DE

Quality Assurance in Clinical Trials

We compare quality with the patient's safeguard

FGK has a Quality Management System that is second to none. We are compliant with GCP-ICH guidelines, applicable local regulatory requirements and standard operating procedures, and we take particular pride in the high-quality structure that we have developed and the quality culture we live.

Nonetheless, we continue to dedicate considerable efforts to testing and improving internal processes and believe in continuous process improvement despite passing multiple satisfactory inspections from regulatory authorities.

Stringent quality control measures go hand in hand with the FGK’s philosophy of delivering sound results but, above all, they safeguard the patients or healthy volunteers in your clinical trial. Tangentially, it also protects you as a study sponsor.

Apart from the in-house quality supervision, our QA department performs study site, process and systems audit.

  • Gautier Sobczak, My-Data-TRUST

    Co-Founder & Chief Business Officer

    “FGK is a long-standing and trusted Partner who identified early on the critical importance of data privacy in clinical research. We've been working together for many years, combining their strong clinical expertise with MDT's data privacy know-how to support Sponsors in enhancing efficiency, ensuring compliance, and building trust in the data collected. The trust developed over time enables fast, high-quality results on both sides, and we look forward to continuing this successful partnership journey!”

What we do in the Quality Assurance department

  • We adhere to GCP and ICH guidelines, standard operating procedures and other regulatory requirements
  • We carry out investigator site audits, database audits, systems audits, vendor evaluations
  • We also audit ourselves to prove the compliance with the norms and internal quality system
  • We continuously improve our processes through corrective and preventative actions
  • We implement appropriate modifications to the quality system and standard operating procedures