CASE STUDY: Oncology trial

Situation:  A Clinical Research Organization, working alongside a U.S. biotechnology company, wished to set up an 18-country trial for a novel oncology drug. Although they had suggested a branded comparator, Pharmarama knew this drug was to be withdrawn and availability over the period of the trial would be poor.

Action:  Pharmarama immediately located an EU based, FDA inspected, MHRA inspected, GMP manufacturer with EU Marketing Authorization for their generic product. After confirming the manufacturer’s qualifications, capabilities and availability, Pharmarama suggested a program to the client. Working with both the U.S. biotechnology company and the CRO in a tripartite agreement, Pharmarama rapidly set up a manufacturing agreement for 40,000 vials.

Results:  Samples, planned conference calls and documentation transfer, all coordinated by Pharmarama, resulted in the exact single batch product, produced in a custom format. At the same time Pharmarama produced 13 local language PiLs and SPC and the kit packaging, all approved by the client, saving them weeks of labor.