Pharmacovigilance Management Services
Cell Therapy Catapult Limited · United Kingdom
Key facts
- Contract value
- £47,000
- Awarded
- 03 Aug 2015
- Contract starts
- 15 Aug 2015
- Contract ends
- 31 Mar 2018
- Procedure
- Other -
- Buyer type
- Local government
Awarded to
| Supplier | Value |
|---|---|
| Diamond PV | £47,000 |
Description
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 [email protected] 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 [email protected]. The closing date for tender clarifications is 13.00 on 19th June 2015.
Categories (CPV)
- 73000000 Research and development services and related consultancy services
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