Contract negotiation in clinical trials is a very creative and many-sided process. It may be not that evident – some say, what is the difficulty to populate the template with site-specific information, add the budget, negotiate in accordance with the pre-setup parameters – and that’s it. If that statement is correct, then why Pharmas and CROs have separate site contracts departments?

Previously we already spoke about the negotiator’s role, now let’s see how the negotiator is integrated into the study team.

Practice demonstrates that successful negotiations is very often the result of the efficient teamwork.

The model where the negotiator is not integrated into the start-up and clinical teams, acting independently just periodically reporting the negotiation status to the teams, is definitely not ideal. Companies utilising such model often face issues with long negotiation timelines and poor quality of final clinical trial agreements, especially in terms of budget, that results in site activation, study drug supply and site payments delays, not mentioning general reputation risks.

Healthy work environment is when the negotiator is fully integrated into start-up and clinical teams. Only team effort is a key to success.

Real life example: during budget negotiations site asks contracts specialist if magnesium is included into laboratory parameters as the fee depends on it. What options the negotiator (not being a clinical professional) has to respond to the site?

Option 1. Read through the protocol and laboratory manual, ensure there is no mentioning of ‘magnesium’, go back to the site confirming that magnesium is not included.

Option 2. Forward site’s request to CRA or PM, stating that the query is beyond the competence of the negotiator.

So basically the above options mean either taking full responsibility or shifting responsibility to others. Both options don’t seem to be the right choice. Professional negotiator would first try to find the answer, then confirm with the clinical team if the answer is correct.

Professional negotiator will never use I-can-do-it-solely-by-myself or this-is-beyond-my-competence approach. Professional negotiator shall always find the balance. Addressing the clinical team with: “Guys, I looked through the lab manual and didn’t find magnesium in the list of parameters (page XX of the manual), will you please confirm if this parameter is not applicable for our study?” – would be an example of the professional behaviour.

Thus our message to the negotiators: be balanced and never hesitate to ask the team if you are not sure about some clinical aspect. Negotiation is a teamwork and professional negotiator should always be in touch with clinical and start-up teams not only providing updates, but also counting on reasonable support.