Smart Start Services: Budget and Contract Negotiations

Poorly negotiated clinical trial agreements (CTAs) and budgets expose research institutions to significant financial risk and hardship. This problem is further exacerbated due to insufficient staff, minimal expertise, and shortened study start-up timelines.

PFS Clinical can secure equitable budget and contract conditions for your clinical trials.


Benefits of Budget and Contract negotiations 

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Allow site personnel more time to focus on clinical activities

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Maximize study budgets using favorable payment terms

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Rapid turnaround of contract and budget review

 
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Limit your exposure from complex contract language

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Identify and secure additional funds that are often not initially offered by sponsors

 

Budget and Contract Negotiation Process

  1. PFS Clinical contract manager interviews the institution to get an understanding of their risk profile and payment term expectations
  2. Institution provides contract manager with the study CTA, sponsor budget, lab manual, etc.
  3. Contract manager reviews the CTA and red-lines the desired changes with supporting rationale
  4. Budget manager reviews the study protocol to build an inclusive, detailed activity grid
  5. PFS Clinical manager negotiates red-lined CTA and budget changes with the sponsor/CRO
  6. Manager facilitates the signature execution and maintains contact for potential amendments

Additional Smart Start Services:

CTMS Implementation | Coverage Analysis