We manage complex administrative and operational burdens on your behalf—streamlining and accelerating the entire process.
Ethics Committee and Competent Authority Submissions
We prepare and submit complete application packages, manage all official correspondence and handle all revision/question cycles.
We define requirements based on study type (pre-market or post-market), target country and regulatory pathway; manage Ethics Committee and Competent Authority submissions; resolve deficiencies and follow the process until approval.
Our goal: fast approvals, minimal administrative workload and full regulatory compliance.
Comprehensive Project Management
Our experienced project managers coordinate:
• Site identification & feasibility
• Investigator training & initiation visits
• Contract & budget management
• Timeline oversight
• Logistics & investigational product management
• Risk management & ongoing communication
Monitoring & Site Management
Our CRA team ensures:
• ISO 14155 / ISO 20916 / GCP compliance
• Full protocol adherence
• Data accuracy and integrity
• Effective management of safety events
Our goal: smooth site operations, uninterrupted study progress and flawless data quality.