Knowledge Center for Clinical Research in Turkey

Your Guide to Clinical Research in Turkey - Knowledge Center

For international sponsors, the “Holy Grail” of clinical research is finding high-quality data, fast recruitment, and optimized costs in one location. Turkey offers exactly this combination. With a population of over 85 million and a centralized healthcare infrastructure, Turkey has established itself as a regional powerhouse for clinical trials.

1. Comprehensive Therapeutic Expertise
Turkey’s centralized healthcare system offers unique advantages across a wide spectrum of therapeutic areas. While CROTURK has deep expertise in complex fields like Oncology and Rare Diseases, the high patient volume in Turkish hospitals makes it an ideal location for large-scale studies in:

Metabolic Diseases (Diabetes, Obesity)
Respiratory (COPD, Asthma)
CNS & Neurology (Alzheimer’s, MS, Epilepsy)
Infectious Diseases & Dermatology

Whether your study requires a niche patient population or thousands of patients for a chronic disease trial, our investigator network covers all major medical disciplines.

2. Quality & Compliance
Turkey is not an “emerging” market in terms of quality; it is an established one. The Turkish Ministry of Health (TİTCK) is an active member of the ICH (International Council for Harmonisation). All trials are conducted in strict accordance with ICH-GCP guidelines, ensuring that data generated here is accepted by the FDA (USA) and EMA (Europe).

3. Cost-Efficiency Without Compromise
While maintaining EU-level quality standards, operational costs in Turkey remain significantly lower than in the US or Western EU. Faster recruitment rates also mean shorter trial durations, leading to substantial budget savings for sponsors.

Conclusion
Turkey is no longer just an alternative; it is a strategic necessity for global studies.

Whether you need a rescue country for a stalled trial or a primary location for a new study, Turkey delivers.

Navigating the TITCK Regulatory Landscape

Understanding the approval process, timelines, and requirements for conducting clinical trials in Turkey.

The Authority: TİTCK Clinical trials in Turkey are regulated by the Turkish Medicines and Medical Devices Agency (TİTCK). The Agency is known for its strict adherence to international standards and its predictable review timelines. Understanding their workflow is key to a successful start-up.

The Sequential Submission Process

Unlike some jurisdictions that allow parallel review, Turkey follows a sequential approval process:

1. Ethics Committee (EC) Approval: The application must first be submitted to and approved by the relevant Clinical Research Ethics Committee.

2. Ministry of Health (MoH) Approval: Once the EC approval is secured, the dossier is submitted to TİTCK for final authorization.

Competitive Timelines Despite the sequential nature of the process, the total timeline remains highly competitive.

• Average Timeline: 3 to 4 months (from initial submission to final site activation).

• CROTURK Strategy: We prepare both EC and MoH dossiers simultaneously. The moment EC approval is received, we submit to the MoH immediately, eliminating downtime.

Document Requirements TİTCK is pragmatic regarding documentation. Core scientific documents (Protocol, Investigator’s Brochure) are accepted in English. Only patient-facing documents (ICF) and application forms require Turkish translation.

Conclusion Navigating TİTCK requirements demands local expertise.

With the right partner, the regulatory pathway in Turkey is smooth, transparent, and fast.

Medical Device Investigations under EU-MDR in Turkey

The transition to the Medical Device Regulation (EU) 2017/745 (MDR) has created a massive demand for high-quality clinical data. Manufacturers face a bottleneck: finding sites that can perform clinical investigations or PMCF (Post-Market Clinical Follow-up) studies quickly enough to maintain market access.

Turkey: Fully Aligned with EU-MDR Turkey acts as a natural extension of Europe for medical device trials. The country has fully harmonized its legislation with the EU-MDR. Clinical data collected in Turkish sites is valid for conformity assessments by Notified Bodies across Europe.

Why Choose Turkey for Device Trials?

High Surgical Volume: Turkish surgeons in reference hospitals perform a high volume of procedures daily. This allows for rapid validation of surgical tools, implants, and diagnostic devices.
ISO 14155 Compliance: All device investigations are conducted under strict ISO 14155 standards (Good Clinical Practice for Medical Devices).
Speed: With waiting lists for elective surgeries growing in the EU, Turkey offers immediate access to patient cases.

CROTURK’s MedTech Expertise We specialize in bridging the gap between engineering and clinical evidence. From usability studies to large-scale pivotal trials, we manage the entire lifecycle of device validation.

Conclusion Don’t let the clinical data gap delay your CE certification.

Turkey offers the speed and volume you need to satisfy your Notified Body.