Product/Service

Contracts And Legal

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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.

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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)

inSeption Group