Biomapas offers a tailored-service approach, taking into account the individual needs of our partners and the unique characteristics of each study. Biomapas 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 clinical monitoring team receives on-going 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 Manager (CTM) coordination;
- Support during site audits and inspections.
For any inquiry regarding our services, please contact Biomapas Business Development team.