MARTIAL VERSCHOOT

Services

In-House GCP auditing clinical trials

CRO Qualification and Re-qualification

Auditing clinical trials systems and processes

Project Management audits

Implementation corrective and preventive actions

process improvements

Trial Master File audits

Facilitation of Regulatory Inspections

Presence in front or backup room :

Preparatory training for Regulatory Inspection(s)

Handling and tracking of documentation requests

Preparing staff in advance of interviews

Support in responding to Regulatory Inspection report(s)

Implementation and follow-up of Inspection responses subsequent to the Regulatory Inspection

Conducting GCP Investigator Site Audits

In-House and On-Site Auditing

Implementation corrective and preventive actions – process improvements

Clinical Quality Assurance Training

Basic and refresher GCP training

Consulting on GCP questions

Regulatory Inspection preparation training (GCP)