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 to review interim, unblinded safety data. The primary analysis for safety and efficacy will be performed once the last subject in Cohort 3 completes the Day 28 visit. This is a product that has previously been given to over 200 patients (including UK) in other disease areas.

Additional information: Bidders wishing to submit a tender are requested to complete the attached response document, including the requested attachments and return them to tenders@ct.catapult.org.uk by the closing date which is 13.00 30th June 2015

Bidders wishing to seek clarifications in relation to the tender or associated documentation may submit queries to tenders@ct.catapult.org.uk. The closing date for tender clarifications is 13.00 on 19th June 2015.