Negotiation of agreements
Inven2 is responsible for the negotiation of clinical study agreements and other forms of cooperation with industry on behalf of hospitals and investigators. This process comprises both quality assurance of the legal contents and negotiation of price and other conditions with the industy.
Our goal is that this process should be as efficient and predictable as possible.
- You will receive feedback on the legal content of the agreement within 14 days from the date we received the draft agreement
- Inven2 coordinates the agreement signing with the hospital and archives the signed agreement
- Inven2 and the hospitals prefer electronically signing of the agreement. This will significantly shorten the signing process and facilitate faster study initiation.
The agreement itself is a three-part agreement that must be signed by:
- The sponsor or CRO on behalf of the sponsor
- The health trust represented by the head of the department where the investigator is employed
The investigator signs the agreement as ‘read and acknowledged’, but is not a party to the agreement.
The responsibility between the parties to the agreement is as follows:
- Industry: Responsible as Sponsors according to Good Clinical Practice (GCP)
- The health trust: Responsible for the conduct of the study in accordance with GCP, including the investigator responsibility. This includes scientific responsibility, responsibility for the recruitment of patients and the medical follow up of the patients. The Principal Investigator carries out the study as an employee of the health trust
- Inven2: Responsible for contract negotiation and invoicing on behalf of the health trust