Certifications & Corporate Recognition

We run end-to-end clinical research operations to international standards and document quality and data integrity at every step.

Quality Framework

Standards We Follow

The badges below are not certificates we hold; they show the standards and frameworks our operations are governed by. Documented certificates join this page as documents are supplied.

ISO 9001 — Quality Management ISO 9001
ISO/IEC 27001 — Information Security ISO/IEC 27001
ISO/IEC 17025 — Testing & Calibration ISO/IEC 17025
GMP — Good Manufacturing Practice GMP
ICH-GCP — Good Clinical Practice ICH-GCP
GCLP — Good Clinical Lab Practice GCLP
GLP — Good Laboratory Practice GLP
FDA 21 CFR Part 11 — Electronic Records FDA 21 CFR Part 11
CAP — College of American Pathologists CAP
ISBER — Biological Repositories ISBER
KVKK — Personal Data Protection KVKK
ALCOA+ — Data Integrity ALCOA+
SPICE — Software Process Cert. SPICE
USBS — Sağlık Bakanlığı Onaylı USBS
Corporate Recognition

A Proven Track Record

1997

Türkiye’s First CRO

29 years of uninterrupted clinical research experience since our founding — we pioneered the industry’s establishment in Türkiye.

Top 500

Top 500 Service Exporters

We are listed among Türkiye Exporters Assembly’s (TİM) Top 500 Service Exporters — global proof of our cross-border clinical research volume.

3,500+

Peer-Reviewed Publications

Omega-authored peer-reviewed publications in international journals including The Lancet — a scientific contribution verifiable through the PubMed index.

SAKDER

Member of the Contract Research Organizations Association

We are listed among the members of SAKDER, the association representing Türkiye’s CRO sector (founded 2009).

www.sakder.org.tr ↗

Our Quality Assurance Systems

Learn about our quality management systems, audit and inspection readiness, SOP development and CAPA processes.

Go to Quality Assurance