Comprehensive Clinical Research Services in Turkey
From Phase I to Post-Market, and from Oncology to Primary Care. CROTURK leverages a nationwide network of sites to conduct clinical trials in every major therapeutic area, ensuring that no matter your indication, we have the experienced investigators ready to start.
Clinical investigations & PMCF studies fully compliant with ISO 14155 and EU-MDR.
e-Clinical Solutions
FDA 21 CFR Part 11 compliant EDC systems and Data Management.
Medical Writing
Protocols, CRFs, and Clinical Study Reports (CSR).
Staffing Solutions
Dedicated CRAs and Study Coordinators for your specific needs.
Clinical Monitoring
Reliable data is the only currency in clinical research. While many CROs treat monitoring as a routine administrative task, Croturk views it as the frontline of risk management. Our clinical operations are built on the principle of "Quality at the Source."
We don't just watch over sites; we manage them. By fostering strong, professional relationships with Turkish investigators and site staff, we ensure high recruitment rates and meticulous data entry. Our monitors are trained to look beyond the CRFs to identify the operational nuances that impact data integrity. Whether through traditional on-site visits or risk-based monitoring strategies, we provide the oversight necessary to ensure your study is audit-ready at any given moment, safeguarding both patient safety and your investment.
Regulatory Affairs
In the Turkish regulatory environment, success isn't just about following the rulebook; it’s about anticipating the shifts within it. At Croturk, we don't just "submit applications." We act as your strategic local representative, bridging the gap between global protocols and TİTCK (Turkish Medicines and Medical Devices Agency) requirements.
Leveraging over two decades of institutional memory, we streamline the path from feasibility to site initiation. We understand that every week saved in the Ethics Committee or Ministry of Health approval process is a week gained for your study’s lifecycle. Our approach is proactive rather than reactive—we identify potential regulatory bottlenecks before they become delays, ensuring your trial starts on a foundation of absolute compliance and tactical speed.
CROTURK supports global sponsors throughout the full study lifecycle in Turkey—from initial feasibility and site strategy through start‑up, conduct, and close‑out.
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Feasibility & Site Strategy
Early feasibility, site intelligence, and country fit assessments to design a realistic and efficient study footprint in Turkey. -
Start‑Up & Regulatory
Coordinated Ethics Committee and TİTCK submissions, contract negotiation support, and site activation planning. -
Conduct & Monitoring
On‑site and remote monitoring, issue management, and ongoing risk‑based oversight to keep data clean and timelines on track. -
Close‑Out & Reporting
Structured close‑out visits, documentation reconciliation, and support for CSR preparation and inspections.
Medical Device (MDR)
CROTURK supports clinical investigations and PMCF activities for medical devices and IVDs in Turkey, aligning global study designs with EU MDR and local TİTCK expectations to build robust, inspection‑ready evidence packages.
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MDR & TİTCK Alignment
Study protocols, patient pathways, and documentation planned to satisfy both MDR requirements and Turkey‑specific regulatory nuances. -
Specialized Site Network
Access to high‑volume hospitals and specialist centers experienced in device and IVD studies, including complex procedures and diagnostics. -
Evidence & PMCF Strategy
Design and execution of clinical investigations and PMCF programs that generate the real‑world and clinical data needed for approvals and lifecycle management.
The transition to Medical Device Regulation (MDR 2017/745) has fundamentally redefined the landscape for manufacturers and sponsors. In this high-stakes environment, compliance is no longer a one-time hurdle but a continuous commitment to clinical safety and technical rigor. At Croturk, we provide the specialized expertise required to navigate this complexity, ensuring that your innovation doesn't just reach the market, but stays there.
We treat MDR compliance as an integrated clinical strategy rather than a mere documentation exercise. From the initial classification of your device to the meticulous preparation of Technical Documentation and Clinical Evaluation Reports (CER), our team acts as your expert liaison. We bridge the gap between engineering and clinical reality, ensuring that your Post-Market Clinical Follow-up (PMCF) plans and Periodic Safety Update Reports (PSUR) are not only compliant with EUDAMED standards but are also operationally sustainable.
In the Turkish and European markets, where regulatory scrutiny is at an all-time high, our 20-year history in clinical research provides a unique advantage. We don't just interpret the law; we apply it through the lens of experience. Whether you are navigating the nuances of "Legacy Devices" or launching a cutting-edge Class III innovation, we provide the regulatory roadmap and the clinical evidence strategy needed to secure and maintain your CE marking.