Uncompromising Ethical Standards
We operate under the highest ethical principles, as outlined in the Declaration of Helsinki and ICH-GCP guidelines. Our team is dedicated to protecting patient rights and confidentiality in every interaction and data point, ensuring that all study activities are conducted with integrity and respect.
Proactive Regulatory Strategy and Submission
Our experts possess deep knowledge of local and international regulatory landscapes, including EMA, FDA, and TİTCK. We don't just react to regulations; we anticipate them. We develop proactive submission strategies, prepare complete and rigorous dossiers, and manage all agency communications to secure timely approvals and maintain compliance throughout the study lifecycle.
Comprehensive Ethics Committee Navigation
We expertly manage the entire ethics committee submission and approval process. From identifying the appropriate committees to preparing and submitting tailored documentation, we ensure a smooth and efficient pathway to approval, addressing potential ethical questions before they arise.
Rigorous Quality Management & Monitoring
Our robust Quality Management System (QMS) includes standardized procedures, rigorous training, and proactive risk-based monitoring. We continuously oversee all study activities to ensure strict adherence to the protocol, SOPs, and regulatory requirements, guaranteeing data integrity and patient safety at every stage.
Data Privacy and Security Excellence
In an era of global data transfer, we are experts in implementing stringent data protection measures compliant with international and local regulations, including the GDPR (General Data Protection Regulation) and Turkey's Law on the Protection of Personal Data (KVKK). We ensure that all patient data is collected, processed, and stored with the highest level of security and confidentiality, providing a seamless and compliant framework for studies operating in or involving data from Turkey and the EU.