Case Studies

From Phase 1 to NDA and Beyond

StatWorks began as a consultancy with one Phase I project that was awarded by a former colleague who had joined a small biotech company. Over the next seven years, StatWorks remained as the statistics partner for this company. We completed over ten studies, compiling an NDA, an EMEA submission, a Japanese submission, and converted the NDA to a CTD format. We continue to support this compound's development as a marketed product within a multinational pharmaceutical company.

Regulatory Submissions

Over the last several years, StatWorks has assisted customers in preparation of their regulatory submissions. We've provided lead support on creation of integrated ISS datasets. We've created CDISC SDTM datasets and supporting dataset documentation. We've responded to FDA questions and provided ad hoc analytical support for regulatory support.

To The Rescue

A few years ago, StatWorks was asked if we could take over the data management and statistical analysis of a device trial for a large medical device company. First we audited the clinical data and determined quality was so poor that all parties agreed to start over. We re-entered all the data, closed and locked the database, produced tables/listings/figures for a PMA submission and assisted in PMA defense. The device was approved and we continue to support a long-term registry for this device.

EDC Support

We regularly assist customers in reviewing the setup of their EDC systems to ensure the study data can be integrated and used to produce the expected statistical analysis.

Quality Control

We assisted a biotech company in performing quality assurance of another statistical group's output. We located significant issues with the data analysis and assisted the customer in troubleshooting the data and analytical issues.