Quality Management System for Clinical Trials Unit

{
    "tag": [
        "compiled"
    ],
    "id": "ocds-h6vhtk-059ef6-2026-01-14T13:30:28Z",
    "date": "2026-01-14T13:30:28Z",
    "ocid": "ocds-h6vhtk-059ef6",
    "initiationType": "tender",
    "parties": [
        {
            "id": "GB-PPON-PZYG-2396-XCRZ",
            "name": "University of Exeter",
            "identifier": {
                "scheme": "GB-PPON",
                "id": "PZYG-2396-XCRZ"
            },
            "address": {
                "streetAddress": "Northcote House",
                "locality": "Exeter",
                "postalCode": "EX4 4QJ",
                "country": "GB",
                "countryName": "United Kingdom",
                "region": "UKK43"
            },
            "contactPoint": {
                "name": "Melanie Cox",
                "email": "m.cox@exeter.ac.uk",
                "telephone": "+44 139723757"
            },
            "roles": [
                "buyer"
            ],
            "details": {
                "url": "https://www.exeter.ac.uk",
                "classifications": [
                    {
                        "id": "publicAuthoritySubCentralGovernment",
                        "scheme": "UK_CA_TYPE",
                        "description": "Public authority - sub-central government"
                    }
                ]
            }
        }
    ],
    "buyer": {
        "id": "GB-PPON-PZYG-2396-XCRZ",
        "name": "University of Exeter"
    },
    "planning": {
        "milestones": [
            {
                "id": "engagement",
                "type": "engagement",
                "description": "https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=98305&B=",
                "dueDate": "2025-10-03T23:59:59Z",
                "status": "scheduled"
            }
        ],
        "documents": [
            {
                "id": "058467-2025",
                "documentType": "marketEngagementNotice",
                "noticeType": "UK2",
                "description": "Preliminary market engagement notice on Find a Tender",
                "url": "https://www.find-tender.service.gov.uk/Notice/058467-2025",
                "datePublished": "2025-09-22T12:30:40+01:00",
                "format": "text/html"
            }
        ]
    },
    "tender": {
        "id": "UOE/2025/073/MC",
        "legalBasis": {
            "id": "2023/54",
            "scheme": "UKPGA",
            "uri": "https://www.legislation.gov.uk/ukpga/2023/54/contents"
        },
        "title": "Quality Management System for Clinical Trials Unit",
        "description": "The University of Exeter Clinical Trials Unit (ExeCTU) is undertaking this procurement process to select an Electronic Quality Management System (eQMS) for use over the coming years. Whilst ExeCTU have an incumbent system they are keen to engage the market and understand whether alternative solutions add further value in respect to operational needs. Such that the selected solution as an outcome of this procurement process will align with the sector's best practice and strengthen their compliance profile to potential collaborators, which is absolute must in this sector. The sought-after solution must comply with clinical trials regulation and Good Clinical Practice, and meet expectations of regulatory inspectors. In particular, it should provide robust functionality for managing the CTU's Standard Operating Procedures and other controlled documentation. The eQMS software is utilized by up to 50 core users and with up to 3 users with full system admin rights to make amendments to the system set up. Suppliers should also be able to provide implementation support, ongoing training, and continuing system support.",
        "items": [
            {
                "id": "LOT-0000",
                "additionalClassifications": [
                    {
                        "scheme": "CPV",
                        "id": "48170000",
                        "description": "Compliance software package"
                    },
                    {
                        "scheme": "CPV",
                        "id": "48000000",
                        "description": "Software package and information systems"
                    },
                    {
                        "scheme": "CPV",
                        "id": "48100000",
                        "description": "Industry specific software package"
                    },
                    {
                        "scheme": "CPV",
                        "id": "48180000",
                        "description": "Medical software package"
                    },
                    {
                        "scheme": "CPV",
                        "id": "48610000",
                        "description": "Database systems"
                    },
                    {
                        "scheme": "CPV",
                        "id": "48611000",
                        "description": "Database software package"
                    },
                    {
                        "scheme": "CPV",
                        "id": "48612000",
                        "description": "Database-management system"
                    },
                    {
                        "scheme": "CPV",
                        "id": "48613000",
                        "description": "Electronic data management (EDM)"
                    },
                    {
                        "scheme": "CPV",
                        "id": "48614000",
                        "description": "Data-acquisition system"
                    },
                    {
                        "scheme": "CPV",
                        "id": "72000000",
                        "description": "IT services: consulting, software development, Internet and support"
                    }
                ],
                "deliveryAddresses": [
                    {
                        "region": "UKK",
                        "country": "GB",
                        "countryName": "United Kingdom"
                    },
                    {
                        "region": "UKK",
                        "country": "GB",
                        "countryName": "United Kingdom"
                    }
                ],
                "relatedLot": "LOT-0000"
            }
        ],
        "value": {
            "amountGross": 120000,
            "amount": 100000,
            "currency": "GBP"
        },
        "mainProcurementCategory": "services",
        "additionalProcurementCategories": [
            "goods"
        ],
        "aboveThreshold": false,
        "lots": [
            {
                "id": "LOT-0000",
                "suitability": {
                    "sme": true,
                    "vcse": true
                },
                "contractPeriod": {
                    "startDate": "2026-03-23T00:00:00Z",
                    "endDate": "2029-03-22T23:59:59Z",
                    "maxExtentDate": "2031-03-22T23:59:59Z"
                },
                "hasRenewal": true,
                "status": "active",
                "value": {
                    "amountGross": 120000,
                    "amount": 100000,
                    "currency": "GBP"
                },
                "selectionCriteria": {
                    "criteria": [
                        {
                            "description": "Procurement Specific Questionnaire within Invitation To Tender document accessible via the University's eTendering Portal; https://uk.eu-supply.com/login.asp?B=EXETER"
                        }
                    ]
                },
                "renewal": {
                    "description": "Two optional extension periods of 12 months each."
                },
                "awardCriteria": {
                    "description": "Most Advantageous Tender evaluation methodology comprising; 60% Technical 30% Commercial 10% Services"
                }
            }
        ],
        "communication": {
            "futureNoticeDate": "2025-12-01T23:59:59Z"
        },
        "status": "active",
        "procurementMethod": "open",
        "procurementMethodDetails": "Below threshold - open competition",
        "submissionMethodDetails": "https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=101704&TID100106938&B=",
        "submissionTerms": {
            "electronicSubmissionPolicy": "allowed"
        },
        "tenderPeriod": {
            "endDate": "2026-01-28T17:00:00+00:00"
        },
        "enquiryPeriod": {
            "endDate": "2026-01-23T17:00:00+00:00"
        },
        "documents": [
            {
                "id": "003102-2026",
                "documentType": "tenderNotice",
                "noticeType": "UK4",
                "description": "Tender notice on Find a Tender",
                "url": "https://www.find-tender.service.gov.uk/Notice/003102-2026",
                "datePublished": "2026-01-14T13:30:28Z",
                "format": "text/html"
            }
        ]
    },
    "language": "en"
}