Notice Information
Notice Title
(NU/1782) Supply and Installation of a Clinical Data Management System and a Randomisation System
Notice Description
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. Note no award was made for Lot 2.
Lot Information
Clinical Data Mangeement System
The scope is for the supply, implementation and support for a Clinical Data Management 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.
Renewal: 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.
Lot 2 Randomisation SystemNewcastle 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 PS30m, 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.
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.
Renewal: 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.
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-h6vhtk-0367f4
- Publication Source
- Find A Tender Service
- Latest Notice
- https://www.find-tender.service.gov.uk/Notice/026480-2023
- Current Stage
- Award
- All Stages
- Tender, Award
Procurement Classification
- Notice Type
- Tender Notice
- Procurement Type
- Standard
- Procurement Category
- Goods
- Procurement Method
- Open
- Procurement Method Details
- Open procedure
- Tender Suitability
- Not specified
- Awardee Scale
- SME
Common Procurement Vocabulary (CPV)
- CPV Divisions
-
- CPV Codes
48600000 - Database and operating software package
48611000 - Database software package
48814000 - Medical information systems
Notice Value(s)
- Tender Value
- £3,750,000 £1M-£10M
- Lots Value
- £3,750,000 £1M-£10M
- Awards Value
- Not specified
- Contracts Value
- Not specified
Notice Dates
- Publication Date
- 7 Sep 20232 years ago
- Submission Deadline
- 17 Oct 2022Expired
- Future Notice Date
- Not specified
- Award Date
- 16 Aug 20233 years ago
- Contract Period
- Not specified - Not specified
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Active, Cancelled
- Awards Status
- Active
- Contracts Status
- Active
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- Newcastle University
- Contact Name
- Available with D3 Tenders Premium →
- Contact Email
- Available with D3 Tenders Premium →
- Contact Phone
- Available with D3 Tenders Premium →
Buyer Location
- Locality
- NEWCASTLE
- Postcode
- NE1 7RU
- Postcode Area
- Newcastle upon Tyne
- Country
- England
-
- Major Region (ITL 1)
- TLC North East (England)
- Basic Region (ITL 2)
- TLC4 Northumberland, Durham and Tyne & Wear
- Small Region (ITL 3)
- TLC43 Tyneside
- Delivery Location
- TLC22 Tyneside
-
- Local Authority
- Newcastle upon Tyne
- Electoral Ward
- Monument
- Westminster Constituency
- Newcastle upon Tyne Central and West
Further Information
Open Contracting Data Standard (OCDS)
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.