Electronic Trial Master File (inc. Electronic Archiving)

Description

The Southampton Clinical Trials Unit (SCTU) requires an electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) and eArchiving solution that meets regulatory requirements (including Eudralex Vol4 annex 11 for computerized systems). These solutions should follow the ALCOA+ principles (Attributable, legible, contemporaneously recorded, original or a true copy, accurate, complete, consistent, enduring, and available). Documents should be able to be approved with fully regulatory compliant e-signatures. The University requires data to be retrievable, along with all metadata, for up to 30 years. The SCTU expects 4-6 new trials a year, and 25 trials recruiting at any one time. E-Tendering Portal: The University is utilizing an electronic tendering tool, In-Tend (https://in-tendhost.co.uk/universityofsouthampton/aspx/Home) to manage this procurement and to communicate with potential tenderers. All documentation in relation to this tender can be downloaded from In-Tend. Potential tenderers are advised that there will be no hard copy documents issued and all communications with the University, including the submission of Selection Stage and/or Invitation to Tender responses will be conducted via In-Tend. Regular monitoring of the portal is the responsibility of the potential tenderer. If you are not already registered as a supplier with the University of Southampton, you will need to register in In-Tend in order to access the procurement documentation. Once you have logged in as a supplier: click on 'Tenders'; locate the relevant project; and click 'View Details'. Once you are in the project screen, you will be able to register your organisation against the project and access all documentation by clicking 'Express Interest'. Potential suppliers/tenderers are advised that formal expressions of interest in the project must be by way of completion and return of the relevant documents via In-Tend. Further instructions for the submission of responses are below: To submit your return: 1. Log in 2. Click 'Tenders' 3. Locate the relevant project 4. View details 5. Click on the tab relating to the relevant project stage (e.g. 'Invitation to Tender') 6. Click on the 'Attach Documents' button and upload your return. 7. Check ALL your response documents are uploaded and displayed in the 'My Tender Return' panel. The system will only permit your organisation to make one return. 8. Click the red 'Submit Return' button. Please note, to preserve the integrity of the procurement, all communications with the University must be made via the correspondence function within In-Tend. The University is not liable for any costs in the event of the cancellation of this procurement process. Additional information: E-Tendering Portal: The University is utilizing an electronic tendering tool, In-Tend (https://in-tendhost.co.uk/universityofsouthampton/aspx/Home) to manage this procurement and to communicate with potential tenderers. All documentation in relation to this tender can be downloaded from In-Tend. Potential tenderers are advised that there will be no hard copy documents issued and all communications with the University, including the submission of Selection Stage and/or Invitation to Tender responses will be conducted via In-Tend. Regular monitoring of the portal is the responsibility of the potential tenderer. If you are not already registered as a supplier with the University of Southampton, you will need to register in In-Tend in order to access the procurement documentation. Once you have logged in as a supplier: click on 'Tenders'; locate the relevant project; and click 'View Details'. Once you are in the project screen, you will be able to register your organisation against the project and access all documentation by clicking 'Express Interest'. Potential suppliers/tenderers are advised that formal expressions of interest in the project must be by way of completion and return of the relevant documents via In-Tend. Further instructions for the submission of responses are below: To submit your return: 1. Log in 2. Click 'Tenders' 3. Locate the relevant project 4. View details 5. Click on the tab relating to the relevant project stage (e.g. 'Invitation to Tender') 6. Click on the 'Attach Documents' button and upload your return. 7. Check ALL your response documents are uploaded and displayed in the 'My Tender Return' panel. The system will only permit your organisation to make one return. 8. Click the red 'Submit Return' button. Please note, to preserve the integrity of the procurement, all communications with the University must be made via the correspondence function within In-Tend. The University is not liable for any costs in the event of the cancellation of this procurement process.