Clinical Trial Agreements and Legal Support in Georgia
Georgia is becoming increasingly attractive for international pharmaceutical companies to conduct clinical trials. This is due to regulatory transparency and the presence of qualified medical personnel. However, a clinical trial is a highly complex legal process requiring the balancing of multiple interests: the sponsor's commercial interests, the research center's (clinic's) institutional obligations, and, primarily, the safety and rights of the research subject (patient). The Clinical Trial Agreement (CTA) is the main document regulating these relationships and allocating responsibilities among the parties.
Legal.ge offers experienced lawyers specializing in clinical trial law. Through our platform, you can find specialists who provide legal support for the initiation and conduct of trials, from drafting agreements to interacting with ethics committees. This service is critically important for sponsors, Contract Research Organizations (CROs), and medical institutions.
What Does Clinical Trial Agreements Service Cover?
Our specialists offer full legal services in the field of clinical trials:
- Agreement Drafting and Negotiation: Drafting tripartite (Sponsor-CRO-Clinic) and bilateral agreements (CTAs), covering budget, responsibilities, and intellectual property.
- Investigator Contracts: Concluding employment or service agreements with the principal investigator and the research team.
- Informed Consent Forms (ICF): Adapting consent forms for research subjects in compliance with Georgian legislation and ethical norms.
- Regulatory Interaction: Submitting documentation to the Regulation Agency for Medical Activities to obtain trial permits.
- Data Protection (GDPR/Local Law): Ensuring legal mechanisms for protecting the personal data of trial participants.
- Insurance Agreements: Legal review of health and life insurance contracts for research subjects.
Common Situations and Scenarios
One common difficulty is the allocation of intellectual property rights. The sponsor wants full rights to trial results, while the clinic or university may request rights to academic publications. A lawyer helps parties find phrasing that protects trade secrets but does not restrict academic freedom.
Another scenario relates to patient health injury during the trial. If a patient develops an adverse event, the issue of compensation arises. A well-drafted agreement and insurance policy precisely define who pays compensation — the sponsor or the insurance company, protecting the clinic and doctor from unforeseen financial losses.
Georgian Legislation and Legal Framework
Clinical trials in Georgia are regulated by the Law of Georgia on Medicines and Pharmaceutical Activities (Chapter on Clinical Trials) and the Law on Health Care. Conducting a trial requires a permit issued by the Regulation Agency based on a positive conclusion from an Ethics Committee. The process must comply with Good Clinical Practice (GCP) international standards, which are recognized by Georgian legislation.
Regarding patient rights protection, the Law on Patient Rights operates, prohibiting experiments on humans without their voluntary, written consent. Personal data protection is ensured by the Law on Personal Data Protection, which is particularly strict regarding health data.
Process of Receiving Services
The process begins with a request from a sponsor or CRO. A Legal.ge lawyer checks the trial protocol and prepares the initial version of the agreement for the clinic. Parallel work is done on the insurance policy and informed consent form. After negotiations conclude, the lawyer compiles the full package for submission to the regulator and ensures the permit is obtained. During the trial, the lawyer continues support in case of amendments to the agreement or disputes.
Legal.ge experts ensure that your clinical trial proceeds smoothly, in full compliance with ethical norms and the law, which is essential for the international recognition of the obtained data.
Why Choose a Specialist on Legal.ge?
Clinical trial law requires knowledge of English, medical terminology, and international regulations (FDA, EMA, GCP). Legal.ge gives you access to lawyers with exactly these qualifications. Specialists found with us will help you minimize risks and effectively manage the trial process.
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