Negotiating Clinical Trial Agreements is not an easy task, especially when dealing with huge multi-center and multi-country study. A lot of key players are involved into the process: negotiators, Sponsor or CRO’s clinical and start-up teams, contract managers, legal advisors etc.

It is essential to build up a clear and well-working communication paths between all stakeholders. Sounds self-evident, however the practice demonstrates that quite often the communication falters at some time point that leads to errors, misunderstandings, and delays in contract finalisation.

Let’s review when and why the communication may go wrong.

⁃ Non-responsiveness or slow responsiveness of the site. This is a very popular trigger for the communication to fail. CROs and Sponsors are eager to activate the sites as soon as possible, and often they start panicking when the contract negotiation is stuck in site’s unresponsiveness, and instead of consulting the local negotiator and developing some action plan together, Sponsor starts to push the site in parallel with CRO and the negotiator – this will hardly lead to the good result. Some tips on how to tackle unresponsiveness can be found in our previous article.

⁃ Lack of understanding of the current negotiation status. If the Sponsor/CRO are not sure what is going on with the contract negotiation, they may go to the site directly to understand the status asking the site the questions that were probably already asked and even answered. Proper tracking is the solution to avoid this.

⁃ Prioritisation of speed over the quality. Sponsor/CRO being copied in the negotiator’s correspondence with the site may jump in not giving the local negotiator an opportunity to action. This often happens at the final stage of negotiation when the site confirms they agree to the latest version of the contract, which is treated by the Sponsor/CRO as the green light to start signature process, regardless quality check is performed by the local negotiator or not. Skipping the QC may result in negative consequences.

These are only a few examples of when the communication may go wrong. Contract negotiation being always a team work should have a very well established communication or project plan, since team work doesn’t mean that all team members do one and the same job, but everyone’s function shall be respected. As people say, ‘too many cooks spoil the broth’.