Section one: Contracting authority
one.1) Name and addresses
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital, Freeman Road, High Heaton
Newcastle-upon-Tyne
NE7 7DN
Contact
Ewan Bond
Telephone
+44 1912138916
Country
United Kingdom
Region code
UKC22 - Tyneside
Internet address(es)
Main address
https://www.newcastle-hospitals.nhs.uk
Buyer's address
https://www.newcastle-hospitals.nhs.uk
one.3) Communication
Additional information can be obtained from the above-mentioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
https://health-family.force.com/s/Welcome
one.4) Type of the contracting authority
Ministry or any other national or federal authority
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Electronic Investigator Site File system (eISF) - Medical Research
two.1.2) Main CPV code
- 48000000 - Software package and information systems
two.1.3) Type of contract
Supplies
two.1.4) Short description
The requirement is to provide an electronic Investigator Site File system (eISF) for the digitisation, administration, storage, management and approval of research documentation. The solution will require access for around 600-1000 end users, this isn't expected to be concurrent.
two.1.5) Estimated total value
Value excluding VAT: £100,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKC2 - Northumberland and Tyne and Wear
two.2.4) Description of the procurement
To procure a digital site file for medical research carried out at a UK Hospital for the digitisation, administration, storage, management and approval of research documentation.
two.3) Estimated date of publication of contract notice
5 June 2023
Section four. Procedure
four.1) Description
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: No
Section six. Complementary information
six.3) Additional information
To procure a digital site file for medical research carried out at a UK Hospital for the digitisation, administration, storage, management, and approval of research documentation.
Additional information
The Hospital maintains vast numbers of paper site files relating to study governance. Each site file contains documents such as study protocols, ethics regulatory approvals, delegation logs, training logs, consent forms and email correspondence. Each study will have between three and ten large lever arch site files and there are currently 1,400 studies in progress. Many of the above documents are dynamic and version-controlled and paper copies of all changes must be retained for audit purposes. After study closure the files are sent to an off-site storage facility for periods ranging from five to 25 years depending on the nature of the study.
The Hospital wishes to implement a fully electronic site file for each study that eliminates the use of paper documents, reduces the amount of staff time spent on printing and saves the cost of using an off-site storage facility to archive the documents of studies that have closed. The system must be an off the shelf software package provided as a cloud-based service that is already in use in a research environment and comply with FDA Part 11 requirements for electronic signatures. All data must be held in either the UK or the European Economic Area.
Requirements from Supplier
Confirm with the authority of their interest in the contract by the 14th of July 2023.
It is envisaged that a restricted tender process will be undertaken. This likely to take place during the months of August through to October.
Suppliers will be requested to respond to a specification as part of the tendering process.