Source: https://tendernation.io/opportunities/01a13bf9-17ea-7391-b795-a7375b89e48d/pharmacovigilance-management-services awarded GB open procedure Suitable for SMEs # Pharmacovigilance Management Services [Cell Therapy Catapult Limited](https://tendernation.io/buyers/cell-therapy-catapult-limited) Often single bidder Estimated value £47,000 to £57,000 Published 18 Nov 2016 Deadline Closed 30 Jun 2015 ## Who can bid - Buyer says suitable for SMEs The buyer ticked “suitable for SMEs” on the notice. Anyone can still bid. - Small contract value Valued under £135,018 including VAT, the lowest Procurement Act threshold for goods and services. - Open procedure Anyone can submit a full tender; there is no shortlisting stage. [More contracts for small businesses and VCSEs](https://tendernation.io/opportunities/for-small-businesses) ## About this tender 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 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 . The closing date for tender clarifications is 13.00 on 19th June 2015. ## CPV classification Research and development services and related consultancy services Source Contracts Finder (UK) [View official notice](https://www.contractsfinder.service.gov.uk/notice/6e4ccdd3-adc8-11e6-9901-0019b9f3037b) Never miss a tender like this again Get AI summaries, deadline alerts and a bid pipeline for tenders matched to your business. Free to start. 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