Quality and Compliance

Biomapas quality and compliance assurance services help our clients to ensure the integrity of their clinical trials. In addition to providing in-house quality assurance auditing for clinical trial sites, CROs and third party vendors, we help our clients to protect research subjects’ rights and welfare, verify the integrity of data and ensure adherence to protocols and international regulatory guidelines. We provide quality assurance audit service as part of a full-service or a stand-alone project. Our thorough assessment and objective recommendations help our clients and sites to develop the most effective actions to correct and prevent issues.

Biomapas is a ICH GCP investigator training provider, certified by the Lithuanian State Medicine Agency. Our GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial Sponsors.

Our Quality and Compliance services include:

  • Clinical investigator site audits (Phase I/Bioequivalence facilities and clinical trials, Phase II-III clinical trials, post-marketing activities, routine, for-cause and pre-inspection audits to help sites prepare for regulatory agency reviews);
  • Clinical study document audits and reviews;
  • Clinical investigator site compliance visits;
  • GCP and GVP quality system audits, in which we assess client internal processes, standard operating procedures (SOPs), staff training programs, as well as provide recommendations for improvement;
  • Safety surveillance/pharmacovigilance audits;
  • Vendor audits, assessments and qualifications, including GDP depot audits, in which we evaluate a client’s vendors to ensure they have sufficient capacity and capability to deliver quality based services on time and in compliance with regulations.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

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