Electronic Trial Master File (inc. Electronic Archiving)

Amounts and figures

Description

The Southampton Clinical Trials Unit (SCTU) requires an electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) and eArchiving solution that meets regulatory requirements (including Eudralex Vol4 annex 11 for computerised systems). These solutions should follow the ALCOA+ principles (Attributable, legible, contemporaneously recorded, original or a true copy, accurate, complete, consistent, enduring, and available). Documents should be able to be approved with fully regulatory compliant e-signatures. The University requires data to be retrievable, along with all metadata, for up to 30 years. The SCTU expects 4-6 new trials a year, and 25 trials recruiting at any one time.

Awards

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Frequently asked questions

What is the deadline to bid for this tender?

The submission deadline is 28 June 2024, 12:00. Check the official source, as dates can be modified.

What is the estimated value of this tender?

The estimated value published by the buyer is £135,000.

Who is the buyer of this tender?

The contracting authority is UNIVERSITY OF SOUTHAMPTON (United Kingdom).

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