--- title: "(NU/1782) Supply and Installation of a Clinical Data Management System and a Randomisation System" ocid: "ocds-h6vhtk-0367f4" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-0367f4" markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-0367f4.md" json_url: "https://d3tenders.com/contract/ocds-h6vhtk-0367f4.json" source: "Find A Tender Service" current_stage: "Award" buyer: "NEWCASTLE UNIVERSITY" published: "2023-09-07" --- # (NU/1782) Supply and Installation of a Clinical Data Management System and a Randomisation System Buyer: NEWCASTLE UNIVERSITY Current stage: Award OCID: ocds-h6vhtk-0367f4 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-h6vhtk-0367f4) [Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-0367f4.json) ## Summary Newcastle University has completed an award process for the "Supply and Installation of a Clinical Data Management System and a Randomisation System" tender. The procurement involved goods under the main procurement category, specifically database software packages. The tender was published on 2023-09-07 and awarded to Assured Information Systems Ltd. The University specified a minimum 10-day standstill period for unsuccessful tenderers to seek debriefing. The address for further information is available on Newcastle University's Procurement Services website. This tender presents an opportunity for suppliers in the medical information systems industry to compete for contracts with Newcastle University. The University required established cloud-based solutions for clinical trial environments. Businesses specializing in database software packages and operating software could find this opportunity well-suited for expanding their market presence. Interested suppliers should ensure compliance with procurement regulations and consider the 10-day standstill period for feedback in case of unsuccessful bids. ## Notice 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 System 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 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. ## Key Details | Field | Value | | --- | --- | | Publication source | Find A Tender Service | | Latest notice | https://www.find-tender.service.gov.uk/Notice/026480-2023 | | 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 | | All stages | Tender, Award | ## Dates | Field | Value | | --- | --- | | Publication date | 7 Sep 2023 | | Submission deadline | 17 Oct 2022 | | Future notice date | Not specified | | Award date | 15 Aug 2023 | | Contract period | Not specified | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £3,750,000 | | Lots value | £3,750,000 | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Complete | | Lots status | Active, Cancelled | | Awards status | Active | | Contracts status | Active | ## Buyer | Field | Value | | --- | --- | | Main buyer | NEWCASTLE UNIVERSITY | | Locality | NEWCASTLE | | Post town | Newcastle upon Tyne | | Postcode | NE1 7RU | | Country | England | | ITL 1 | TLC North East (England) | | ITL 2 | TLC4 Northumberland, Durham and Tyne & Wear | | ITL 3 | TLC43 Tyneside | | Local authority | Newcastle upon Tyne | | Electoral ward | Monument | | Westminster constituency | Newcastle upon Tyne Central and West | | Delivery location | TLC22 Tyneside | ## Supplier | Field | Value | | --- | --- | | Number of suppliers | 1 | | Supplier names | ASSURED INFORMATION SYSTEMS | ## CPV Codes ### Divisions - 48 - Software package and information systems ### Codes - 48600000 - Database and operating software package - 48611000 - Database software package - 48814000 - Medical information systems ## Release History - 7 Sep 2023 at 12:51 - Award - Award Notice - https://www.find-tender.service.gov.uk/Notice/026480-2023 - 13 Sep 2022 at 10:28 - Tender - Tender Notice - https://www.find-tender.service.gov.uk/Notice/025618-2022 ## Notice URLs - https://procontract.due-north.com/ - https://www.ncl.ac.uk ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-0367f4. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-0367f4.json.