Site Contracts negotiations can sometimes feel like they were designed to cause headaches. The best plans of the most experienced project trial team can quickly be tested by an unexpected budget dispute, an esoteric legal issue, or the absence of a seemingly mundane bit of site documentation needed to finalize some element of a site’s clinical trial agreement. Worse still, the process of working to resolve an issue during site contract negotiations often seems to be an impossible task—with the right decision-maker or the necessary information just out of reach while precious time on a study is lost.
Contracts negotiation does take time as well, and unexpected issues do frequently limit how quickly the entire startup process can be completed. A delay in the contract management step can threaten to extend the timelines for activations across multiple sites. Since any delay in the startup phase can impact patient enrollment, it’s no stretch to say that a misaligned approach to site contracts can jeopardize a team’s ability to meet its study’s milestones.
If the process seems cumbersome, then it might actually be. At Syneos Health, we know that negotiation of a site contract is a relatively simple process, which often has an incredibly high number of unintentional complications. With multiple stakeholders requiring review, legal policies and risk profiles; as well as scientific committee reviews to navigate and escalation hand-offs for approval documentation—there is a wide range of sources where complications can arise during a negotiation. This is why so many Sponsors have entrusted Syneos Health to build a dedicated team with customized tools and processes to provide functional site contracts management services in alignment with their unique R&D strategies and needs. We can help to streamline negotiations and ensure that contract and budget executions are no longer the ratelimiting factor in how quickly patient enrollment can begin.
From the protection of confidential information, to the liability of both parties, and the financial arrangements for the cost of the study’s conduct, a clinical trial agreement covers all of the elements of the study, and the investigator’s participation hinges on it.
Hashing out the details of the contract involves:
- Gaining agreement from multiple parties. Multiple disciplines from multiple entities are involved in discussing, reviewing and approving study contracts, such as financial, legal, clinical functions, study sponsor/site, Contract Research Organizations (CROs), ethics/review committees, among others.
- Answering questions about the protocol. The contract’s budgetary review is the first real test of the study design and the protocol itself. Sites interpret the activities outlined on the study from a financial perspective and ask for clarification, etc. This takes time and coordination between negotiators and clinical teams.
- Negotiating over grant amounts. The vast majority of delays in gaining agreement on contract terms relates to negotiations over grant amounts rather than over other contract terms and legal language. Sites rarely accept the first offer that is made to them. Negotiations typically become very granular and nuanced as the site and sponsor work together to agree on reimbursement for specific procedures of the protocol (i.e., costs for procedures such as EKG or blood draw; costs for administrative duties such as record archiving, study set up, team training).
- Having a global footprint for global studies. Managing contracts for global studies necessitates having “feet on the ground” in those countries where the study will be conducted. Negotiations can take place using the local language within the time zone and with knowledge of local conditions and practices.
- Navigating the tensions between corporate and study-level concerns. Contracts contain elements that must be decided upon by various stakeholders (legal, financial and clinical), sponsors and CROS who may not be study-level staff. The staff assigned to the study site (who may or may not have legal/budgetary expertise), must then seek the same level of guidance from their internal stakeholders as compromises are sought. The availability and flexibility of the various decision makers increases the administrative complexity of conducting a negotiation.