Our company has successfully negotiated and executed over 5000 clinical trials contracts.
Effective negotiation of contracts may be deemed 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 Czech 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 Czech Republic
- Intimate knowledge of site individual requirements and internal rules and arrangements
- Preparation and review of authorization letters, indemnification letters, powers of attorney and other relevant contractual documents
- Negotiation process execution
- Sponsor fallback document system application
- 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 developments
- Consulting and supporting role in the CTA execution phase.