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TORONTO, Jan. 20, 2016 /PRNewswire-iReach/ -- McDougall Scientific Ltd., specializing in data management, statistical strategy and analyses for clinical research, will host the first CDISC training ever to be held in Canada. Taking place from May 24 through 27 this year, three courses will show pharmaceutical, biotechnology and CRO (clinical research organization) professionals how to use CDISC standards to comply with the FDA’s landmark guidelines governing electronic submissions. Issued in December 2014, the FDA guidelines state that all studies with start dates of December 2016 and beyond must use FDA-supported standards, formats and terminologies like CDISC for NDA, ANDA and certain BLA submissions. The three courses at McDougall in May SDTM, ADaM and Define-XML address the core components of a CDISC-compliant data submission to the FDA.
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Industry and regulators around the world have embraced the broad standards established by the Clinical Data Interchange Standards Consortium, or CDISC. McDougall sought the opportunity to raise CDISC visibility and promote standards application in Canada by offering training in the country for the first time. “As data specialists, we strongly advocate robust standards to expedite processing, analyzing, exchanging and submitting clinical trial data,” says McDougall’s Vice President John Amrhein. “We’re very proud to be the first Canadian host of training in CDISC standard implementation. These seminal standards are already shortening the drug development life cycle, which in turn drives down development costs.” Amrhein and his team, who note that Toronto ranked seventh on a recent New York Times list of places to go in 2016, will welcome attendees from the United States, Canada and Europe.
The three courses will teach CDISC standards and implementations:
- A two-day course about Study Data Tabulation Model (SDTM) theory and application. SDTM is the most widely adopted CDISC standard.
- A two-day course about implementing the Analysis Data Model (ADaM).
- A one-day course about Define-XML, which is the standard data definition for SDTM and ADaM.
McDougall is deeply involved in the CDISC organization and standards development. McDougall’s Chief Analytics Officer, Hong Chen, MSc, P.Stat., serves on the CDISC Advisory Council (CAC) and the SDTM Validation Team. “Serving as a CAC representative provides a unique opportunity to guide and develop CDISC standards that streamline and improve clinical research through a platform-independent, easily interpreted, understood and navigated data framework across the industry.” The Clinical Data Interchange Standards Consortium is a non-profit organization establishing worldwide industry standards for electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.
About McDougall Scientific Ltd.
Serving North America, McDougall Scientific delivers high-value statistical strategy, analyses and data management for all phases of pharmaceutical, biotech and medical device clinical trials. Clients trust McDougall Scientific for a full range of critical services, establishing long-term partnerships for immediate, tactical and strategic planning and execution. Widely respected for clinical trials expertise and deep experience, the company sets the standards for exceptional value, statistical aptitude and compressing time to market.
Media Contact:Amy Barnett, Influence Media LLC, 267-419-8735, abarnett@influencem.com
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SOURCE McDougall Scientific Ltd.
