Quality Assurance

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.

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.

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

We are Participant of an independent “GCP Qualification Program”

Conducting GCP audits usually requires a lot of preparation and resources by a client. FGK is the first CRO that joined the “GCP Qualification Program”, which was set up by Rephine Ltd., UK in 2017. By choice, any client who would like to evaluate FGK’s company procedures or to qualify FGK for their outsourcing purposes has the option to save time and costs required for an extensive audit by purchasing all-encompassing audit information directly from Rephine. The audit report written by an experienced independent auditor gives an accurate overview of our operations and GCP compliance status.