SDTM in Real Time, A Case Study: Initial Datasets by First Patient In; Final Datasets Within 24 Hours of Study Lock

Last year’s renewal of the PDUFA act indicates that the FDA will require all submissions to include the clinical data in a standard format, within approximately 3 years. This standard is assumed to be the Study Data Tabulation Model (SDTM) maintained by CDISC.

Alkermes has been producing standardized SDTM datasets using OmniComm’s Export Utility for regulatory submissions within their Electronic Data Capture system over the past 2 years.

This webinar will:

• Cover mapping SDTM specifications during study design and also will describe the benefits of having an SDTM database available during study conduct and having the final datasets within 24 hours of database lock
• Provide a brief overview of the technology that provides these capabilities

Speakers

Keith Howells, SVP Development, OmniComm Systems, Inc

Keith Howells is an executive with 20 years’ experience in the application of Information Technology to the drug development process. As Senior Vice President of Development at OmniComm, he is responsible for product innovation for the TrialMaster and eClinical suites. Previously, as Senior VP of Development for Medidata Solutions, he helped to catapult Medidata Rave from relative obscurity to being one of the most widely adopted EDC systems in the industry. Prior to that, he played a major role in establishing Oracle’s Pharmaceutical application business, initially as director of consulting for Oracle Clinical and then as VP of Development.

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Prashanthi Vunnava, Senior SAS Programmer, Alkermes, Plc.

Prashanthi Vunnava has been in the Pharmaceutical industry for 6 years. As Senior SAS Programmer she is mainly responsible for creating CDISC SDTM, ADaM & Define documents for FDA electronic submissions and also providing oversight into data management activities like data cleaning, building CRF and edit checks. Previously worked as contract Senior SAS Programmer for big Pharmaceutical companies like Bristol Myers Squibb, Amgen and Pfizer where she was responsible for creating Non Linear mixed Effect Model (NONMEM) datasets for Pharmacokinetic Modeling Scientists from all therapeutic areas. Prior to that, worked as Research Associate for 5 years at Wayne State University funded by National Institute of Neurological Disorders and Stroke grant which led to contribution of research publications in top notch peer reviewed scientific journals.

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