Inspection readiness & GCP trainings
QualityCR B.V. is your go-to consultancy for comprehensive support in risk and quality management across clinical trials and pharmaceutical production.
We assist universities, hospitals, sponsors and third parties in achieving GCP and GMP inspection readiness through audits. Our expertise extends to audits, inspection readiness, QMS optimizatio, and day-to-day QA and compliance activities.
Furthermore, we also have experience in GMP and GDP authorisation update.
As your team strives for peak productivity, the looming inspection demands a meticulous review of procedures and documentation. Ensuring everything is correctly performed and documented is our priority to expedite the process.
But it doesn't stop there. We understand the risks inherent in clinical trial performance. Have they been rigorously assessed according to current regulations? Let us navigate this crucial phase together, ensuring not only compliance but also a robust understanding of potential risks.
Your success is our mission, and we're here to streamline your journey to excellence.
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)
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
Are you interested in one of our trainings?
Contact us