Take The Right Approach To Supply Accountability

Supply Accountability is the tracking and management of supply distribution, return and reconciliation/destruction in clinical trials. It covers the entire life-cycle of the investigative product (IP). The FDA lists Supply Accountability compliance as one of the top 5 issues encountered during drug sponsor audits. Improper Supply Accountability can cause painful regulatory audit findings, study complications and delays in study closeout.

The unified Medidata Rave Clinical Cloud is an ideal platform for Drug/Supply Accountability as it already tracks the product by its location as well as by lot/label/ID and subject allocation and dosing. Medidata’s Rave EDC + Rave RTSM solutions unified process is pre-validated, highly flexible and can be significantly streamlined ensuring efficiency, timeliness and accurate data by eliminating the need for separate logs (sometimes done on paper) on multiple systems.