Clinical Operations Quality Assurance Support

Ensuring Compliance, Data Integrity, and Clinical Trial Participant Safety in Clinical Trials

Clinical trials demand precision, compliance, and transparency. Regulatory agencies worldwide enforce strict Good Clinical Practice (GCP) standards to protect clinical trial participant and ensure reliable study outcomes. However, maintaining compliance isn’t just about passing inspections—it’s about building a strong quality foundation that minimizes risk, enhances efficiency, and ensures data integrity.

At Biomapas we offer a proactive quality assurance strategy and provide risk-proportionate quality assurance services tailored to the specific needs of your trial. Whether supporting Sponsors, CROs, or clinical sites, we ensure GCP compliance through comprehensive audit programs, inspection readiness strategies, and proactive risk management.

We provide a full spectrum of Clinical Operations Quality Assurance services. Depending on your project needs, the GCP audits can be offered as stand-alone services or integrated into a broader quality assurance solution.

Audits & Compliance Assessments

• Clinical Investigator Site Audits – Evaluating compliance at trial sites across all phases (I-IV, bioequivalence, post-marketing) and ensuring readiness for regulatory inspections.
• Clinical Study Document Audits – Reviewing trial documentation for accuracy, completeness, and regulatory adherence.
• GCP System Audits – Assessing internal processes, SOPs, and training programs to strengthen GCP compliance.
• Clinical Safety Audits – Verifying the integrity of safety data and patient protection measures.
• GCP Vendor Audits – Evaluating CROs, laboratories, data management, IMP storage and distribution and other vendors to ensure quality and compliance.

Inspection Readiness & Training

• Inspection Readiness Support – Mock inspections, gap analysis, processes review and staff training for upcoming regulatory reviews.
• GCP Training for Investigators – Certified ICH GCP training programs meeting TransCelerate BioPharma standards.
• Quality Management & Risk-Proportionate Programs
• Tailored QMS Development & Maintenance – Establishing and maintaining Quality Management Systems (QMS) for consistent compliance.
• Risk-Proportionate Quality Assurance Programs – Identifying and mitigating risks proactively to enhance trial efficiency.
• Biomapas is certified by the Lithuanian State Medicines Control Agency – to provide investigator training in compliance with ICH GCP standards.

Partner With Biomapas

With a proven track record in clinical trial quality assurance, Biomapas provides tailored, expert-driven solutions that ensure your trial meets the highest regulatory standards. Whether you need a one-time audit or ongoing quality support, we’re here to help.