United Kingdom-Newcastle: (NU/1782) Supply and Installation of a Clinical Data Management System and a Randomisation System

Type of document: Contract Notice
Country: United Kingdom
Publication Ref: (2022/S 000-025618/EN)
Nature of contract: Supply contract
Procedure: Open procedure
Type of bid required: Global bid

Contract notice
Supplies

Section I: Contracting authority
I.1) Name and addresses
Official name: Newcastle University
Postal address: Newcastle University, Procurement Services, Kingsgate
Town: Newcastle
Postal code: NE1 7RU
Country: United Kingdom
Contact Person: Dr Emma Barksby
Telephone: +44 1912086298
Email: emma.barksby@ncl.ac.uk
Internet address(es):
Main address:
Address of the buyer profile:

I.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge,at:
Additional information can be obtained from:
the above mentioned address
Tenders or requests to participate must be submitted:
electronically via:
I.4) Type of the contracting authority
Body governed by public law
I.5) Main activity
Education

Section II: Object
II.1) Scope of the procurement
II.1.1) Title: (NU/1782) Supply and Installation of a Clinical Data Management System and a Randomisation System

Reference number: DN629737
II.1.2) Main CPV code: 48810000
II.1.3) Type of contract: Supplies
II.1.4) Short Description: Newcastle Clinical Trials Unit (NCTU) is a UKCRC Registered CTU that works in collaboration with investigators to design and deliver clinical trials and studies answering important clinical questions, whose findings bring substantial impact to patients and the NHS; it has a portfolio across many clinical disciplines and from different funders (public, commercial, and charitable). There are currently over 40 active interventional trials with a total funding value is excess of £30m, these include international trials and a growing portfolio of trials with adaptive designs. Most of the portfolio are regulated by the Medicines for Healthcare Products Regulatory Agency (MHRA).
NCTU works in a demanding and constantly evolving ethical, legal, regulatory and scientific landscape, across multiple countries. We seek opportunities for faster, more efficient, cost effective, and better research. NCTU requires systems that ensures robust trial design are conducted in line with MHRA and other legislated regulatory requirements that stand up to international scrutiny. The systems(s) must be suitable for use in academic trials units and ensure they operate in a way which is complaint with applicable legislation. The systems should combine excellent functionality with customisability that will also require the set-up time of trials to be minimised without impacting on staff time needed to develop, test, and deploy trials and studies within the system. Staff move between locations to work, including from NHS Trusts and from home, and thus secure access from any location is needed to both build and manage the systems.
The scope is for the supply, implementation and support for a Clinical Data Management System and Randomisation System to be used by all members of the NCTU, and by trial teams across multiple clinical sites, nationally and globally. The requirements are for established cloud-based, off the shelf solutions which are in use within clinical trial environments. The systems must be accessed via a web-based interface. The systems must have different user profiles to support the setting up, management and data removal for statistical analysis.
This tender process is divided two lots. Suppliers may submit a bid for one of the lots or both lots. Each Lot will be assessed separately. Lot 1 – Clinical Data Management System and Lot 2 – Randomisation System.
II.1.5) Estimated total value:
Value excluding VAT: 3750000 Currency: GBPII.1.6) Information about lots:
The contract is divided into lots: Yes
Tenders may be submitted for all lots
II.2) Description
II.2.1) Title: Lot 1 Clinical Data Management System

Lot No:1
II.2.2) Additional CPV code(s)
48600000

II.2.3) Place of performance
Nuts code:
II.2.4) Description of the procurement:
Newcastle Clinical Trials Unit (NCTU) is a UKCRC Registered CTU that works in collaboration with investigators to design and deliver clinical trials and studies answering important clinical questions, whose findings bring substantial impact to patients and the NHS; it has a portfolio across many clinical disciplines and from different funders (public, commercial, and charitable). There are currently over 40 active interventional trials with a total funding value is excess of £30m, these include international trials and a growing portfolio of trials with adaptive designs. Most of the portfolio are regulated by the Medicines for Healthcare Products Regulatory Agency (MHRA).
NCTU works in a demanding and constantly evolving ethical, legal, regulatory and scientific landscape, across multiple countries. We seek opportunities for faster, more efficient, cost effective, and better research. NCTU requires systems that ensures robust trial design are conducted in line with MHRA and other legislated regulatory requirements that stand up to international scrutiny. The systems(s) must be suitable for use in academic trials units and ensure they operate in a way which is complaint with applicable legislation. The systems should combine excellent functionality with customisability that will also require the set-up time of trials to be minimised without impacting on staff time needed to develop, test, and deploy trials and studies within the system. Staff move between locations to work, including from NHS Trusts and from home, and thus secure access from any location is needed to both build and manage the systems.
The scope is for the supply, implementation and support for a Clinical Data Management System and Randomisation System to be used by all members of the NCTU, and by trial teams across multiple clinical sites, nationally and globally. The requirements are for established cloud-based, off the shelf solutions which are in use within clinical trial environments. The systems must be accessed via a web-based interface. The systems must have different user profiles to support the setting up, management and data removal for statistical analysis.
This tender process is divided two lots. Suppliers may submit a bid for one of the lots or both lots. Each Lot will be assessed separately. Lot 1 – Clinical Data Management System and Lot 2 – Randomisation System.
II.2.5) Award criteria

II.2.6) Estimated value:
Value excluding VAT: 2000000 Currency: GBP
II.2.7) Duration of the contract,framework agreement or dynamic purchasing system
Duration in months: 60
This contract is subject to renewalyes Description of renewals:The initial contract term shall be for 5 years from the go-live date with an option to extend the contract for an additional 5 years, or for periods of 2 years thereafter. The total number of years for live running before a full re-tender exercise is undertaken shall not exceed 15 years. The justification for the length of contract is length of time for the clinical trials and the difficulty of extracting the data from live trials.

II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted: no
II.2.11) Information about options
Options: no
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:no
II.2.1) Title: Lot 2 Randomisation System

Lot No:2
II.2.2) Additional CPV code(s)
48600000

II.2.3) Place of performance
Nuts code:
II.2.4) Description of the procurement:
Newcastle Clinical Trials Unit (NCTU) is a UKCRC Registered CTU that works in collaboration with investigators to design and deliver clinical trials and studies answering important clinical questions, whose findings bring substantial impact to patients and the NHS; it has a portfolio across many clinical disciplines and from different funders (public, commercial, and charitable). There are currently over 40 active interventional trials with a total funding value is excess of £30m, these include international trials and a growing portfolio of trials with adaptive designs. Most of the portfolio are regulated by the Medicines for Healthcare Products Regulatory Agency (MHRA).
NCTU works in a demanding and constantly evolving ethical, legal, regulatory and scientific landscape, across multiple countries. We seek opportunities for faster, more efficient, cost effective, and better research. NCTU requires systems that ensures robust trial design are conducted in line with MHRA and other legislated regulatory requirements that stand up to international scrutiny. The systems(s) must be suitable for use in academic trials units and ensure they operate in a way which is complaint with applicable legislation. The systems should combine excellent functionality with customisability that will also require the set-up time of trials to be minimised without impacting on staff time needed to develop, test, and deploy trials and studies within the system. Staff move between locations to work, including from NHS Trusts and from home, and thus secure access from any location is needed to both build and manage the systems.
The scope is for the supply, implementation and support for a Clinical Data Management System and Randomisation System to be used by all members of the NCTU, and by trial teams across multiple clinical sites, nationally and globally. The requirements are for established cloud-based, off the shelf solutions which are in use within clinical trial environments. The systems must be accessed via a web-based interface. The systems must have different user profiles to support the setting up, management and data removal for statistical analysis.
This tender process is divided two lots. Suppliers may submit a bid for one of the lots or both lots. Each Lot will be assessed separately. Lot 1 – Clinical Data Management System and Lot 2 – Randomisation System.
II.2.5) Award criteria

II.2.6) Estimated value:
Value excluding VAT: 1750000 Currency: GBP
II.2.7) Duration of the contract,framework agreement or dynamic purchasing system
Duration in months: 60
This contract is subject to renewalyes Description of renewals:The initial contract term shall be for 5 years from the go-live date with an option to extend the contract for an additional 5 years, or for periods of 2 years thereafter. The total number of years for live running before a full re-tender exercise is undertaken shall not exceed 15 years. The justification for the length of contract is length of time for the clinical trials and the difficulty of extracting the data from live trials.

II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted: no
II.2.11) Information about options
Options yes
Description of options: The initial contract term shall be for 5 years from the go-live date with an option to extend the contract for an additional 5 years, or for periods of 2 years thereafter. The total number of years for live running before a full re-tender exercise is undertaken shall not exceed 15 years. The justification for the length of contract is length of time for the clinical trials and the difficulty of extracting the data from live trials.

II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:no
Section IV: Procedure
IV.1) Description
IV.1.1) Type of procedure:
Open procedureIV.1.8) Information about the Government Procurement Agreement(GPA)
The procurement is covered by the Government Procurement Agreement: yes
IV.2) Administrative information
IV.2.2) Time limit for receipt of tenders or requests to participate
Date: 2022-10-17 Local time: 12:00
IV.2.4) Languages in which tenders or requests to participate may be submitted:EN
IV.2.6) Minimum time frame during which the tender must maintain the tender
Duration in months:3(from the date stated for receipt of tender)
IV.2.7) Conditions for opening tenders
Date: 2022-10-17 Local time: 14:00

Section VI: Complementary information
VI.1) Information about recurrence:
This is a recurrent procurement: no
VI.2) Information about electronic workflows
VI.4) Procedures for review
VI.4.1) Review body
Official name: Newcastle University
Town: Newcastle upon Tyne
Country: United Kingdom
Internet address:

VI.4.3) Review procedure
Precise information on deadline(s) for review procedures:
Newcastle University will incorporate a minimum 10 calendar day standstill period at the point information on the award of the contract is communicated to tenderers. This period allows unsuccessful tenderers to seek further debriefing before the contract is entered into. Applicants have 2 working days from notification of the award decision to request additional debriefing and 4 / 4 that information has to be provided a minimum of 3 working days before expiry of the standstill period. Such additional information should be requested from the address referred to in part 1.1 above. If an appeal regarding the award of a contract has not been successfully resolved, the Public Contracts Regulations 2015 provide for aggrieved parties who have been harmed or are at risk of harm by a breach of the rules to take action in the High Court (England, Wales and Northern Ireland). Any such action must be brought promptly. Where a contract has not been entered into the Court may order the setting aside of the award decision or order the authority to amend any document and may award damages. If the contract has been entered into the Court may only award damages

VI.5) Date of dispatch of this notice:2022-09-13