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CTU Electronic Data Capture

Anglia Ruskin University Published 22 Mar 2021 Contracts Finder

key details

Value£27,378
Statuscomplete
Category (CPV) 48613000
Deadline21 Jan 2021
Contract start28 Feb 2021
Contract end27 Feb 2022
Proceduredirect
SME suitableYes
OCIDocds-b5fd17-98e5663a-abd3-44b6-8274-cd62f0422bca

Award

SupplierValueDateStatus
Elsevier B.V. £27,378 16 Feb 2021 active

description

This has been awarded.

The Clinical Trials Unit (CTU) needs an electronic data capture (EDC) system for its research projects. The features of this system need to have a data entry module, study design module, data management (query resolution) aspect, management of system and users, reportable, and fully auditable.

This system needs to be compliant with ICH GCP, EU Clinical Trial Directive and MHRA regulations to demonstrate that they conform with internationally recognised ethical and scientific quality requirements for the design, conduct, recording and reporting of clinical trials.

FDA 21 CFR Part 11 compliance is also recommended to meet US standards.

notice history

1 notice published against this procurement.

PublishedTypeRegimeNotice
22 Mar 2021 Award (award) · 6bbd9cee-2e63-47c0-aff7-28884ba96168-422114

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