EC0810 Clinical trial formulation, Anne Rowling Clinic

{
    "tag": [
        "compiled"
    ],
    "id": "ocds-r6ebe6-0000548039-2018-06-29T00:00:00Z",
    "date": "2018-06-29T00:00:00Z",
    "ocid": "ocds-r6ebe6-0000548039",
    "initiationType": "tender",
    "parties": [
        {
            "id": "org-57",
            "name": "University Of Edinburgh",
            "identifier": {
                "legalName": "University Of Edinburgh"
            },
            "address": {
                "streetAddress": "Charles Stewart House, 9-16 Chambers Street",
                "locality": "Edinburgh",
                "region": "UKM75",
                "postalCode": "EH1 1HT"
            },
            "contactPoint": {
                "email": "mmuir33@ed.ac.uk",
                "telephone": "+44 1316509131",
                "url": "https://www.publictendersscotland.publiccontractsscotland.gov.uk/web/login.html"
            },
            "roles": [
                "buyer",
                "centralPurchasingBody",
                "reviewBody"
            ],
            "details": {
                "classifications": [
                    {
                        "id": "Body governed by public law",
                        "scheme": "TED_CA_TYPE"
                    },
                    {
                        "id": "09",
                        "description": "Education",
                        "scheme": "COFOG"
                    }
                ],
                "url": "http://www.ed.ac.uk/schools-departments/procurement/supplying"
            }
        }
    ],
    "buyer": {
        "name": "University Of Edinburgh",
        "id": "org-57"
    },
    "tender": {
        "id": "EC0810",
        "title": "EC0810 Clinical trial formulation, Anne Rowling Clinic",
        "description": "Clinical Investigational Medical Produce (IMP) trial-Manufacture, labelling, storage and distribution of the IMP and placebo as required.",
        "status": "active",
        "items": [
            {
                "id": "1",
                "additionalClassifications": [
                    {
                        "id": "33698000",
                        "scheme": "CPV"
                    }
                ],
                "deliveryAddresses": [
                    {
                        "region": "UKM75"
                    }
                ],
                "relatedLot": "1"
            }
        ],
        "value": {
            "amount": 450000,
            "currency": "GBP"
        },
        "procurementMethod": "open",
        "procurementMethodDetails": "Open procedure",
        "mainProcurementCategory": "goods",
        "submissionMethod": [
            "written"
        ],
        "tenderPeriod": {
            "endDate": "2018-08-13T12:00:00Z"
        },
        "awardPeriod": {
            "startDate": "2018-08-13T12:00:00Z"
        },
        "documents": [
            {
                "id": "JUL323739",
                "documentType": "contractNotice",
                "title": "EC0810 Clinical trial formulation, Anne Rowling Clinic",
                "description": "Clinical Investigational Medical Produce (IMP) trial-Manufacture, labelling, storage and distribution of the IMP and placebo as required.",
                "url": "https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=JUL323739",
                "format": "text/html"
            },
            {
                "id": "JUL323739-1",
                "title": "Confidentiality Agreement must be completed and returned before the ITT and Schedules are issued.",
                "url": "https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=JUL323739&idx=1",
                "datePublished": "2018-07-03T15:42:29Z",
                "dateModified": "2018-07-03T15:42:29Z",
                "format": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
            },
            {
                "id": "JUL323739-2",
                "title": "Schedules to the Invitation to Tender - Schedule 8: Supply Chain Code of Conduct",
                "url": "https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=JUL323739&idx=2",
                "datePublished": "2018-07-03T16:13:09Z",
                "dateModified": "2018-07-03T16:13:09Z",
                "format": "application/pdf"
            },
            {
                "id": "JUL323739-3",
                "title": "ESPD for completion and upload / return with your tender response.",
                "url": "https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=JUL323739&idx=3",
                "datePublished": "2018-07-03T16:20:03Z",
                "dateModified": "2018-07-03T16:20:03Z",
                "format": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
            },
            {
                "id": "JUL323739-4",
                "title": "Schedule 7: Freedom of Information.",
                "url": "https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=JUL323739&idx=4",
                "datePublished": "2018-07-03T16:22:12Z",
                "dateModified": "2018-07-03T16:22:12Z",
                "format": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
            },
            {
                "id": "JUL323739-5",
                "title": "Schedules to the Invitation to Tender - Schedule 6: Form of Tender.",
                "url": "https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=JUL323739&idx=5",
                "datePublished": "2018-07-03T16:23:20Z",
                "dateModified": "2018-07-03T16:23:20Z",
                "format": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
            },
            {
                "id": "JUL323739-6",
                "title": "This must be completed for any entities the bidder intends to rely on to meet the selection criteria",
                "url": "https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=JUL323739&idx=6",
                "datePublished": "2018-07-03T16:39:18Z",
                "dateModified": "2018-07-03T16:39:18Z",
                "format": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
            },
            {
                "id": "JUL323739-7",
                "title": "Bidders must be able to answer 'Yes' to each question in order to progress to evaluation.",
                "url": "https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=JUL323739&idx=7",
                "datePublished": "2018-07-03T16:41:56Z",
                "dateModified": "2018-07-03T16:41:56Z",
                "format": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
            },
            {
                "id": "JUL323739-8",
                "title": "EC0810 Drug Supply Agreement Template 28 June 2018 - Schedule 5",
                "url": "https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=JUL323739&idx=8",
                "datePublished": "2018-07-03T16:43:35Z",
                "dateModified": "2018-07-03T16:43:35Z",
                "format": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
            },
            {
                "id": "JUL323739-9",
                "title": "4C.1.2 Technical Experience - use this to answer question 4C.1.2 of your ESPD response.",
                "url": "https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=JUL323739&idx=9",
                "datePublished": "2018-07-03T16:49:00Z",
                "dateModified": "2018-07-03T16:49:00Z",
                "format": "application/msword"
            }
        ],
        "lots": [
            {
                "id": "1",
                "description": "Double blind randomised clinical IMP trial- Manufacture of liquid form of 2 active ingredients and matching placebo, provision of dossier for MHRA application and approval, labelling, storage and distribution of the IMP and placebo as required.",
                "status": "active",
                "value": {
                    "amount": 450000,
                    "currency": "GBP"
                },
                "options": {
                    "description": "Extension to project on a per patient, 6 month trial basis 1 x additional site (United Kingdom) 1 x Replacement IMP cost independent of ingredients/materials"
                },
                "hasOptions": true,
                "submissionTerms": {
                    "variantPolicy": "notAllowed"
                },
                "contractPeriod": {
                    "durationInDays": 1080
                },
                "hasRenewal": true,
                "renewal": {
                    "description": "Up to 12 month extension is available."
                }
            }
        ],
        "participationFees": [
            {
                "id": "1",
                "type": [
                    "document"
                ]
            }
        ],
        "bidOpening": {
            "date": "2018-08-13T12:00:00Z"
        },
        "coveredBy": [
            "GPA"
        ],
        "otherRequirements": {
            "requiresStaffNamesAndQualifications": true
        },
        "selectionCriteria": {
            "criteria": [
                {
                    "type": "suitability",
                    "description": "Professional Minimum Standards are contained in the Technical envelope of the ITT and are listed below: Bidders will be required to provide examples/information that demonstrate that they have the relevant experience to deliver the services/supplies. Bidders will be required to detail their past experience/capability in the following areas: - Warehouse technology employed; - Inventory management systems; - Warehouse locations;ar - Fleet size/capability; - Warehouse size/capability; - Standard contingency plans/policies; - Key staff experience/qualifications; - Number of pharmacies served/Fleet to pharmacy served ratio; - Supply chain/base coverage."
                },
                {
                    "type": "economic",
                    "description": "ESPD 4B.1.1 Statement Bidders will be required to have a minimum \"general\" yearly turnover of twice the contract value for the last two years preceding the date of this Contract Notice. ESPD 4B.2.1 Statement Bidders will be required to have a minimum yearly turnover of twice the contract value in the business area covered by the contract (Clinical Trials) ESPD 4B.3 Statement Where turnover information is not available for the period requested, the bidder will be required to state the date that they were set up/started trading. ESPD 4B.4 Statement Bidders will be required to state the value(s) for the following financial ratio(s): Current Ratio, defined as Current Assets divided by Current Liabilities; and Acid Test Ratio defined as (Current Assets - Stock) divided by Current Liabilities. The acceptable range for each financial ratio is: Current Ratio should be equal to or exceed 2.0. Acid Test Ratio should be equal to or exceed 1.5. ESPD 4B.5.1 and 4B.5.2 Statements It is a requirement of this contract that bidders hold, or can commit to obtain prior to the commencement of any subsequently awarded contract, the types and levels of insurance indicated below: Employer's (Compulsory) Liability Insurance = a minimum of 5,000,000 GBP Public Liability Insurance = any one incident a minimum of 2,000,000 GBP Professional Indemnity Insurance = a minimum of 1,000,000 GBP Product Liability Insurance = any one incident a minimum of 5,000,000 GBP. http://www.hse.gov.uk/pubns/hse40.pdf"
                },
                {
                    "type": "technical",
                    "description": "ESPD 4C.1.2 Statement Bidders will be required to provide 2 examples from the previous 3 years that demonstrate that they have the relevant experience to deliver the services/supplies as described in part II.2.4 of the OJEU Contract Notice. These examples must be of comparable value and complexity to the current requirement. Responses should be clearly labelled and provided in a single document attached to the response box in PCS-T. Responses should contain the following information for each example: Project Value Dates Client contact information Description of Project Client testimonials if available Note: if you are unable to provide examples please explain why. ESPD 4C.10 Statement Bidders will be required to confirm whether they intend to subcontract and, if so, for what proportion of the contract. ESPD 4C.11 Statement Bidders must confirm that they will provide samples, descriptions and/or photographs of the products to be supplied which do not require a certificate of authenticity ESPD 4C.11.1 Statement The bidder must confirm that they will provide certificates of authenticity where required. ESPD 4C.12 Statement Bidders will be required to confirm that they have the required quality control institute certificates (or from agencies of recognised competence) confirming that products meet the following technical specifications or standards: 1. Is the tenderer MHRA licenced for human medicinal products? 2. Does the tenderer have an MHRA Investigational Medicinal Products licence? 3. Does the tenderer have GCP, GMP and GDP certification? 4. Does the tenderer have a Manufacturers/Wholesale dealers license? 5. Does the tenderer have a Manufacturing and Importing Authorisation licence?",
                    "minimum": "ESPD 4D.1 Statements 4D.1 Statement 1: Quality Management The bidder must hold a UKAS (or equivalent) accredited independent third party certificate of compliance in accordance with BS EN ISO 9001 (or equivalent), 4D.1 Statement 2: Health & Safety The bidder must hold a UKAS (or equivalent), accredited independent third party certificate of compliance in accordance with BS OHSAS 18001 (or equivalent). ESPD 4D.1.1 Statements 4D.1.1 Statement 1: If the bidder does not hold a UKAS (or equivalent) accredited independent third party certificate of compliance in accordance with BS EN ISO 9001 (or equivalent), The bidder must have the following: Equivalent, documented policy and procedures regarding quality management, endorsed by the Chief Executive Officer, or equivalent. These must include the following documented items relevant to the nature and scale of the work to be carried out, which are equivalent to the standards listed above -- a policy with set responsibilities, review and improvement procedures, quality management and performance process, workforce training, skills and information process, monitoring arrangements, bidder quality management arrangements, and a process for managing complaints. 4D.1.1 Statement 2: If the bidder does not hold a UKAS (or equivalent), accredited independent third party certificate of compliance in accordance with BS OHSAS 18001 (or equivalent) or have, within the last 12 months, successfully met the assessment requirements of a construction-related scheme in registered membership of the Safety Schemes in Procurement (SSIP) forum, then the bidder must have the following: Equivalent, regularly reviewed and documented policy and procedures for Health and Safety (H&S) management, endorsed by the Chief Executive Officer, or equivalent. Note - Organisations with fewer than five employees are not required by law to have a documented policy statement. ESPD 4D.2 Statement The Bidder must hold a UKAS (or equivalent) accredited independent third party certificate of compliance with BS EN ISO 14001 (or equivalent) or a valid EMAS (or equivalent) certificate. ESPD 4D.2.1 Statement If the bidder does not hold UKAS (or equivalent) accredited independent third party certificate of compliance with BS EN ISO 14001 (or equivalent) or a valid EMAS (or equivalent) certificate, then the bidder must have the following: Equivalent, regularly reviewed documented policy and procedures regarding environmental management, authorised by the Chief Executive, or equivalent. These must include the following documented processes and arrangements relevant to the nature and scale of the work to be carried out, which are equivalent to the standards listed above - ensuring effectiveness of measures and reducing impacts, workforce training and skills, checking and reviewing, dealing with waste, and ensuring any suppliers the bidders engages apply appropriate environmental protection measures."
                }
            ]
        },
        "submissionTerms": {
            "languages": [
                "en"
            ],
            "bidValidityPeriod": {
                "durationInDays": 90
            }
        },
        "classification": {
            "id": "33698000",
            "scheme": "CPV"
        },
        "hasRecurrence": false
    },
    "language": "EN",
    "description": "1. In order to gain access to this ITT, bidders must complete a confidentiality agreement. All information supplied by The University of Edinburgh in connection with the Invitation to Tender shall be treated as confidential by bidders except that such information may be disclosed for the purpose of obtaining sureties and quotations necessary for the preparation and submission of the tender, this includes consortia members, sub-contractors and advisors. 2. Contract Modifications / Variations The nature of the work detailed in this tender, subjects it to possible changes, modifications or variations. The possible changes/modifications/variations are as follows; Dose - the millilitre (ml) dosages presented in the tender are indicative and may be subject to change. The nature of this change will be minor and the University will rely on the supplier to recommend a better solution. Duration - the tender allows for a possible extension of up to 12 months. This is to cover any delays or further patient recruitment. Stopping an IMP - the nature of this project may render an IMP unusable and as such, the University reserves the right to pull an IMP from the contract. Introducing a new IMP - the nature of this project, may require a provision to add a new drug to the trial. Quantities are likely to be similar as detailed in tender (i.e. number of patients), depending on when during the trial the new drug is introduced. Sample size - the nature of this project may require the patient sample size of increase or decrease. The University reserves the right to alter this accordingly. None of these amendments are intended to create a new contract. NOTE: To register your interest in this notice and obtain any additional information please visit the Public Contracts Scotland Web Site at https://www.publiccontractsscotland.gov.uk/Search/Search_Switch.aspx?ID=548039. (SC Ref:548039)",
    "links": [
        {
            "rel": "canonical",
            "href": "https://api.publiccontractsscotland.gov.uk/v1/Notice?id=ocds-r6ebe6-0000548039"
        }
    ],
    "noticetype": "OJEU - F2 - Contract Notice"
}