CTIS Portal Management
Clinical Safety
The Clinical Trials Information System (CTIS) is the centralized European Union portal for submitting and managing clinical trial applications, ensuring streamlined regulatory interactions and transparency across member states.
PVpharm offers specialized CTIS Portal Management services to support sponsors with clinical trial submissions and lifecycle management under EU CTR 536/2014.
Our services include:
- Clinical trials application support: Preparation and submission of clinical trial applications via CTIS in compliance with EU regulations
- Documents management: Ongoing management of trial documents, notifications, and safety reports within the portal
- Clinical trial coordination: with Regulatory Authorities and Ethics Committees across EU member states
- CTIS requests: Monitoring and responding to queries or requests through CTIS
- CTIS qualification: Training and support for internal teams on CTIS processes and best practices
