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Awarded

Electronic Trial Master File (inc. Electronic Archiving)

Published

Supplier(s)

Cognidox Limited

Value

135,000 GBP

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.

Timeline

Publish date

4 days ago

Award date

4 days ago

Buyer information

University of Southampton

Contact:
Natasha Rook
Email:
procurement@soton.ac.uk

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Notice topics

Casemix systemClinical information systemMedical information systemsNursing information systemPatient-administration systemTheatre management system

Related topics

Casemix systemClinical information systemTheatre management systemPatient-administration systemNursing information systemMedical information systems

Source

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