His presentation will focus on five strategies suited for medical device companies to effectively adopt CDISC Standards. Clinovo has always been a strong proponent of adopting CDISC standards states Ale. We recently held a panel discussion on CDISC for medical device companies and our open source CDISC conversion tool CDISC Express has been downloaded by over 1,000 companies across the globe. In his presentation Ale will explain how to prioritize the different steps to implement CDISC Standards, from CDASH CRF designs to succeeding in an FDA Submission in the SDTM format.
Clinovo's presentation is part of the CDISC Interchange session on Adoption and Evolution of CDISC Standards, chaired by Mark Lambrecht from the SAS Institute. This session will feature a presentation on The Evolution of CDISC Standards and Therapeutic Areas from Tina Apers at Business & Decision Life. Following Ales presentation, Marie-Rose Van-Keer and Véronique Long from the Sanofi Group will talk on Implementation of CDISC-based Global Standards.
Ale Gicqueau founded California-based Contract Research Organization (CRO) Clinovo in 2003. He regularly presents at international conferences on open source, cloud computing technologies, and CDISC standards to streamline clinical trials. Clinovo is a trusted CDISC® Registered Solutions Provider as well as Gold Member of the CDISC organization.
CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The CDISC interchange allows experts from global regulatory agencies, pharmaceutical companies, clinical research organizations, and academia, to speak on current and relevant topics regarding the importance of the use of clinical research data standards.
In June this year, Ale Gicqueau will be kicking-off Clinovos trainings for SAS Programmers to learn to utilize CDISC Express. CDISC Express is Clinovos CDISC Study Data Tabulation Model (SDTM) Mapping Tool. Clinovos free eClinical system answers the growing need to speed up and facilitate the conversion of clinical data into CDISC SDTM standards. The new CDISC Express trainings will cover CDISC Express installation and configuration, mapping definitions and mapping file validation, as well as the creation of the Define.XML. Dates and details are listed at clinovo.com/
Clinovo is a technology focused Contract Research Organization (CRO) headquartered in the Silicon Valley. Clinovo streamlines clinical trials for life science companies globally by developing validated, intuitive open source eClinical Systems. Clients claim over 50% cost savings using Clinovo’s open source Electronic Data Capture (EDC) system ClinCapture, and CDISC Express, the first open source CDISC conversion tool. Services also include Clinical Data Services, Staffing Solutions, and TechTrainings.