Clinical and Medical Affairs
Good Clinical Practice (GCP).
Consistently implementing GCP in accordance with ICH E6(R2) in practice. We support pharmaceutical and medtech companies with GCP training, compliance assessments, and thorough audit preparation to ensure that your clinical trials meet the highest quality standards.
What GCP challenges arise in clinical trials?
ICH E6(R2) GCP is the gold standard for clinical trials—but there are often problems with its implementation:
- GCP requirements are not fully understood or implemented by newly appointed trial sites or CROs.
- Informed consent, source data verification (SDV), and the trial master file (TMF) are common areas of concern during inspections.
- GCP training standards within the study team are inconsistent, which poses significant compliance risks.
- Despite ongoing studies, overall audit and inspection readiness is not consistently ensured.
Can you provide clear evidence that every single member of your study team is up to date on GCP training?
Our GCP services.
We’ll help you establish GCP not as a rigid bureaucratic requirement, but as a highly effective quality tool.
GCP Training & Certification
In-house GCP training for study teams, investigators, and medical staff at clinical research sites. We offer basic and refresher training courses that strictly adhere to ICH E6(R2), including the issuance of official certificates and legally compliant documentation of training completion.
GCP Compliance Assessment
Systematic and independent assessment of the GCP status of ongoing clinical trials: Trial Master File (TMF) review, protocol deviation analysis, consent documentation, and vendor oversight. Identification of blind spots and risks, accompanied by clear recommendations for action.
GCP Audit (Sponsor & Site)
Professional sponsor audits of internal GCP quality management systems, as well as on-site audits of selected trial sites. We prepare comprehensive audit reports in accordance with the ICH E6 standard, including prioritized CAPA recommendations for immediate corrective action.
GCP Inspection Preparation
Thorough preparation for upcoming regulatory GCP inspections (EMA, BfArM, PEI, FDA): GCP review, realistic mock inspections, and targeted coaching for staff on inspection-related questions.
Frequently Asked Questions About Good Clinical Practice.
What does ICH E6 GCP cover?
The ICH E6 Guideline (Good Clinical Practice) defines international ethical and scientific quality standards for the design, conduct, recording, and analysis of clinical trials. Its primary objective is to protect trial participants and ensure the full credibility of the trial data for subsequent marketing authorization applications.
Who exactly is required to be GCP-trained?
Essentially, all individuals directly involved in a clinical trial: principal investigators, study coordinators, clinical research associates (CRAs), project managers, data managers, and relevant members of the internal quality assurance team. This training must be refreshed at regular intervals and fully documented.
What is the key difference between ICH E6 R1 and R2?
ICH E6(R2) updates the original version (R1) to reflect technological advances in clinical trials. Among other things, it introduces risk-adaptive monitoring, calls for significantly stronger quality management system approaches, and defines more explicit rules for "sponsor oversight" when contracting with a CRO. It has been the legally applicable standard since 2016.
What does "informed consent" mean, and what GCP guidelines apply in this context?
Informed consent is the documented and entirely voluntary agreement given by a study participant prior to their enrollment in the study. According to GCP, the following are mandatory: a complete verbal explanation, written documentation, consent prior to any study-specific procedure, and regular renewal in the event of significant protocol changes.
Additional expertise in GCP and clinical trials.
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