{ "tag": [ "compiled" ], "id": "ocds-h6vhtk-0367f4-2023-09-07T13:51:38+01:00", "date": "2023-09-07T13:51:38+01:00", "ocid": "ocds-h6vhtk-0367f4", "initiationType": "tender", "tender": { "id": "DN629737", "legalBasis": { "id": "32014L0024", "scheme": "CELEX" }, "title": "(NU/1782) Supply and Installation of a Clinical Data Management System and a Randomisation System", "status": "complete", "classification": { "scheme": "CPV", "id": "48611000", "description": "Database software package" }, "mainProcurementCategory": "goods", "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.", "value": { "amount": 3750000, "currency": "GBP" }, "lots": [ { "id": "1", "title": "Clinical Data Mangeement System", "description": "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.", "value": { "amount": 2000000, "currency": "GBP" }, "contractPeriod": { "durationInDays": 1800 }, "hasRenewal": true, "renewal": { "description": "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." }, "submissionTerms": { "variantPolicy": "notAllowed" }, "hasOptions": false, "status": "cancelled", "awardCriteria": { "criteria": [ { "name": "Technical and Functional Requirements", "type": "quality", "description": "30" }, { "name": "Non Functional Requirements", "type": "quality", "description": "10" }, { "name": "Usability", "type": "quality", "description": "20" }, { "name": "Whole Life Cost", "type": "cost", "description": "40" } ] } }, { "id": "2", "title": "Lot 2 Randomisation System", "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 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.", "value": { "amount": 1750000, "currency": "GBP" }, "contractPeriod": { "durationInDays": 1800 }, "hasRenewal": true, "renewal": { "description": "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." }, "submissionTerms": { "variantPolicy": "notAllowed" }, "hasOptions": true, "options": { "description": "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." }, "status": "active" } ], "items": [ { "id": "1", "additionalClassifications": [ { "scheme": "CPV", "id": "48814000", "description": "Medical information systems" } ], "deliveryAddresses": [ { "region": "UKC22" }, { "region": "UKC22" } ], "relatedLot": "1" }, { "id": "2", "additionalClassifications": [ { "scheme": "CPV", "id": "48600000", "description": "Database and operating software package" } ], "deliveryAddresses": [ { "region": "UKC22" } ], "relatedLot": "2" } ], "submissionMethod": [ "electronicSubmission" ], "submissionMethodDetails": "https://procontract.due-north.com/", "procurementMethod": "open", "procurementMethodDetails": "Open procedure", "coveredBy": [ "GPA" ], "tenderPeriod": { "endDate": "2022-10-17T12:00:00+01:00" }, "submissionTerms": { "languages": [ "en" ], "bidValidityPeriod": { "durationInDays": 90 } }, "awardPeriod": { "startDate": "2022-10-17T14:00:00+01:00" }, "bidOpening": { "date": "2022-10-17T14:00:00+01:00" }, "hasRecurrence": false, "reviewDetails": "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 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." }, "parties": [ { "id": "GB-FTS-168", "name": "Newcastle University", "identifier": { "legalName": "Newcastle University" }, "address": { "streetAddress": "Newcastle University, Procurement Services, Kingsgate", "locality": "Newcastle", "region": "UKC22", "postalCode": "NE1 7RU", "countryName": "United Kingdom" }, "contactPoint": { "name": "Dr Emma Barksby", "telephone": "+44 1912086298", "email": "emma.barksby@ncl.ac.uk", "url": "https://procontract.due-north.com/" }, "roles": [ "buyer" ], "details": { "url": "https://www.ncl.ac.uk", "buyerProfile": "https://www.ncl.ac.uk", "classifications": [ { "scheme": "TED_CA_TYPE", "id": "BODY_PUBLIC", "description": "Body governed by public law" }, { "scheme": "COFOG", "id": "09", "description": "Education" } ] } }, { "id": "GB-FTS-7395", "name": "Newcastle University", "identifier": { "legalName": "Newcastle University" }, "address": { "locality": "Newcastle upon Tyne", "countryName": "United Kingdom" }, "roles": [ "reviewBody" ], "details": { "url": "https://www.ncl.ac.uk" } }, { "id": "GB-FTS-92038", "name": "Assured Information Systems Ltd", "identifier": { "legalName": "Assured Information Systems Ltd" }, "address": { "streetAddress": "5 Eaton Court Road", "locality": "Colmworth Business Park", "region": "UKH12", "postalCode": "PE19 8ER", "countryName": "United Kingdom" }, "roles": [ "supplier" ], "details": { "url": "https://www.ncl.ac.uk", "scale": "sme" } } ], "buyer": { "id": "GB-FTS-168", "name": "Newcastle University" }, "language": "en", "awards": [ { "id": "026480-2023-(NU/1782)-1", "relatedLots": [ "1" ], "title": "(NU/1782) Supply and Installation of a Clinical Data Management System and a Randomisation System", "status": "active", "suppliers": [ { "id": "GB-FTS-92038", "name": "Assured Information Systems Ltd" } ] } ], "contracts": [ { "id": "026480-2023-(NU/1782)-1", "awardID": "026480-2023-(NU/1782)-1", "title": "(NU/1782) Supply and Installation of a Clinical Data Management System and a Randomisation System", "status": "active", "dateSigned": "2023-08-16T00:00:00+01:00" } ], "bids": { "statistics": [ { "id": "5", "measure": "bids", "relatedLot": "1", "value": 2 }, { "id": "6", "measure": "smeBids", "relatedLot": "1", "value": 2 }, { "id": "7", "measure": "foreignBidsFromEU", "relatedLot": "1", "value": 1 }, { "id": "8", "measure": "foreignBidsFromNonEU", "relatedLot": "1", "value": 0 }, { "id": "9", "measure": "electronicBids", "relatedLot": "1", "value": 2 }, { "id": "3", "measure": "lowestValidBidValue", "relatedLot": "1", "value": 600000, "currency": "GBP" }, { "id": "4", "measure": "highestValidBidValue", "relatedLot": "1", "value": 2000000, "currency": "GBP" }, { "id": "1", "measure": "lowestValidBidValue", "value": 600000, "currency": "GBP" }, { "id": "2", "measure": "highestValidBidValue", "value": 2000000, "currency": "GBP" } ] } }