Mae'r dogfennau caffael ar gael ar gyfer mynediad uniongyrchol anghyfyngedig a llawn, yn rhad ac am ddim ar:
Mae cyfathrebu electronig yn gofyn am ddefnyddio offer a dyfeisiau nad ydynt ar gael yn gyffredinol. Mae mynediad uniongyrchol anghyfgyfyngiedig a llawn i'r offer a dyfeisiau hyn yn bosibl, yn rhad ac am ddim, yn:
II.1.1) Teitl
Lotted Term Framework for the management and manufacture of research drugs including over-labelling, storage and distribution to trial sites, and associated trial monitoring services
Cyfeirnod: UoD-LAB432-TC-2023
II.1.2) Prif god CPV
73110000
II.1.3) Y math o gontract
Gwasanaethau
II.1.4) Disgrifiad byr
This Lotted Term Framework is required in order to provide a quick route to market for smaller clinical trials being conducted by Tayside Clinical Trials Unit (TCTU) in respect of the management and manufacture of research drugs, including (as necessary) over-labelling, storage and distribution , and trial monitoring services
II.1.5) Cyfanswm gwerth amcangyfrifedig
Gwerth heb gynnwys TAW: 1 000 000.00 GBP
II.1.6) Gwybodaeth am lotiau
Mae’r contract hwn wedi’i rannu’n lotiau:
Ydy
Gellir cyflwyno tendrau ar gyfer uchafswm nifer o 7 lotiau
Rhif y Lot 1
II.2.1) Teitl
Manufacture of Trial Drugs
II.2.2) Cod(au) CPV ychwanegol
33600000
II.2.3) Man cyflawni
Cod NUTS:
UK
Prif safle neu fan cyflawni:
Could be anywhere in UK or overseas depending on clinical trial
II.2.4) Disgrifiad o’r caffaeliad
Supply and/or Manufacture of Clinical Trial drugs on a project by project basis (service provider(s) will be appointed via Mini Competition under the relevant Lot of the Framework)
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: 1. Project Management & Communication
/ Pwysoliad: 8
Maes prawf ansawdd: 2. Randomisation & Drug Management
/ Pwysoliad: 8
Maes prawf ansawdd: 3. Manufacture of IMP/Placebo
/ Pwysoliad: 8
Maes prawf ansawdd: 4. Audit Control & Record Keeping
/ Pwysoliad: 4
Maes prawf ansawdd: 5. Experience of Servicing Similar Contracts
/ Pwysoliad: 8
Maes prawf ansawdd: 6. Business Continuity/Disaster Recovery Plan
/ Pwysoliad: 4
Price
/ Pwysoliad:
60
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 24
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
Option to extend framework for 2 x 12 months after initial 2 year term, subject to satisfactory performance and ongoing need.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Na
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 2
II.2.1) Teitl
Over-labelling Services (Labelling & Secondary Packaging)
II.2.2) Cod(au) CPV ychwanegol
79824000
II.2.3) Man cyflawni
Cod NUTS:
UK
Prif safle neu fan cyflawni:
Determined on a project by project basis.
II.2.4) Disgrifiad o’r caffaeliad
Provision of Over-labelling Services (Labelling & Secondary Packaging) in support of smaller clinical trials being conducted by Tayside Clinical Trials Unit (TCTU), University of Dundee.
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: Project Management & Communication
/ Pwysoliad: 8
Maes prawf ansawdd: Proposed Labelling Methodology for IMP and Placebo
/ Pwysoliad: 8
Maes prawf ansawdd: Proposed methodology for secondary packaging of Trial drug
/ Pwysoliad: 8
Maes prawf ansawdd: Experience of Servicing Similar Contracts
/ Pwysoliad: 8
Maes prawf ansawdd: Audit Control and Record Keeping
/ Pwysoliad: 4
Maes prawf ansawdd: Business Continuity/Disaster Recovery Plan
/ Pwysoliad: 4
Price
/ Pwysoliad:
60
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 24
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
2 x 12 months, subject to satisfactory performance by the appointed service provider(s) and ongoing need.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Na
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 3
II.2.1) Teitl
Storage of Research Drugs
II.2.2) Cod(au) CPV ychwanegol
63120000
II.2.3) Man cyflawni
Cod NUTS:
UK
Prif safle neu fan cyflawni:
Dependent on on the location of the appointed service provider(s) and clinical trial location
II.2.4) Disgrifiad o’r caffaeliad
Lot 3 of the Framework - Storage
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: Project Management & Communication
/ Pwysoliad: 8
Maes prawf ansawdd: Storage Facility Size and Location
/ Pwysoliad: 8
Maes prawf ansawdd: Temperature Control
/ Pwysoliad: 8
Maes prawf ansawdd: Experience of Servicing Similar Contracts
/ Pwysoliad: 8
Maes prawf ansawdd: Audit Control and Record Keeping
/ Pwysoliad: 4
Maes prawf ansawdd: Business Continuity/Disaster Recovery Plan
/ Pwysoliad: 4
Price
/ Pwysoliad:
60
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 24
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
2 x 12 month extensions, subject to satisfactory performance and ongoing need.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Na
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 4
II.2.1) Teitl
Distribution of Trial Drugs and Placebos to UK and/or international sites
II.2.2) Cod(au) CPV ychwanegol
60000000
II.2.3) Man cyflawni
Cod NUTS:
UK
Prif safle neu fan cyflawni:
Dundee, but trial sites could be anywhere in the UK and potentially overseas.
II.2.4) Disgrifiad o’r caffaeliad
This Lot relates to the distribution of Clinical Trial Drugs to participating UK and/or international trial sites.
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: Project Management & Communication
/ Pwysoliad: 8
Maes prawf ansawdd: Available Fleet for distribution of trial drugs to UK and/or international trial sites.
/ Pwysoliad: 8
Maes prawf ansawdd: Audit Control and Record Keeping
/ Pwysoliad: 8
Maes prawf ansawdd: Experience of Servicing Similar Contracts
/ Pwysoliad: 8
Maes prawf ansawdd: Business Continuity/Disaster Recovery Plan
/ Pwysoliad: 8
Price
/ Pwysoliad:
60
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 24
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
2 x 12 months, subject to satisfactory performance and ongoing need by the University.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Na
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Ydy
Disgrifiad o’r opsiynau:
2 x 12 months, subject to satisfactory performance and ongoing need by the University.
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
II.2.14) Gwybodaeth ychwanegol
Foe detailed information, please see attached tender documents.
Rhif y Lot 5
II.2.1) Teitl
Importation of Research Drugs
II.2.2) Cod(au) CPV ychwanegol
79824000
II.2.3) Man cyflawni
Cod NUTS:
UK
Prif safle neu fan cyflawni:
Based in Dundee but could have Clinical Trial Sites across the UK and/or abroad.
II.2.4) Disgrifiad o’r caffaeliad
Lotted Term Framework for the Management and manufacture of Research Drugs.
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: Project Management & Communication
/ Pwysoliad: 8
Maes prawf ansawdd: Proposed Methodology for over-labelling importation of Research Drugs importa
/ Pwysoliad: 8
Maes prawf ansawdd: Experience of Servicing similar contracts
/ Pwysoliad: 8
Maes prawf ansawdd: Audit Control and Record Keeping
/ Pwysoliad: 8
Maes prawf ansawdd: Continuity/Disaster Recovery Plan
/ Pwysoliad: 8
Price
/ Pwysoliad:
60
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 24
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
2 x 12 month extension(s), subject to satisfactory performance an ongoing need.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Na
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 6
II.2.1) Teitl
QP Release
II.2.2) Cod(au) CPV ychwanegol
73110000
II.2.3) Man cyflawni
Cod NUTS:
UK
Prif safle neu fan cyflawni:
Dundee but could have sites all over the UK and potentially overseas dependent on the trial.
II.2.4) Disgrifiad o’r caffaeliad
Lotted Term Framework for the management and manufacture of research drugs including over-labelling, storage and distribution to trial sites, and trial monitoring services
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: Project Management & Communication
/ Pwysoliad: 8
Maes prawf ansawdd: Proposed Methodology for QP release
/ Pwysoliad: 8
Maes prawf ansawdd: Experience of servicing similar contracts
/ Pwysoliad: 8
Maes prawf ansawdd: Audit Control and Record Keeping
/ Pwysoliad: 8
Maes prawf ansawdd: Business Continuity /Disaster Recovery Plan
/ Pwysoliad: 8
Price
/ Pwysoliad:
60
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 24
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
2 x 12 months subject to satisfactory performance and ongoing need.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Na
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Rhif y Lot 7
II.2.1) Teitl
Trial Monitoring Services
II.2.2) Cod(au) CPV ychwanegol
73110000
II.2.3) Man cyflawni
Cod NUTS:
UK
Prif safle neu fan cyflawni:
Based in Dundee but trials could be anywhere in the UK and/or overseas.
II.2.4) Disgrifiad o’r caffaeliad
Lot 7 relates to Trial Monitoring Services for any Clinical trials that may require them.
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: Project Management & Communication
/ Pwysoliad: 8
Maes prawf ansawdd: Preparation of Plan of Activity to Deliver Sponsor Monitoring Plan
/ Pwysoliad: 8
Maes prawf ansawdd: Audit Control & Record Keeping
/ Pwysoliad: 8
Maes prawf ansawdd: Experience of Servicing Similar Contracts
/ Pwysoliad: 8
Maes prawf ansawdd: Business Continuity/Disaster Recovery Plan
/ Pwysoliad: 8
Price
/ Pwysoliad:
60
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 24
Gall y contract hwn gael ei adnewyddu: Ydy
Disgrifiad o’r adnewyddiadau:
2 x 12 month extensions after initial 2 year term, subject to satisfactory performance and ongoing need.
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Na
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
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=740555.
The buyer has indicated that it will accept electronic responses to this notice via the Postbox facility. A user guide is available at https://www.publiccontractsscotland.gov.uk/sitehelp/help_guides.aspx.
Suppliers are advised to allow adequate time for uploading documents and to dispatch the electronic response well in advance of the closing time to avoid any last minute problems.
Download the ESPD document here: https://www.publiccontractsscotland.gov.uk/ESPD/ESPD_Download.aspx?id=740555