Besides site and vendor contracts, other contract types may be required for your (pre) clinical study.
legal review
Review of other contracts & study documents
Specialist contracting
Salvius offers customized and clinical research-specific contracting support, combining knowledge and expertise in (pre-)clinical research. We translate your collaboration structures or research principles into understandable and useful contracts.
Examples of contract types Salvius can draft, review or negotiate:
- Sponsor, CRO or other vendor clinical services agreements
- Licensing agreements
- Consortium agreements
- (Software) licensing agreements
- Material transfer agreements
- Quality agreements
- Data sharing agreements
Examples of study documents that may benefit from legal review:
- Patient informed consent form (PICF)
- Data consent forms
- Letters of delegation or authorization
- Power of attorney
- Legal sections in study protocols
- Steering committee agreements
Legal review of study documents
To comply with applicable laws and regulations, there are certain documents that need to be finalized at the study start-up phase. Although these may be clinical or regulatory documents rather than contractual documents, they may require legal review to ensure legal compliance and sufficient protection.
