Clinical trials are often conducted and managed by the collaboration of many different organisations, including the sponsor, contract research organisation and site. Therefore, it is important for each party involved in a study to be clear of what is expected of them. As part of the start-up process for a clinical trial, it is essential to have a Clinical Trial Agreement in place prior to the commencement of any clinical study.

Clinical Trial Agreement, also referred to as CTA, is a main legally binding agreement governing the conduct of a clinical study. It manages the relationship between the pharmaceutical company sponsor of the study and the institution/site that enrols the study participants. The site agrees to use its good faith efforts to conduct the study in accordance with the site policy, study protocol, applicable laws and regulations. The sponsor agrees to engage the services of the site to conduct the study and further agrees to provide the site with the study material including the drug to be tested.

The sponsor carries majority of the risk and is therefore required to have adequate insurance in place. In addition to the details of insurance, a CTA will also specify the terms of collaboration of each party, study participants’ injury coverage, guidelines for dispute resolution, and grounds for termination or amending contract terms.

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Only a handful of countries specifically mention clinical trials in insurance law, meaning it is very difficult to find vital compliance and regulatory information. That is why Axco developed a central resource for clinical trials, covering over 170 territories.