Site contract and negotiation

 

Negotiating study contracts and budgets is critical point for future progress of every clinical study. Convex contract specialists have thorough understanding

of the contract process including contract development evaluation, negotiation, approval, tracking, and execution. We manage a high volume of clinical

contracts with a specific focus on country-specific templates including investigator/institutional, pharmacy, laboratory and other vendor’s agreement necessary

to conduct study in Bulgaria. We are responsible for:

 

  • Drafting, adapting, translating and implementing clinical research contracts
  • Negotiating contracts and budgets within pre-set parameters
  • Developing study budget
  • Identifying any hidden costs
  • Evaluating compliance with contractual requirements for all clinical investigations
  • Preparing original site and vendor contracts
  • Working with Sponsor/CRO team during the negotiation process
  • Ensuring timelines are met in an efficient manner
  • Acting as a liaison between Sponsor, CRO, sites and vendors
  • Tracking and overseeing clinical investigator/hospital institution contracts status, including payments, and driving effective contracting process.

 

For the purpose of the study approval process by the RA and EC only draft contracts are required. However, prior to the date of a site initiation visit all relevant 

contracts shall be signed by all parties involved in the process. The time for contract finalization differs among clinical sites, however, it is between 1 – 4 weeks.