品質保証・コンプライアンス
品質保証・コンプライアンスは、すべての試験活動が規制基準と倫理ガイドラインを満たすことを保証する、当社オペレーションに不可欠な要素です。
サブサービス
Quality Management Systems
Developing and implementing comprehensive QMS to standardize processes and enhance quality.
Audits and Inspections
Conducting regular audits and preparing for regulatory inspections to ensure GCP compliance.
SOP Development
Creating and maintaining comprehensive SOPs that guide clinical trial activities.
CAPA Processes
Implementing Corrective and Preventive Actions to identify and resolve quality issues.
Related Service
FDA · EMA · TİTCK Inspection Readiness
Meet the inspection expectations of all three regulators in one package: mock inspections, Part 11 EDC verification, CTIS serious breach reporting and the TİTCK Trust Practices package.
Related Guide
The Türkiye Clinical Trial Regulatory Hub: TİTCK & KAP
The parallel TİTCK–ethics approval, the KAP/KAM pathway, required documents, approval timelines and SUSAR reporting — an English-language guide.