"This is the best use of my time to remain current with what is going on in the industry."
WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
Conducting decentralized trials is an important pathway to improving patient centricity, yet they create painful data management challenges that increase costs and delay access to reliable data. As companies move toward digital trials, the number and variety of data sources grows, and visibility into your data declines. Most modern trial designs, including adaptive trials, need interim analyses which require timely access to reliable data. In this technology showcase, Veeva will share their clinical database, Veeva CDB, and demonstrate how it produces a complete and concurrent view of the clinical data. Decentralized trials run better with centralized data management that can speed database locks and support better decision-making during study conduct.
eCF Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors.
This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing challenges Sponsor companies are having evaluating, monitoring and documenting a site’s eISF, and to share best practices, challenges, and ideas.
Facilitators: Ronit Elstein (Pfizer, US) Martijn Griep (Janssen, Belgium)
A lot has happened in electronic support for clinical research in the last 20 years ... and eClinical Forum has been there discussing it all! We are pleased to be celebrating our 20th anniversary year, stronger than ever with 45+ member companies (and growing), meetings on 3 continents, global webinars that have been attended by members in over 25 countries, very active project teams, meetings with regulators, and freely adding to the knowledge base of the industry. Any organization working in this space is welcome to join. Please see the membership tab on our website (www.eclinicalforum.org) or contact us for more information! email@example.com
As there are no regulatory detailed expectations on oversight by investigators on eCOA data, multiple approaches have been adopted across the industry (from log-in as evidence to notification/alerts or investigator signature on eCOA data). In general, as per other data sources, oversight for eCOA data should be continual and not once at the end of the study. In addition, oversight activities should be right-sized according to the criticality of the data and protocol requirements for compliance. Evidence of the oversight should be available during the conduct of the trial and enduring for the entire retention period. The aim of this webinar is to allow participants to share different approaches and any knowledge of current expectations by regulatory inspectors.
This meeting is being replaced with a Virtual Global Workshop on 11-13 May 2020.
Networking with peers has never been more important in order to stay current, collaborate on shared challenges and influence the future. The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives.
For more information on our Virtual Global Workshop, please contact firstname.lastname@example.org.
North America: Oct 2-4 in Philadelphia, Pennsylvania USA hosted by CRF Health
Europe: Oct 23-25 in Paris, France hosted by Servier
Asia Pacific: Nov 5-6 in Tokyo Japan
Agendas will be decided a few months prior. For more information or to suggest agenda topics, please contact email@example.com
We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent Application for eICF. Some good discussion helped us to understand the business opportunities and value. Materials are available for download. Expand the article to read more about the event.
The meeting this week (Oct 24-26), hosted by Clinical Ink at Normandy Farms, was truly outstanding. With 31 different organizations participating, including guests from 3 investigator sites and a Patient Advocacy group, and members from large pharma, bio-pharma, CRO, and software vendors, the discussions took on many levels and perspectives. We took on issues with new technologies, innovation, patient-centricity, and site processes and technologies, all living under the umbrella of regulations and privacy laws. We also tackled a team-building cooking adventure and did a lot of networking! Our meeting numbers continue to grow with this being the largest meeting for the NA eCF Forum yet, and the post-meeting evaluations consistently show that members appreciate the candor of sharing of information and breadth of topics provided.
The eClinical Forum is a "Network Powered by Peers" and our workshops offer a unique balance of detail and vision, learning and cooperation, ideas creation and innovation. Meetings have always achieved near perfect ratings from members and the workshop in Basel 10-12 October 2016 was no exception. Our largest European meeting yet and one of the highest scoring! Expand the article to see member feedback and the topics discussed.
The eClinical Forum holds several workshops/year, typically hosted at one of the member sites. Our Autumn 2013 European meeting is being hosted by ICON at their offices in Dublin, Ireland on Sept 18-20.
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eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.
We will be discussing a recent eCF/EUCROF positions paper:
The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper. You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)
eCF Round-table: Electronic Investigator Site Files (eISF)
eCF Technology Showcase: Veeva CDB - Creating a Foundation for Digital Trial Data / Decentralized Trials