At ACRS, we understand the critical importance of quality in every aspect of the clinical trial we do. Our commitment to excellence is reflected in our comprehensive in house Quality Management System (QMS), which forms the foundation of our operations and ensures that our sponsors receive the highest standard of service.

According to ICH-GCP E6 (E2), quality assurance is defined as “all planned and systematic actions established to ensure that testing is performed and data is generated, recorded and reported in accordance with Good Clinical Practice (GCP) and applicable regulatory requirements”. In ACRS, we have a team of QA & QC with multiple skills, working in multiple strategic methods, tools in QMS, Delivering knowledge with impressive outcomes in awarded clinical trials.

This versatile and experienced team of QA & QC provides a full range of services including but not limited to:

• Assisting sponsors with preparations for audits and regulatory inspections (e.g. DCGI, U.S. FDA, EMA, as well as from other national authorities).
• Broad range of audit types including but not limited to:
  • On-site audits
  • Trial Master File audits
  • Monitoring project audits
  • Process audits
  • Vendor audits
  • Pharmacovigilance audits
  • Country Medical Department audits
  • Internal audits