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
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://health-family.force.com/s/Welcome
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://health-family.force.com/s/Welcome
Tenders or requests to participate must be submitted to 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
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Digital Site File Application
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 Clinical Research Directorate of the Newcastle upon Tyne NHS Foundation Trust currently maintains a large number 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 Directorate wishes to implement a fully electronic site file for each study that will vastly reduce the use of paper documents, reduce the amount of staff time spent on printing and filing and eliminate the requirement to use an off-site storage facility to archive the documents of studies that have closed.
The system must have the facility to:
a. Store and version-control documents
b. Allow electronic signature of documents
c. Be accessed and viewed remotely by non-trust employees with appropriate access controls
d. Be aligned with Good Clinical Practice (GCP) expectations around controls, security, training and validation (Section 10.5.3 in the Grey Guide)
e. Comply with Medicines & Healthcare products Regulatory Agency (MRHA) regulatory requirements
f. Create an audit trail for all activities in the system.
g. Create a comprehensive folder structure with sub-folders to facilitate storage and easy retrieval of documents
h. Be configurable to organisational requirements
j. Have search functionality for the location of documents with multiple options including pdf
j. Exchange regulatory and source documentation with Sponsor/CTU
k. Manage study timelines via alerts e.g. submission of annual reports
l. Manage “live documents” e.g. amendment logs, delegation logs, AE/SAE logs
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKC22 - Tyneside
Main site or place of performance
NE3 3HD
two.2.4) Description of the procurement
To procure a Digital Site File
two.2.5) Award criteria
Quality criterion - Name: Social Value / Weighting: 10
Quality criterion - Name: Specification / Weighting: 70
Cost criterion - Name: Commercial / Weighting: 20
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
60
This contract is subject to renewal
No
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: No
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
10 November 2023
Local time
5:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.6) Minimum time frame during which the tenderer must maintain the tender
Tender must be valid until: 28 February 2024
four.2.7) Conditions for opening of tenders
Date
9 October 2023
Local time
2:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: Yes
Estimated timing for further notices to be published: January 2028
six.4) Procedures for review
six.4.1) Review body
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Regent Point
NEWCASTLE UPON TYNE
NE7 7DN
Country
United Kingdom