,160 for membership in both the EU and US Forums, or €4,820/$6,580 for either the EU or US Forum.
Membership in the eClinical Forum provides the following:
- A network of eClinical experts
- As part of the membership, all members are given one seat at each of the meetings (depending on member type described above) (2 in EU; 2 in US). Core members are offered complimentary seats for additional meetings as room allows.
- Access to the website’s Members area, which allows for access to:
- Surveys:
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Industry status and future trends
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Investigational site experiences and expectations
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Regulatory experience
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Performance reports
- Knowledge and information:
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The Regulatory environment for electronic clinical research records
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Metrics, cost:benefit analyses
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eSource news
- Tools:
- Scale up issues and approaches
- RFI development
- Member companies can participate in monthly teleconferences which are focused on a particular topic and provide facilitated discussion. Any number of participants from a member company are allowed as part of the annual membership fee.
- Participation in the members-only online discussion forum. Members pose questions to each other and share ideas and experiences in a non-commercial, non-competitive "think tank" type environment.
- Participation in the many ongoing working sub-groups. These groups collaborate on items such as best practices, surveys, responses to regulatory drafts, etc. The sub-groups typically produce a product. Any number of people from a member company can participate in the sub-groups.
In addition to our Spring and Autumn meetings in both Europe and the US, the following subgroup activities are current and ongoing. Many of these are accepting new participants. Anyone from an eCF Member company wishing to join one of these initiatives should contact info@eclinicalforum.com.
Innovative Medicines Initiative – The eClinical Forum participates in the EHR4CR (Electronic Health Records for Clinical Research) project. This project was initiated in March 2011. IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA.
EHR Profile for Clinical Research – The Electronic Health Records for Clinical Research (EHRCR) Profile team has produced a minimal set of functions and criteria needed in order for EHR systems to be qualified for use as a source of data for clinical research. The EHRCR Profile team is the first international team working with the HL7 EHR-S Functional Model, and has additionally collaborated with EuroRec as well as clinical research and healthcare groups. The team has taken an in-depth look at the HL7 and EuroRec functions and defined additional functions (based on clinical research regulations) that are needed for clinical research. The resulting profile has been balloted and approved as an HL7 Normative Standard (May 2008, Jan 2009) and and ANSI Standard (American National Standards Institute, 20-July-09) as well as being used as a resource by CCHIT (US Commission for Certification of Healthcare Information Technology) when developing their CCHIT EHR CR Certification (2011). The profile has been approved by EuroRec for inclusion in their EHR repository (Nov 2009) and has been presented for consideration to CEN (EU Standards Commission) and ISO (International Standards Org) (2011). A new ISO work group which includes participants from several SDOs is being initiated in 2012 to take it forward to that level. In addition to the profile, the group has recently released a white paper detailing what investigator sites should consider in using their EHR systems to supply source for clinical trials. The core group consists of very active participants from the pharmaceutical industry, EHR vendors and clinical research technology vendors and FDA, and participate in discussions with European regulatory organizations as well as European EHR certification authority EuroRec. For more information or to review deliverables from this project team, please see our project website (EHRCR) via the link from the eCF homepage. This project has a detailed project plan and is actively seeking external funding to continue as it is a long-term project. Funding partners have included Eli Lilly and Company, Procter and Gamble, Pfizer, PhRMA and GSK as well as others.
SAE / AE Best Practices – As an outgrowth of a very popular Birds-of-a-Feather teleconference on the topic of SAE and AE best eclinical practices, this team was formed to continue and summarize the discussions. The team has combined the experience of all our members into a presentation on the various methods of collecting SAEs in an eCRF. This presentation has been given at various industry venues during 2010. Currently the group is working towards producing a best practices guideline that could be released into the public domain. Their aim is to have a de facto best practice standard, plus some suggested steps towards achieving this. Materials from this group are available on the Members section of this website.
ePRO Handbook – This team is comprised of eCF members from the US and EU with the goal to develop a handbook to help organizations get started with ePRO. Sections of the handbook were worked on during workshops at several eClinical Forum meetings. In Oct 2009, this handbook was released via the eCF website for public use . In addition, information from the eCF ePRO handbook were used as reference by the ACDM ePRO group in producing their handbook. In 2011 this subgroup was re-formed to update the ePRO Handbook with current best practices and information. The new-and-improved version is anticipated to be released to eCF members in 2012.
Electronic Trial Master File -- This subgroup formed in 3Q 2011 to discuss current best practices and make recommendations regarding eTMF. The group is comprised of members from bio-pharma companies, CROs and software vendors.
eSource -- This subgroup formed in January 2011 to evaluate current regulatory documents and make recommendations to eCF members as well as to respond to regulators with comments on draft and existing documents. The team is comprised of members from bio-pharma, CRO, and software vendors (including ehr vendor). The FDA Guidance on Electronic Source Draft was evaluated and comments submitted to the FDA. The EMA eSource Reflection paper is currently under evaluation. The subteam hosted a workshop at the Autumn 2011 eCF meetings on investigator site assessment with the goal of producing a generic site assessment tool that could be used by all members. This work will continue with the Spring 2012 workshops.
Reduced Source Data Verification -- this subgroup was launched in Spring 2011 following a successful workshop on this topic at the eCF spring meetings. The subgroup goal is to identify current and best practices towards reducing source data verification.
Investigator Portal Project Managers Common Interest Group -- this subgroup formed in 2Q 2011 and is open to Investigator Portal Project Managers.
Monthly Teleconference or Webinar Discussions on Current Topics -- Started in November 2006 as Bi-monthly teleconference discussion sessions (called "Birds of a Feather Sessions"), these are now offered monthly to members at no additional cost. The telecons are based on member-submitted discussion topics that focus on issues of current work situations. All members are welcome to submit topics for discussion, to facilitate discussions and/or to attend any teleconference meeting. These Discussion Sessions / Webinars are free to all members, and member companies can have any number of participants.
Discussion Forum -- Via a members-only Linkedin group called "eClinical Forum", members can ask specific questions and get feedback from other members. Members appreciate this forum as the conversation is through trusted and known peers and follows the same eClinical Forum rules on non-commercial and non-promotion.
Investigator Site EDC Survey -- The eClinical Forum did a comprehensive survey of investigator site's usage of EDC systems in 2001 (summary results are available for download on this website). Since then there has been much discussion of producing comparison results. A new online survey, based on the original 2001 survey, was initiated in June 2009 with a target goal of 500 investigator responses and concluded at the end of 2009 with 800 responses. Results were analyzed and summarized and used for members-only purposes in 2010 and 2011. An overview of the results were presented at industry conferences and via our website in 2010.
Recent workshop and telephone conference topics have included:
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Electronic trial master file
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Interactive response technologies in clinical trials
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Data transfer considerations, issues, and best practices
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Future of mobile technologies
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Leveraging Social Networks for eclinical use
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eCF-lead Investigator Site Survey – analyzing the results
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Research and eHealthcare Standards
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Practical Considerations for using Electronic Health Records for Clinical Research
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Reducing Source Data Verification through use of technology
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Key validation issues – is validation holding us back?
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Integration trends and implications
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Experiences/lessons learned using CDISC Standards
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Decision support metrics
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EDC in Phase 1 trials
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Trends in Help Desk support
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Collaboration and training technology trends
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Decommissioning and Archiving
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Electronic Trial Master File
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SAE/AE reconciliation using true integration
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Medical Information portals and Investigator portals
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Off-shoring technology and/or data management: best practices
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EDC in emerging countries: issues, best practices
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ePRO best practices
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eCRF Design best practices
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Changing roles and responsibilities
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ePortals
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CDISC Experiences
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EMA eSource Reflection Paper; FDA Draft eSource Guidance