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ocds-b5fd17-14a9ed11-4de3-4d18-a4cf-83fed29bb044Published facts
c2a3a395-5e64-44bb-9858-49b1acb5cb0f-832522The 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.
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018e45ed-5dca-4435-aaee-b74b65e444f0-754645Award notice observed
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c2a3a395-5e64-44bb-9858-49b1acb5cb0f-832522Awards and suppliers
Buyer: UNIVERSITY OF SOUTHAMPTONSupplier: Cognidox Limited
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