MARTIAL VERSCHOOT
Our team
Martial Verschoot
Key Responsibilities
In-House auditing clinical trials
Conducting Investigator Site Audits
Facilitation of Regulatory Inspections
(presence in front or backup room)
GCP Quality Assurance Training
Experience
13 years experience End Stage Renal Disease (Head Male nurse Kliniek Zwarte Zusters).
Subsequent to University, 28 years’ QA experience in all therapeutic area’s (Bristol-Myers Squibb and Quintiles (IQVIA), mainly GCP (conducted amongst other 450+ Investigator Site Audits - ISA’s in most EU countries, Latin America and USA).
Executive Director within Quintiles (IQVIA’s) multinational QA Department (managed up to 30+ QA and 25+ Clinical Operations staff members).
Lead and participated in EMA and FDA inspections in Europe; in-house, on-site and Customer inspections, in total 40+ inspections, (majority Investigator site inspections, in- house and on-site), e.g.Belgium, France, Greece, Germany, Poland, Romania, Russia, The Netherlands, Switzerland, Ukraine; In addition, conducted two in-house audits in Japan, and on-site audits in Latin-America and USA). Lead two in-house Regulatory Inspections, (UK and US office inspection on Customer’s behalf).
During previous years teaching assignments as member of the faculty at:
- Rotterdam Hogeschool, The Netherlands; ESAME Foundation, Spain; University Limoge, France, BARQA (RQA), Masterclass, Cranfield University, UK; University of Antwerp, Belgium
- During career, delivered QA presentations to BfArM, Italian, Romanian, Egyptian Regulators
- Lead Auditor (Quintiles) at the EMA/FDA inspection(s) related to the Inspection Harmonization Initiative (presented conclusions at the Drug Information Association (DIA) meeting, Genève, Switzerland in presence of participating inspectors).
Dr. Denys Syebov, MD
Key Responsibilities
Clinical Quality Assurance services
GCP Consultancy
GCP, GDP, GVP Vendor, CSR, MDD, Investigator site, Process & Protocol audits
Inspection Readiness
GCP Regulatory Inspections preparation and follow-up
Experience
Medical Doctor specialized in internal medicine and oncology, graduated from Odessa State Medical University in 1999.
Over 25 years of extensive experience in clinical trials spanning clinical operations, medical affairs, and quality assurance across various therapeutic areas at pharma and contract research organizations.
Independent GxP Consultant (mainly GCP, GDP, GVP) with a proven track records of conducting around 300 on-site and remote audits across USA, Europe and APAC countries.
People Leader, having managed a multinational Quality Assurance department of staff members across USA, EU and APAC regions.
Lead and Co-Facilitator of 115 GCP regulatory inspections (FDA, EMA, MHRA, PMDA, other country / region local Health Authorities) in Europe and APAC (in-house, on-site, remote).
Accomplished presenter at numerous Clinical Research Associates (CRAs) and Investigator Meetings, representing Clinical Quality Assurance.