Clinical research is scientific studies that focus on improving knowledge of diseases and developing new treatments. Clinical researches in Turkey are in compliance with European Union regulations. All clinical research processes are closely monitored by Turkish Medicines and Medical Devices Agency and the Ministry of Health in light of applicable legislation including,
- Regulation on Clinical Trials of Medicinal and Biological Products
- Regulation on Clinical Research for Medical Devices
- Regulation on Clinical Researches on Effectiveness and Safety Studies on Cosmetic Products and their Raw Materials
and guidelines published under these regulations.
Thanks to its vast experience and knowledge in the management of clinical research processes, Bozoğlu İzgi offers services including,
- Clinical research contracts,
- Defining contract parties and their responsibilities,
- Ethical relations with research agencies,
- Ensuring transparency pursuant to statutory regulations in the course of clinical researches,
- Confidentiality of patient data,
- Obtaining required permissions from competent bodies and authorities.
Bozoğlu İzgi’s first and foremost policy is to ensure that very tightly regulated clinical researches are fully compliant with applicable legislation in every single stage. Potential disputes are prevented before they arise. A legal relation is established whereby volunteer rights are safeguarded in line with good clinical practices.
With this intention in mind, Bozoğlu İzgi offers high-quality consultancy services to its clients by
- Drafting statutory form documents,
- Contracts and
- Supporting documentation that meet such criteria sought by the legislation in clinical research processes or by reviewing available documentation and contracts in detail.