Clinical Monitoring & Site Management
Biomapas clinical monitoring and site management offers a tailored-service approach, taking into account the individual needs of our partners and the unique characteristics of each study. Our Clinical Research Associates (CRAs) are dedicated to an average of 3 protocols at a time, empowering them to focus on excellence and quality assurance, understanding the intricate issues of the protocol and/or indication (disease), as well as ensuring site compliance.
Our team receives ongoing training, to ensure they are completely up to date with current legislation, techniques and technologies.
Clinical monitoring services include, whilst not limited to:
- Country feasibility studies and site identification and assessment;
- Ethics committee and regulatory authority submissions;
- Translation of study-specific documents including quality check;
- Assistance in obtaining local insurance;
- Training of investigators and their teams (e.g. GCP, safety reporting, IMP handling, protocol, etc.);
- Clinical trial oversight in order to assure compliance with the protocol and applicable regulatory requirements;
- Accurate source verification for reliable clinical data;
- Site support on prompt recruitment process;
- File compilation, review and maintenance;
- Investigational Medicinal Product (IMP) and Clinical Trial Materials (CTM) coordination;
- Support during site audits and inspections.