Home 9 Clinical Research 9 Quality & Compliance

Quality & Compliance

Biomapas Quality and Compliance Assurance activities help our clients to ensure the integrity of their clinical trials and protect research subjects’ rights and welfare.

In addition to our internal Quality Assurance activities, we provide external individual quality audits as well as a full Quality Assurance and Compliance program on a project-specific basis. Our thorough assessment and objective recommendations help our clients and sites to implement the most effective actions to correct and prevent issues. Audits are conducted with a professional attitude giving the auditee a good educational opportunity and added value to the client.

Our Quality Assurance team has the knowledge and experience required for executing Pharmacovigilance Systems audits to Marketing Authorization Holder’s, their commercial partners, distributors, subsidiaries and CROs ensuring compliance to GVP modules and applicable local regulation. Since 2007 Biomapas provides ICH-GCP investigator training, which program is approved by Lithuanian State Medicines Control Agency. Our ICH-GCP training meets the Minimum Criteria for ICH E6 GCP Investigator Site Personnel Training identified by TransCelerate BioPharma.

Quality Assurance Activities:

  • Quality Management System implementation, standard operation procedures (SOPs) development, risk management, and regulatory compliance;
  • Compliance with EN ISO 9001:2015 certification requirements;
  • Auditing: planning, conduct and reporting;
  • CAPA plans development, root cause analysis and follow-up;
  • Training and quality consultancy;
  • Inspection readiness support;
  • Hosting audits and regulatory inspections.

We conduct the following types of audits:

 

  • Investigator site audits (Phase I-III clinical trials, post-marketing activities, routine, for-cause and pre-inspection audits);
  • Other GCP audits (Trial Master File audits, monitoring process and project management audits, study start-up audits, data management audits, clinical trial document audits, etc.);
  • Early phase facilities audits;
  • Medical device audits;
  • GVP audits;
  • GcLP audits;
  • Vendor audits, including GDP depot audits;
  • Regulatory Affairs audits.