Who Can Be a Sponsor of a Clinical Trial?
A clinical trial sponsor is an individual, company, institution, or organization responsible for initiating, organizing, financing, and overseeing a clinical trial. The definition of a sponsor is set out in Regulation (EU) No 536/2014 of the European Parliament and of the Council, while clinical investigations of medical devices are governed by the MDR and IVDR regulations. The sponsor is responsible for ensuring compliance with applicable regulations, Good Clinical Practice (ICH GCP), and the safety of trial participants.
Most commonly, the sponsor is a pharmaceutical company conducting research on a new medicinal product or seeking to expand the indications of an already registered medicine. Medical device manufacturers may also act as sponsors when conducting clinical investigations to confirm the safety and performance of their devices.
Sponsors may also include universities, research institutes, hospitals, foundations, and other organizations involved in scientific research. In such cases, the studies are generally non-commercial and aim to advance medical knowledge or evaluate new diagnostic and therapeutic methods. Increasingly, biotech and medtech startups developing innovative medicines, medical devices, or digital solutions are also becoming sponsors.
Regardless of the type of organization, a sponsor should have the financial, organizational, and human resources necessary to conduct the trial properly. Its responsibilities include, among other things, preparing regulatory documentation, obtaining the required approvals, selecting research sites, ensuring trial monitoring, overseeing participant safety, and archiving trial documentation.
A sponsor may delegate some of its responsibilities to a Contract Research Organization (CRO), such as project management, monitoring, data management, or preparation of documentation for regulatory submissions. However, this does not mean that legal responsibility is transferred. Under applicable regulations, the sponsor remains responsible for the proper conduct of the trial and for protecting the rights, safety, and well-being of its participants.
