For most pharmaceutical companies, submitting clinical study data to the FDA is an expensive and time-consuming process. A study sponsor must collect data from different sources, extract it from proprietary file formats, transform it to conform to CDISC standards, organize metadata describing these transformations, execute validation scripts to ensure data consistency, and convert it all into the file formats required by the FDA for submission.
Unfortunately, the methods used to aggregate, clean, transform, and validate this data today are largely manual, relying on teams of contractors using proprietary software and spreadsheets of transformation and validation rules that are difficult to modify or extend. When the standards are updated, when the validation rules change, if a submission contains an error, or if a company wants to build a data warehouse for all their study data: the entire conversion must be restarted.
The result? A process that is expensive to perform, slow to fix errors, and difficult to maintain.
Join John Keilty, General Manager at Third Rock Ventures, and Timothy Danford, CDISC Solution Lead for Tamr, as they discuss some of the key challenges in preparing clinical trial data for submission to the FDA. Following the presentation, Timothy will offer a demonstration of Tamr and how it provides offers a scalable, replicable way to automatically convert, validate, and package clinical study data in file formats organized according to the latest CDISC standards.
About John Keilty, General Manager, Third Rock Ventures
Prior to joining Third Rock, John was the VP of information technology and informatics at Infinity Pharmaceuticals where he was responsible for information systems, software development, computational science, biostatistics, clinical data management and clinical informatics. Prior to joining Infinity in 2002, John was an early member of Millennium Pharmaceuticals, where was responsible for the creation, management, implementation and transfer of much of the company’s core genomic technologies.
About Timothy Danford, Tamr Inc
Timothy Danford has over a decade of experience in genomics and bioinformatics, having started his career at Massachusetts General Hospital’s MIND Informatics group. Prior to MGH, Timothy was an application architect focused on tactical genomic data integration and visualization projects at Novartis’s Institute for Biomedical Research. Timothy received his PhD in Computer Science and Artificial Intelligence at MIT.