Clinical investigations
Design, submission and execution of device investigations in Turkish centres, with the same monitoring and data standards as drug studies.
Evidence
Clinical research on site and end to end in Türkiye with Medex SMO and Medex CRO; MDR clinical evidence for medical devices.
Clinical research in Türkiye, on site and end to end
Medex started in 2013 as a site management organisation: research coordinators and study nurses placed in hospitals across Türkiye. In 2022 we built a full-service CRO on top of that network, and with Medisol CTS we take study visits to the patient’s home. Three units, one evidence chain.
For sponsors this means one counterpart from feasibility to close-out: the people who recruit and follow the patient work in the same group as the people who plan the study, submit it to the authority and monitor the data.
Who does what
Each unit has its own site; all three work as one group.
Medex SMO
Site management since 2013. Our coordinators and research nurses work inside hospitals, so sites recruit faster and keep their data clean.
- Site coordinators and research nurses
- Patient recruitment and retention
- Equipment rental and calibration
- Investigator payment operations
Medex CRO
Full-service clinical research since 2022: from protocol and submissions to monitoring, data and the final report, across Phase I–IV and medical devices.
- Regulatory affairs and ethics in Türkiye
- Clinical operations and monitoring
- Data management and biostatistics
- Medical device clinical evidence (EU MDR)
Medisol CTS
Clinical trial support services from Ankara for decentralised and patient-centric studies: the visit goes to the patient, not the other way round.
- Home-based study visits and cold chain
- Patient transfer with a zero-delay protocol
- 24/7 patient-centric support
- Equipment, thermal monitoring and calibration
CRO services across the study lifecycle
Thirteen services, run by one team in Türkiye. Open any item for the scope.
1Clinical operations in Türkiye
Phase I–IV execution with risk-based planning and milestone tracking.
- Site performance oversight
- Budget control
- Proactive escalation
2Protocol development and medical writing
- Protocols and amendments
- Informed consent forms
- Investigator brochures
- Clinical study reports
- Regulatory submission documents
3Regulatory affairs in Türkiye
- Dossier preparation and submission
- Communication with the authority (TİTCK)
- Response management
- Ongoing compliance
4Ethics committee and regulatory authorisation
- Ethics committee and IRB applications
- Query management
- Timeline tracking
5Clinical trial agreements and contracts
CTA negotiation and contract management between sponsor and sites.
6Site feasibility and study start-up
- Site capability assessment
- Enrollment validation
- Essential documents and contracts
- Site readiness
7Study monitoring and quality oversight
- On-site and remote monitoring
- Source data verification
- Issue tracking and CAPA
8Pharmacovigilance and safety management
- Adverse event reporting
- SAE reconciliation
- Safety communication and timelines
9Data management and clinical data oversight
- Validation and cleaning
- Database oversight
- Vendor alignment and reconciliation
10Biostatistics and analytical strategy
- Design input and sample size
- Statistical analysis plan
- Interim and final analysis
- Interpretation
11Vendor and laboratory management
Selection, contracting and oversight of central labs and specialised vendors.
12Study close-out and reporting
- Final documentation
- Close-out visits and notifications
- Clinical study report
- Archiving
13Medical device clinical research
Clinical investigations, clinical evaluation under EU MDR, PMCF, post-market surveillance, usability and performance studies, device submissions.
For medical device and implant manufacturers
Clinical evidence under the EU Medical Device Regulation, generated where the product is actually used.
Clinical evaluation (CER)
Data review, gap analysis, literature search and the clinical evaluation report your notified body expects.
PMCF and post-market surveillance
Post-market clinical follow-up studies and surveillance plans that keep the CE mark alive after launch.
Usability and performance studies
Evidence on how clinicians actually use the device, from formative work to summative studies.
Device submissions
Regulatory and ethics submissions for device studies in Türkiye.
Data from the clinic
With AIDA, dental clinics record implant reference and lot, follow-up visits and research consent. Consented data leaves pseudonymised and encrypted and feeds the PMCF file.
See how the loop worksSite services by Medex SMO
Hospital-based work, run by people who are physically at the site.
1Site operations management
- Protocol feasibility
- Staff training and certification
- SOP development
- Data management and quality control at site
2Patient recruitment and retention
- Targeted recruitment
- Screening and enrolment optimisation
- Retention programmes
- Patient education
3Site regulatory compliance
- Ethics committee applications
- Site regulatory document management
- Audit readiness
- GCP compliance
4Study start-up and close-out
- Site selection
- Contract and budget negotiation
- Investigator meeting coordination
- Close-out and archiving
5Equipment rental and calibration
- Flexible rental periods
- Maintenance and accredited calibration
- Certificates and reminder schedule
- Installation support
6Investigator and HCP payment operations
Speaker and consultancy contracts, consent forms, receipts, invoice collection and signature visits, handled as one traceable process for pharmaceutical companies.
7RECIST assessment and imaging consultancy
- RECIST 1.1, RANO and Lugano
- Independent oncology image review
- Imaging charter
- Training and QC audits
Therapeutic areas and study types
Therapeutic areas
- Oncology
- Hematology
- Cardiovascular
- Endocrinology and metabolic
- Neuroscience
- Pulmonary
- Immunology and inflammatory
- Dermatology
- Rare diseases
Study types
- Phase I and early phase
- Late phase (II–IV)
- Medical device clinical investigations
- Post-marketing surveillance
- Real-world data and evidence
- Observational and epidemiological
- Bioequivalence
- Biosimilar
Starting a study in Türkiye
Three approvals run largely in parallel. The timelines below are the typical ranges from our sponsor guide.
- 1
Ethics committee
Application to the responsible ethics committee; typically four to eight weeks to opinion.
- 2
Regulatory authority (TİTCK)
Submission to the Turkish Medicines and Medical Devices Agency; typically four to eight weeks.
- 3
Site activation
Contracts, essential documents and site initiation; typically two to four weeks once approvals are in.
Ranges are indicative and depend on study type and completeness of the dossier.
Quality and training
ISO 9001 quality management
Both the SMO and the CRO run a risk-based quality management system aligned with Turkish regulation and GCP.
GCP training approved by TİTCK
Medex delivers Good Clinical Practice training approved by the Turkish authority, most recently at Başakşehir Çam and Sakura City Hospital.
Published evidence
Data monitoring by Medex supported the TURKAPNE cohort of 12,715 patients across 34 centres, published in the Journal of Clinical Sleep Medicine in 2026.
Planning a study in Türkiye?
Send us the synopsis. We answer with a feasibility view, not a brochure.