SUBMIT REQUEST FOR A NEW AGREEMENT
Our web-based ‘Research Information Form’ must be submitted to request a clinical study agreement and/or an agreement with hospital pharmacy, to Inven2. Submission of the form, including necessary documents, initiates the agreement and budget process at Inven2, the hospital/site and the hospital pharmacy. One form must be submitted per site/hospital pharmacy.
Guide to the notification form and information on the process
Who should submit the study?
Sponsor or CRO is responsible for submitting the study to Inven2.
When should the study be submitted?
As soon as participation in the study at the site is confirmed by Sponsor/CRO and the protocol is finalized.
To ensure rapid progress, the request for agreement(s) must be submitted to Inven2 at the same time as the study is submitted to CTIS/Regulatory Authorities/EC.
What should be registered in the notification form?
All fields marked with red in the form, and fields for other relevant information, must be filled in. Fields that are not relevant shall be marked with «NA».
Please note that the agreement and budget processes depend on the provision of sufficient and accurate information in the form, and attachment of necessary documents.
Which documents must be attached to the notification form?
Study protocol (electronic version):
Submission of the study protocol is mandatory. Inven2 will not initiate the agreement and budget process until the final version of the study protocol is ready.
If the protocol is updated during the process, the latest version must be sent to Inven2 without delay.
Draft Study Budget:
Submission of the draft study budget is mandatory. Inven2 will not initiate the agreement and budget process until a draft budget is provided.
Which documents may be sent after submission of the notification form?
Operational manuals (lab, radiology, pathology, etc.):
Several of the departments that perform various procedures will not be able to provide feedback on capacity and price until the manual(s) is (are) available.
Draft agreement:
A proposal for a clinical study agreement can be sent later if it is not ready when the study is submitted.
Other:
Other documents or information that can be of help to Inven2 in the agreement process should be submitted.
Involvement of hospital pharmacy
If a hospital pharmacy shall deliver services, Sponsor/CRO must provide necessary information in the form. For more information about the agreement process relating to the hospital pharmacy, see here.
Processing times at Inven2
The sender will receive an automatic e-mail once the notification form has been submitted.
Within seven days, Sponsor/CRO’s contract negotiator will receive an e-mail with the following information:
- Reference number: Each study will be given a unique project number (M number). This reference must be used in all subsequent correspondence with Inven2 regarding the study, agreement and invoicing
- Name and contact details of Inven2’s contract manager
- Information about further process in relation to budgeting, study agreement and pharmacy agreement
Within seven days of registered receipt of the completed notification form, Inven2 will send information about the budget process and a study-specific document for budgeting to the investigator and the study team at the hospital/site.
Within fourteen days of receiving the agreement proposal from Sponsor/CRO, Inven2 will provide feedback on the legal text of the agreement.
For questions regarding the form, contact; kliniskgruppe@inven2.com.
