Process compliance and quality assurance for clinical trials

Process compliance and quality assurance

We provide consulting in the field of clinical research and development in all aspects of compliance management and the optimization of GCP processes. In addition to various audits, we offer consulting and support in the development or adaptation/optimization of quality management systems for CROs, sponsors and various service providers. Workshops with process analyses for the improvement of process flows and for inspection preparation round off our service.

Quality and integrity of data along defined processes

In the field of clinical research on medicinal products, the safety of the study participants and the quality and integrity of the data must be safeguarded through appropriate processes, which in turn must be assessed for compliance. Large financial investments are at stake, especially in research programmes in the pharmaceutical industry. Thus, quality management for clinical trials is required in many aspects: on the one hand, regulatory compliant and efficient processes have to be established, the responsible persons / service providers have to be trained or qualified and compliance with the requirements has to be reviewed regularly so that the sponsor or the trial centre can pass regulator inspections. As part of our process-oriented quality management approach, QFINITY∞ offers support for various aspects of GCP compliance.

When providing our services, QFINITY∞ not only brings with it sound process expertise, but also profound IT knowledge, so that we are able to reflect and evaluate the associated IT systems right from the start when considering the processes. Thus, with every QFINITY∞ audit, considerable cost efficiencies result from the inclusion of IT aspects in every audit, thereby elimination the need for separate IT audits. At the same time, the aspect of data integrity in such audits is properly considered in all its facets through this interdisciplinary approach.

Our service in the area of Good Clinical Practice (GCP) Compliance:

  • Vendor/Supplier Qualification Audits (Second-party audits), e.g. before and after contracting of CROs, laboratories, software service providers.
  • GCP audits at clinical trial sites
  • GCLP audits at clinical laboratories
  • Mock audits as preparation for inspection
  • First-party audits as an internal quality assurance measure
  • Workshops for process analysis in the service of continuous improvement / efficiency enhancement