What the buyer wrote
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 perform…
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Awarded to
Details
- What the buyer calls it
- Pharmacovigilance Management Services
- How they are buying
- The buyer did not say
- Suitable for small firms
- The buyer says yes. What that is worth
- Work starts
- 26 Jul 2015
- Work ends
- 31 Mar 2018
Who the buyer named
The buyer published a contact address on this notice.