By Eyal Wultz, President & Co-Founder, and Bremer Louw, Vice President, Biometrics Operations & Business Development, Bioforum
Data capture, analysis, and reporting are critical activities during the clinical trial process, as this information provides clinical researchers with a reliable and high-quality source for validating a product’s successes and failures. Yet, without a standardized method for data collection and, eventually, submission to the regulators, the integrity of the data – and the success of the trial – can be at considerable risk. Recognizing this, the FDA mandated in 2014 that all clinical trials beginning after December 17, 2016, must submit data in a standard supported by the Clinical Data Interchange Standards Consortium (CDISC).1
CDISC’s standard for tabulated clinical data is the Study Data Tabulation Model (SDTM), which provides a standard structure for organizing and formatting data to streamline processes in collection, management, analysis, and reporting.2 However, the increasing complexity of clinical trials and regulatory requirements are posing significant challenges to producing SDTM deliverables within limited timelines and budgets. So, too, is the task of finding and retaining qualified and experienced programming resources. Download the full article to find out how sponsors can ensure SDTM compliance while still maintaining the efficiency and speed necessary to meet their trial timelines and milestones.