Pharmacovigilance Management Services

The Cell Therapy Catapult is managing the conduct of a phase I/II clinical trial to test primarily the acute safety and tolerability, and longer term efficacy, of a cell therapy product in patients with Acute Respiratory Distress Syndrome. Pharmacovigilance/Safety Management services are required to cover standard clinical trial tasks including: SAE handling/reporting; production of safety management plan, narratives, safety alert letters; single case reporting, periodic/annual reporting, DSMB reporting and conducting safety reviews). A DSMB will convene on approximately 4 occasions t…