Contracts and Legal

We manage all aspects of contract and template development, alternative language and budget parameter development, contract negotiations and execution, as well as investigator grant payment administration and patient reimbursement.

We have both US and ex-US expertise, are able to manage the complexities of study start up timelines and challenges with the negotiation process, and are committed to best practices and reduced cycle times.

Contracting

Sponsor, vendor, and site agreements and payment schedule, template development, and negotiations:
- CDAs, MSAs, and Vendor Agreements
- Clinical Trial Agreements (e.g., Masters, Work Orders and Amendments)
- Ancillary agreements (e.g., laboratory, pharmacy, radiology, coordinating investigator, letters of indemnification, IDMC, clinical supplies)
Alternative language and budget parameter development:
- Initial fallback language/updated as negotiations progress based on trending
- Budget deviation ranges based on Fair Market Value
Agreement and budget tracking
Transparent communications
Execution and filing
Act as an extension of the Sponsor’s legal/contracts department(s)