Summary

Insmed transforms the lives of patients battling serious rare diseases by developing novel, targeted therapies to help serve the critical unmet needs of these patients. In addition to traditional clinical development, Insmed runs a compassionate care program for unsolicited requests by physicians with patients who don’t have approved treatment options and don’t meet the inclusion criteria for a study. These patient groups receive investigational product where the company doesn’t collect data

The company has routinely received compassionate use requests as traditional Word files, but as requests have increased dramatically over time with pipeline advancements, so did the administrative and time burden supporting a manual paper process for drug supply and accountability.

After positive experiences with Medidata's Rave RTSM (Randomization and Trial Supply Management) on prior phase III studies, Insmed partnered with Medidata to use Rave RTSM to support the clinical investigational product (IP) supply flow from beginning to end across multiple regions. Insmed now has a record of every shipment ever made, and with Rave RTSM the company can predict IP use to avoid waste and search by site to oversee supply.