BiotechCRO
Clinical trials, access programs and consulting in Turkiye.
BiotechCRO supports sponsors, biotech companies and research centers with clinical trial feasibility, site selection, study start-up, monitoring, ethics and regulatory coordination, Early Access and Named Patient Program operations.
Clinical Operations
Local research execution with access-program expertise.
BiotechCRO brings together clinical research discipline and Turkiye-specific healthcare access knowledge. The platform is designed for sponsors that need one local partner across study planning, center coordination, monitoring and access-program follow-up.- Feasibility, site selection, investigator mapping and enrollment planning
- Ministry of Health, ethics committee, TITCK and documentation coordination
- Early Access, Named Patient and Post-Trial Access program operations
Capabilities
Focused CRO support for studies that need speed, discipline and local clarity.
01
Feasibility and Site Selection
Indication, patient potential, site experience, investigator profile, competition and enrollment risk are assessed before commitment.02
Regulatory and Ethics Readiness
Submission planning, document packages, ethics committee workflow, TITCK communication and local compliance support.03
Monitoring and Quality
Source data verification, GCP alignment, protocol deviation follow-up, site visit planning and corrective action tracking.04
Project Management
Timelines, vendors, study centers, communication rhythm, escalation points and sponsor reporting are coordinated locally.05
Data and Archive
Data entry support, clinical research archive coordination, documentation tracking and close-out readiness.06
Access Program Operations
Humanitarian access, EAP, NPP and Post-Trial Access workflows are managed with the same clinical-quality discipline.Sponsor Ready