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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.
AGENDA AVAILABLE: eClinical Forum Europe Meeting in Paris, France 23-25 October 2018
Our next meeting of the eClinical Forum Europe will take place in Paris, 23-25 October 2018 and is kindly hosted by Servier. An outline agenda and registration details are available...
AGENDA AVAILABLE: eClinical Forum Asia-Pacific 2018 Workshop in Tokyo, 5-6 November 2018
Our next meeting of the eClinical Forum Asia-Pacific will take place in Tokyo, 5-6 November 2018 and is kindly hosted by Boehringer Ingelheim - Japan. An outline agenda and registration details are available...