Inspection readiness & GCP trainings

QualityCR is a consultancy agency that offers support with risk- and quality management in clinical trials.

We assist universities, hospitals and governmental organizations with GCP inspection readiness and with tailor-made GCP trainings.

We do this by conducting thoroughly audits and by offering several kinds of GCP trainings, data integrity and quality management in clinical research. 

Your staff is working hard to acquire the best productivity possible while also being compliant. An imminent inspection approaches and you want to make sure that you fully followed the right procedures and have in posession all the documentation needed, filled in, signed and dated accordngly; all of this in the shortest period of time possible.

And what about the risks that were taken during the clinical trial performance? Have they been throughly assessed according to the current regulations?

Inspection readiness & audits

The objectives of GCP audits are to ensure that the rights of trial subjects are respected, the data is reliable and that the integrity of the trial data can be assured. Routine self-inspections and audits of clinical trials can be scheduled during any phase of development and at any time during the conduct of the trial. According to your needs, after a GAP analysis we can either conduct general audits, or detailed audits on a specific topic (such as protocol, data privacy, data integrity, et cetera).

We have established the following methodology:

  • Start-up meeting: discussion with the client on the scope of the audit/self-inspection
  • Development of an audit/self-inspection plan and audit agenda
  • Conducting the audit/self-inspection
  • Documentation of all relevant findings and recommendations in a report
  • Close-up meeting: presentation of the findings and recommendations
  • Evaluate the new situation at regular intervals (upon request)
Photo about the subject GCP audit readiness

Can we help you prepare for an inspection or audit?

Would you like us to audit a trial site for you?

Contact us

Training you and your team

Our courses are intended for professionals who perform biomedical research, including clinical trials, with people, human material or with patient data according to the standards required by the national and international authorities. The aim of our trainings is to increase the knowledge on methods to improve the integrity and the quality of clinical research. Quality management of clinical research will be discussed by introducing the legal requirements of Good Clinical Practice (GCP).

Our trainings can be customized according to your needs; we can either focus on general aspects of good clinical practice or we can go into detail and address only specific topics.

Training topics

  • Good Clinical Practice (GCP)
  • Preventing scientific misconduct and fraud during biomedical research
  • Legal and ethical aspects of drug testing
  • Data integrity
  • General principles of quality management applied to clinical research
  • Quality assurance and quality control in clinical trials
Photo about our GCP trainings we can organize

Are you interested in one of our trainings?

Contact us