| |
 |
A UNIQUE GROUP
The Forum was started in 2000, the idea of a group of people who were keen to meet and discuss all aspects of Electronic Data Capture and eClinical. Today, the membership includes over 50 companies from the Pharmaceutical and associated industries. The group is trans-atlantic and is a registered association in France.
We provide a non-profit, non-commercial environment for members of the pharmaceutical and allied industries who are or will be involved in ‘eClinical’ initiatives. By establishing open communication and links between members and stakeholders the group provides the practical information, approach and learning experiences required to maximise the success of eClinical initiatives.
The groups costs are covered through member contributions alone - we don't sell exhibition space, advertising in newsletters, endorse products or engage in other commercial activities. This allows us to freely discuss and investigate any topic of interest to our members. Most eClinical Forum deliverables are made freely available within the public domain.
Workshop and teleconference topics are chosen by the members and have both strategic and operational focus
(see Recent Topics below).
|
 |
|
Read More...
|
 |
|
 |
 |
“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, www.ehrcr.org)
- A presentation on SAE Integration Systems best practices (2009)
- A handbook of criteria to be considered when conducting clinical trials using ePRO (ongoing, 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)
- 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, an new survey to update this info was launched in May 2009)
- 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
eCF Constitution.
A not-for-profit organisation, the eCF is directed by a Steering Committee that is comprised of members who volunteer for a two-year term. The eCF Steering Committee is balanced between members located in the United States and the European Union, as well as equal representation from pharma and associate members. All eCF members have input into topics for meeting and sub-team discussions.
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. While 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 2009 for both Core (pharmaceutical) and Associated members is €7,800 for membership in both the EU and US Forums, or €4,100 for either the EU or US Forum.
Membership in the eClinical Forum provides the following:
- Surveys:
- Knowledge and information:
- Tools:
- Scale up issues and approaches
- RFI development
- A network of eClinical experts
- As part of the membership, all members are given one seat at each of the meetings that are held twice a year in both the EU and the US. In addition, Core members are permitted one extra, complimentary seat at each meeting.
- Access to the website’s Members area
- Member companies can participate in bi-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.
eClinical Forum Membership Form (PDF 100K)
Funding for the forum comes from the annual membership fee set by the Steering Committee.
The forum is non-profit making and non-commercial (we don’t raise any funds from selling products, services, advertising, endorsing products or exhibition space).
The revenue is used for providing services to members (maintenance of the web site, administration, surveys, meetings and other Forum activities).
Membership will give you access to the meetings, teleconferences, cross-industry work-groups, previously completed deliverables, and a powerful network of eClinical specialists around the world.
In addition to our Spring and Autumn meetings in both Europe and the US, the following activities are ongoing:
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 (co-sponsored by eClinical Forum and PhRMA EDC/eSource Task Force) is the first international team working with the HL7 EHR-S Functional Model and is additionally collaborating 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 considered as part of a certification by CCHIT (US Commission for Certification of Healthcare Information Technology). The profile has been approved by EuroRec for inclusion in their EHR repository (Nov 2009) and has been presented to CEN (EU Standards Commission). 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, www.ehrcr.org, or contact any of the co-charis: Linda King (king_linda_s@lilly.com), Catherine Celingant (catherine.celingant@mpi.com), Suzanne Bishop (suzannekbishop@gmail.com), Richard Perkins (richard.perkins@con7.com). This project has a detailed project plan and is actively seeking external funding to continue as it is a long-term project. "Gold Level" funding partners are Eli Lilly and Company, Procter and Gamble, Pfizer, PhRMA and GSK.
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. Workshop sessions were held at both the US and EU 2008 meetings. 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 will be taken externally to appropriate industry meetings in 2009 and 2010. Their aim is to have a de facto best practice standard, plus some suggested steps towards achieving this. The presentation is 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. The handbook was initially released for eCF members only, and is now (Oct 2009) release via the eCF website for public use . It is in the process of being transferred into a "Wiki"-style document, such that industry-collaboration can be ongoing. It is anticipated to be released in the Wiki-style in 4Q 2009 on this website.
Bi-Monthly Teleconference Discussions on Current Topics -- Started in November, 2006, Bi-monthly teleconference discussion sessions (called "Birds of a Feather Sessions") are based on member-submitted discussion topics that focus on issues of current work situations. All members are welcome to submit topics for discussion (submit to suzannekbishop@gmail.com or richard.perkins@con7.com), 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 Board on the Members Area of our website -- members can ask specific questions and get feedback from other members. This will be available with the new Members Area of this website.
Future EHR/eSource Paper – This activity is completed and the resulting paper can be downloaded from the Knowledge Section of our website. Although the paper is now 2 years old, it is still a very relevant discussion on the potential use of EHR systems for gathering information for regulated clinical research. Anyone new to this discussion will find this paper to be extremely helpful in getting jump-started on this topic. The team was comprised of members from the eClinical Forum and PhRMA EDC Task Force. They met weekly for a year to discuss the scenario of using electronic medical records as source for clinical research. In Sept 2006, they released the discussion paper titled "The Future of EHR as eSource for Clinical Research". Articles based on this paper were published in Bio-IT World (January 2007) and Pharmaceutical Executive (Dec 2006). Team members presented the paper at several US and European industry meetings in spring and fall 2006. Presentation was also made to EuroRec and HL-7 Technical Committee. An outgrowth of this effort is the EHR Profile for Clinical Research (see above).
Data Management Metrics Definitions -- A subgroup was formed in 2008 to review definitions of metrics in an effort to encourage industry standards in this area. The group has been given the opportunity to collaborate with the Metrics Champion effort and will continue working with MC in 2009.
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 (as of Oct 2009, we have far exceeded our goal!). Results will be summarized and presented at industry conferences and via our website in 4Q 2009 and 2010.
Recent workshop and telephone conference topics have included:
-
Data transfer considerations, issues, and best practices
-
Future of mobile technologies
-
Leveraging Social Networks for eclinical use
-
eCF-lead Investigator Site Survey – analyzing the results
-
Research and eHealthcare Standards
-
Practical Considerations for using Electronic Health Records for Clinical Research
-
Reducing Source Data Verification through use of technology
-
Key validation issues – is validation holding us back?
-
Integration trends and implications
-
Experiences/lessons learned using CDISC Standards
-
Decision support metrics
-
EDC in Phase 1 trials
-
Trends in Help Desk support
-
Collaboration and training technology trends
-
Decommissioning and Archiving
-
Electronic Trial Master File
-
SAE/AE reconciliation using true integration
-
Medical Information portals and Investigator portals
-
Off-shoring technology and/or data management: best practices
-
EDC in emerging countries: issues, best practices
-
ePRO best practices
-
eCRF Design best practices
-
Changing roles and responsibilities
|
|
|
|
 |
 |
 |
|
|
|
|
|
|
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)
|
 |
|
|
|
|
|
|
|
|
|