A professional who has the best knowledge of local laws and practices, who can harmonize needs and interests of multiple parties, turn ‘no’ into ‘yes’, a person who is very often between hammer and anvil – all these statements can perfectly describe a contract negotiator’s role.

Across the industry we sometimes evidence some undervaluation of this role. There are still companies making contract negotiations the responsibility of Clinical Research Associates (CRAs), others delegate contract negotiations to other Start-up Associates.

In practice such delegation has a ‘time-bomb’ effect – in general it is possible to execute a Clinical Trial Agreement (CTA) by efforts of ‘non-contracts’ staff, all issues arise later on when CTA becomes a burden for successful performance of the study due to errors in vitally important CTA clauses resulting in delayed payments, failures in patient recruitment and treatment, poor protection of Sponsor’s rights to the study data and so on, not to mention general reputation consequences.

Back in 2012 CenterWatch conducted a survey resulted in 534 questionnaires completed by the sites and organizations involved into clinical trials conduct in the US and Europe. Interesting that 9% of the respondents stated their companies suffered damages due to improper CTA contents, 6% confirmed they were involved into legal suit or action due to the same reason.

Thus, involvement of local contract professionals into CTA negotiations appear to be a must-have for successful study conduct and mitigation of possible reputation and financial risks.