About the company
The QARP is an international team of coaching trainers, experts, and auditors in Clinical Trials
7 YEARS
Of experience in the international clinical trials market (since 2015)
1400 +
completed Russian and English trainings and workshops in Clinical
Trial area
Trial area
900 +
audits in various GxP areas worldwide (including site quality control visit)
16
pre-inspection audits and FDA, EMA and Federal Service for Surveillance
in Healthcare (Roszdravnadzor) inspections hosting
in Healthcare (Roszdravnadzor) inspections hosting
Announcements
Our goals
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The QARP goal is to develop an interactive platform for an open discussion regarding Clinical Trials and quality management aspects for experts. We perform trainings, workshops, and develop new educational techniques
We have teamed up to improve educational principles and paradigms for experts
Our competencies
How can we be helpful?
Trainings
Organizing and conducting interactive trainings and seminars
(remote and face-to-face, open and corporate)
(remote and face-to-face, open and corporate)
GxP Compliance
Organisation and performance of GxP audits, inspection readiness and follow-up from any inspection or audit in accordance ICH-GxP guidelines
Consulting
Consulting in development and maintenance of Quality Management System and Regulatory Affairs
Our team
- Maxim BunimovichIndependent international GCP auditorMaxim 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). - Alena KulikovaExpert, independent auditor and trainer in Good Clinical Practice, The QARPAlena 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. - Polina GremyakovaThe QARP Expert in Good Clinical Laboratory PracticePolina 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.
- Dr. Hanna PreuS, MRQADirector, Clinical Quality Assurance (Global Process and Continuous Improvement Lead), Astellas Pharma
- Global Quality & Compliance Expert, Auditor and Business Strategist
- Quality Culture & Quality Management System
- Operational Excellence, Process Compliance and Agile Project Management
- Clinical Operations and Quality Strategy
- Business Integration and Process Improvement
- Broad experience in regulatory and GxP standards
- Paul MacMahon, RQAExperienced Quality Assurance (QA)
auditor since 2007 with experience in
GLP/GCP CRO organisations working
to both UK/EU and international regulatory
requirements. - Sabrina DeyIs an experienced Quality Assurance professional covering both GCP and CSVSabrina Dey is an experienced Quality Assurance professional, being highly proficient both in GCP and CSV. She has significant experience in the management of numerous QA activities including but not limited to: the conduct of GxP audits, training, and SOPs oversight and management.
They trust us
Contact us
THE QARP
info@theqarp.com
Ul. Adama Branickiego 21 U3
Warsaw; Mazowieckie;
Postal Code: 02-972
Warsaw; Mazowieckie;
Postal Code: 02-972