Clinical Monitoring

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.

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