Who CliniGA CRO supports
CliniGA connects clinical operations, regulatory strategy, sites, data and medical device evidence across Türkiye and international markets.
- Pharmaceutical, biotechnology and health technology organizations: Phase I–IV, observational, real-world and digital evidence programmes.
- Medical device manufacturers: EU MDR clinical evidence, investigations and post-market clinical follow-up.
- Hospitals, research centers and investigator networks: protocol operations, site coordination and study conduct support.
Clinical research organization services
Sponsors can engage CliniGA CRO for a focused work package or an integrated delivery model covering feasibility, start-up, conduct and close-out.
- Clinical operations and monitoring: feasibility, study start-up, site selection, on-site and centralised monitoring, and project management under ICH-GCP.
- SMO and site coordinator support: site identification, coordinator resourcing and site-level quality oversight in Türkiye, scaled per study after feasibility.
- Regulatory affairs: submission dossiers, ethics and authority planning, amendments and lifecycle maintenance for Türkiye and European programmes.
- Medical device clinical evidence: EU MDR 2017/745 clinical evaluation planning, ISO 14155-aligned investigations, PMCF strategy and technical documentation input.
- Quality systems and compliance: risk-based quality management, SOP frameworks, deviation and CAPA handling, audit and inspection readiness.
- Data, biostatistics and medical writing: data management, statistical planning, clinical study reporting and publication support with documented human review.
- Site network and feasibility: protocol-led site selection, evidence-based recruitment assumptions and operational readiness assessment across qualified sites and partners.
- Clinical technology and sample integrity: cold-chain monitoring, chain of custody, equipment lifecycle control and operations reporting, qualified and piloted per project.
Evidence-led delivery
CliniGA states assumptions rather than promises, applies quality-by-design and proportionate oversight, and requires human review before a deliverable reaches a sponsor.
- Scope, responsibilities, decisions and escalation routes are documented before work starts.
- Sites, timelines and recruitment assumptions are tested during feasibility before they enter a plan.
- Privacy and security are designed around GDPR and KVKK principles.
- Türkiye, Europe including Central and Eastern Europe, and the Middle East are supported subject to country-specific feasibility and contracting.