Clinical Trial Agreement Negotiation

Effective negotiation of contracts are seen as essential part of the trial process, as the sites are undoubtedly the key element in the performance of clinical trials. Our contract negotiation and consultant services include:

  • Contract negotiation planning
  • Effective time management and regular reporting of progress updates to Sponsors/CROs
  • Drafting, developing and review of research site clinical study contracts/agreements (CTA) – Institution, Investigator or any auxiliary contracts, such as pharmacy, radiology agreements, etc.
  • CTA adaptation in accordance with applicable local legislation and GCP rules
  • Sponsor specific language wording incorporation and advisory activity
  • Site specific language incorporation based on broad experience arising from multiple CTA negotiations with the majority of sites within Asia Pacific including Australia & New Zealand
  • Intimate knowledge of site individual requirements and internal rules and arrangements
  • Preparation and review of authorization letters, indemnification letters and other relevant contractual documents
  • Translation of any/all legal contractual documents
  • Management of information system and contract tracking system
  • Support during the regulatory phase of clinical studies
  • Promptness and effectiveness in solving any unexpected development
  • Consulting and supporting role in the CTA execution phase.