THE QARP is an international team of coaching trainers, experts, and auditors in clinical trials
OF EXPERIENCE in the international clinical trials market (since 2016)
completed Russian and English trainings and workshops in clinical trial area
audits in various GxP areas worldwide
pre-inspection audits and FDA, EMA and Federal Service for Surveillance in Healthcare (Roszdravnadzor) inspections hosting
Our goals |
The QARP goal is to develop an interactive platform for an open discussion regarding clinical trials and quality management aspects for Russia and foreign experts. We perform trainings, workshops, and develop new educational techniques
We have teamed up to improve educational principles and paradigms for experts
Performance of training workshops on conduct, organisation and quality of clinical trials
Performance of all types of GxP audits, assistance in development of Quality Management System, etc.
Our employees are high-class specialists with a vast experience in international and local clinical trials
Consulting in development and maintenance of Quality Management System
Independent international GCP auditor
Maxim Bunimovich is an International GCP auditor, QA consultant, trainer with a considerable experience in audits and inspections of study sites in various countries worldwide (EU, CIS, Africa), as well as practical experience in development of quality management systems for CRO and sites (over 10 years of experience).
Expert, independent auditor and trainer in Good Clinical Practice, The QARP
Alena Kulikova is a clinical trial expert who has a vast knowledge and practical experience in organisation, coordination, monitoring, quality verification, and audit of clinical trials, as well as training of all involved parties. She has significant experience in organisation and performance of trainings at the international level for hundreds of CT specialists throughout Europe and the Middle East.
The QARP Expert in Good Clinical Laboratory Practice
Polina Gremyakova is highly proficient in performance of laboratory audits, development and generation of quality management systems of laboratories performing analyses in clinical trials (GCLP). She is experienced in laboratory certification for conformity with GLP and ISO 9001:2015 requirements.
Head of the quality assurance and control at the Medical Department of R-Pharm JSC
Anastasia Aleksandrova is an expert in quality management of clinical and preclinical studies, and pharmacovigilance. She is also a member of the British Research Quality Association (RQA) and an active participant of local and international conferences on quality assurance.
Quality assurance manager in biotechnological company argenX
Ekaterina Rybkina is a quality management expert, the leading auditor (BSI Lead Auditor), GCP auditor with an over 10-year work experience in clinical trials. She is a member of the British Research Quality Association (RQA), quality auditor certified by the American Society of Quality (ASQ CQA).
Training and quality assurance manager at the Medical Department of R-Pharm JSC
Kristina Vlasova is an expert in quality assurance of preclinical and clinical trials with a 9-year work experience in pharmaceutical industry. She is also a member of the British Research Quality Association (RQA).
You can write to us with any questions or cooperation offers you might have