Pharmacovigilance Management Services
CELL THERAPY CATAPULT LIMITEDEstimated Value
£47,000 – £57,000
Deadline
30 June 2015
Published
27 May 2015
Type
Not specified
Overview
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.
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CELL THERAPY CATAPULT LIMITEDKey Dates
Published
27 May 2015
Submission deadline
30 June 2015
Notice type
award
Source
contracts finder
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