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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
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Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements"
The eClinical Forum is happy to announce the Members-Only release of the “eCF Requirements”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.
The eCF Requirements are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. We have reviewed regulatory documents from the FDA, EMA, PMDA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if data which will become part of a regulated clinical trial are consistent with regulatory requirements.
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Outcome: North America Spring Meeting May 1-3 2018
Our Spring North American meeting was held at Bristol-Myers Squibb in Princeton, New Jersey on 1-3 May 2018. Companies participating were Allergan, Allscripts, Array Bio-Pharma, Astellas, Bioverativ a Sanofi Company, Bristol-Myers Squibb, BSI Business Systems Integration AG, Cenduit, Cerner, CRF Health, CSL Behring, D. Bartley Consulting, eClinical Solutions, Elligo Health Research, Janssen Pharmaceuticals, Medidata, Novartis, Omnicomm, Oracle, Pfizer, Rutgers the State University of NJ, Target Health, Veeva.
Birds-of-a-Feather Discussion: ICH-E6 (R2) and Industry Adoption of RBM
Presenters: Abby Abraham and Ken Light, OmniComm Systems
Open To: Staff from eClinical Forum member companies (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact firstname.lastname@example.org )
Background: eClinical Forum Birds-of-a-Feather sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.