Study Executed in One-Third of the Industry-Average Timeline
In May 2019, one of the largest pharmaceutical companies, with a large diversity of drug product, was overwhelmed with a heavy workload with extremely long timelines. They were insourcing, doing their own work on back-end data management — including the eSource database build at the beginning of a trial through the closeout — and CSR writing. A database build was running two to three months, and last subject last visit (LSLV) to the final clinical study report (CSR) was taking three to four months. Beyond capacity concerns, the bottom line was that they needed their Phase I data results faster in order to make informed downstream decisions sooner.