Source: https://tendernation.io/opportunities/01a13cfd-681c-72f0-8041-655111b1addf/electronic-trial-master-file-inc-electronic-archiving awarded GB open procedure Suitable for SMEs # Electronic Trial Master File (inc. Electronic Archiving) [University of Southampton](https://tendernation.io/buyers/university-of-southampton) Estimated value £90,000 to £135,000 Published 28 May 2024 Deadline Closed 28 Jun 2024 ## Who can bid - Buyer says suitable for SMEs The buyer ticked “suitable for SMEs” on the notice. Anyone can still bid. - Buyer says suitable for VCSEs The buyer ticked “suitable for voluntary, community and social enterprises” on the notice. - 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 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. ## CPV classification Medical information systems Source Contracts Finder (UK) [View official notice](https://www.contractsfinder.service.gov.uk/notice/14a9ed11-4de3-4d18-a4cf-83fed29bb044) 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. [Track tenders free](https://tendernation.io/register) [Buyer profile University of Southampton: past awards and live tenders](https://tendernation.io/buyers/university-of-southampton) [Sector More Software packages & information systems tenders](https://tendernation.io/sectors/software-information-systems) ## More tenders like this [Preliminary Market Engagement - Corporate Enterprise Resource Planning (ERP) · North East Lincolnshire Borough Council · 21 days left · 9 Nov 2026](https://tendernation.io/opportunities/01a15410-bf5e-72d1-8225-fbabeaba595f/preliminary-market-engagement-corporate-enterprise-resource-planning-erp) [Servers – Dostawa serwerów do klastra wirtualizacyjnego · Politechnika Rzeszowska · 2 days left · 21 Oct 2026](https://tendernation.io/opportunities/01a15183-2e23-7066-ba48-4fc2a9243b50/poland-servers-dostawa-serwerow-do-klastra-wirtualizacyjnego) [License management software package – Dostawa licencji bezpieczeństwa do Systemu DNS · Poczta Polska S.A. · 15 days left · 3 Nov 2026](https://tendernation.io/opportunities/01a15183-20fa-7396-87e7-40ce84cb0f4d/poland-license-management-software-package-dostawa-licencji-bezpieczenstwa-d) [Security software package – Pořízení a implementace integrovaného řešení EDR/XDR a SIEM · Fakultní nemocnice Plzeň · 30 days left · 18 Nov 2026](https://tendernation.io/opportunities/01a15183-1e5d-73ea-989e-b9c221c4c490/czechia-security-software-package-porizeni-a-implementace-integrovaneho-rese) [Computer servers – „Dostawa serwerów komputerowych wraz z dedykowanymi kartami graficznymi dla Copernicus PL Sp. z o.o.” · Copernicus Podmiot Leczniczy Spółka Z Ograniczoną Odpowiedzialnością · 3 days left · 22 Oct 2026](https://tendernation.io/opportunities/01a15183-08e5-7339-9a05-be1adf5996b5/poland-computer-servers-dostawa-serwerow-komputerowych-wraz-z-dedykowanymi) [Software package and information systems – Datenerfassungssystem · Dataport AöR · 15 days left · 3 Nov 2026](https://tendernation.io/opportunities/01a15183-43c5-7007-89f5-0ea2d1525f27/germany-software-package-and-information-systems-datenerfassungssystem)