Clinical Trial Auditing
We provide auditing services to sponsors and CROs. Our certified lead auditor performs a wide range of audits for clinical trials activities that include:
- Investigator Site audit (e.g., routine, for cause, pre-inspection)
- Phase 1 Unit audit
- Service Provider audit – qualification, routine or follow-up audit – (e.g., CRO, vendors, Core Lab)
- Critical Document audit (e.g., Protocol, Patient Information Notice and Consent Form, Clinical Study Report, Investigator Brochure)
- Study Trial Master File audit (TMF / eTMF)
- System / Process audit (e.g., auditing processes across several clinical trials)
- On-site, remote or hybrid audit
- internal and second-party audit
- Regulation (EU) No 536/214, Regulation (EU) 2017/745, Regulation (EU) 2016/679 (know as GDPR), national regulatory requirements…
- Good Clinical Practice (GCP) Auditing
- Good Clinical Laboratory Practice (GCLP) Auditing
- ISO 19011:2018, ISO 14155:2020, ISO 13845:2016, ISO 9001:2015 and more
- Audits in France, Europe and more
We timely provide detailed audit report to management with activities performed and a comprehensive description of observations. Our audit reports undergo a review by a senior auditor before submitting to the end-client.
In addition, we support sponsors address the audit’s observations with effective CAPA management.
CQI IRCA Certified Lead Auditor
20+ years of experience in clinical research
Clinical Quality Management System
From a detailed gap analysis to implementation of a new regulation we support sponsors to develop or optimize their clinical quality system to align with their organizational goals and applicable regulations.
We provide consultancy services for Clinical Quality Management System development and compliance.
- Our Gap analysis report include a detailed description of observations and recommendations
- Process mapping, Development or improvement of SOPs and work instructions for clinical operations
- Validation and Compliance of eClinical systems, including Interactive Response Technology (IRT), Clinical Trial Management Systems (CTMS), electronic Case Report Forms (eCRF), electronic Trial Master Files (eTMF), electronic Clinical Outcome Assessments (eCOA), and electronic Patient Reported Outcomes (ePRO).
Our consultant has experience developing and optimizing clinical quality systems that comply with various regulatory frameworks, including
- EMEA & FDA/CRF regulations : Regulation (EU) No 536/214, Regulation (EU) 2017/745, 21 CFR 820….
- GCP: ICH E6 Good Clinical Practice, ISO 14155:2020
- GCLP guidelines
- ISO 13485:2016 and more
Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction, and skillful execution; it represents the wise choice of many alternatives.
— William A. Foster
Subject Matter Expert Support
Enhance your quality team with our experienced consultant for specific project or task for a short- or long-term engagements.
- Good Clinical Practice Inspection Preparation (e.g., Training for Site Staff, Storyboards, eTMF readiness)
- Quality risk management : risk identification, analysis, communication, control; escalation as required
- Risk Based Auditing Planing
- Deviation management
- CAPA management
- GxP Suppliers management (supplier identification; qualification; approval; annual compliance status evaluation; quality audit planning; conduct quality audit/report, CAPA approval/closure)
- Support during health Authority Inspection
- QMS implementation/maintenance/oversight
- Change control management
We assist sponsors in interpreting and adapting to shifting EU regulatory frameworks while streamlining clinical operations to boost overall efficiency and compliance.
Talk to Our Expert
Zoé Moksi
Clinical Operations Consultant & GCP Auditor