Clinical Trials Law
Taking into consideration the vital importance of ensuring the legal security of scientific advancements in the fields of medicine and pharmacology, protecting human health, and navigating strict regulations in the pharmaceutical/medical device sector, our firm provides professional legal consultancy and advocacy services to its clients in the field of Clinical Trials Law. Safeguarding client privacy, observing bioethical rules, protecting trade secrets, and adherence to legal ethics are our core principles throughout these processes.
We are fully aware of the massive criminal, administrative, and financial devastation that clinical trial disputes and allegations of regulatory non-compliance can inflict on research companies (sponsors), Contract Research Organizations (CROs), hospitals, and volunteers (subjects). Accordingly, our objective is to resolve disputes fairly, effectively, and as swiftly as possible within the framework of Good Clinical Practice (GCP) guidelines, Turkish Medicines and Medical Devices Agency (TİTCK) legislation, and international regulations, while strictly safeguarding our clients’ best interests.
The primary services we offer in the field of Clinical Trials Law include: • Administrative and legal management of TİTCK and Ethics Committee application, approval, and objection processes • Drafting and negotiating Clinical Trial Agreements (CTA) among the sponsor, Contract Research Organization (CRO), and the investigator (hospital/physician) • Conducting legal reviews of volunteers’ informed consent forms for compliance with national and international legislation (Declaration of Helsinki) • Tracking material/moral compensation and recourse lawsuits arising from adverse events (side effects) and complications occurring in clinical trials • Managing KVKK and GDPR compliance processes within the scope of the processing and international transfer of sensitive personal health data • Providing effective criminal defense in Heavy Penal Courts against allegations of unauthorized or unlawful human experiments (TCC Art. 90) • Filing stay of execution and annulment lawsuits in Administrative Courts against decisions to halt, suspend, or revoke licenses of clinical trials • Resolving intellectual property disputes arising from R&D, licensing, patent, and technology transfer contracts of pharmaceuticals and medical devices • Managing financial disputes arising from clinical trial budgets, national/international fund, and grant agreements (TÜBİTAK, EU funds, etc.) • Creating legal risk analyses and regulatory defense strategies in cases of protocol deviations emerging during research