outpatient
hospitals
Using a deep understanding of different health systems, medical documentation, and excellent auditing methodology, we effectively identify non-compliances and performance deficiencies.
In addition to GCP focused observations, we provide, on request, process improvement suggestions for the clinical sites.
Based on multiple site audits, sponsor's might benefit from a CRO performance assessment that might be additionally analysed and separately reported.
Phase 1 Units require a unique approach and experience during GCP audits. Regulatory requirements are rather minimal across most countries, and a mutual Sponsor-Phase 1 Unit agreement on the quality standards serves as the basics for effective audit.
We provide:
Qualification Audits of phase 1 units / Clinical Pharmacology Units
Phase 1 clinical trials operational Audits
Advice on the quality standards required for early phases
Additionally to comprehensive GCP rules, our audits follow the principle of the MHRA Phase 1 Accreditation scheme and refer to them.
We audit laboratories according to our own SOPs following the requirements of:
EMA; Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (2005)
RQA; Good Clinical Laboratory Practice-GCLP (2012)
The auditing procedures are compliant with the ISO 15189 - "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples."
Essential documents for clinical trials Audit
TMF (Trial Master File) audits to evaluate the conduct of a trial and the quality of the data produced
Remote audits of electronic TMF
Regular TMF audit for ongoing trials
Pre-inspection TMF audit
Pre-submission TMF audit
Among others following system audits are available
QMS System
Safety in Clinical Trials
IT
Archiving
Monitoring and project management
CRO qualification audit, during the contractual phase of clinical trial
CRO performance audit during the clinical trials, includes vendor and project management as well as the effectiveness of the monitoring
According to ICH GCP E6 5.2.2 (addendum), all sponsors with clinical trials outsourced to CRO should confirm the appropriate level of oversight. Sponsor Oversight Audit focus on the effectiveness of operational and quality measures implemented to carry out oversight. It might be performed at any trial stage.
Qualification of vendors is a prerequisite for a project and should take place before the contract.
The vendor audit assesses the vendor's quality system before the contract or periodically QMS and the vendor's performance during the contract. Management can check if the operational team follows all the oversight requirements. The scope of such an audit might also cover project management.
Do you need any of such, GCP, audits?