Are you a biotech/pharmaceutical company, a contract research organization, or a medical institution? Do you want to book and organize a training on clinical trials aspects for your employees? We can develop corporate training and conduct it at your site or remotely.
We can adapt the program to your audience.
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Our courses are constructed in a manner that allows course material to be consumed in an engaging and interactive ways. Gamification, a proven educational method, is the founding principle of our courses
The training materials are based on the most frequent mistakes in real practice. We use audits and inspection results to create relevant case studies for the course participants
Each instructor assigned to the course has considerable experience in the industry as well as in teaching the subject. Making the courses captivating and informative is the guiding principle of our team
We have performed more than 200 practical training in the following areas:
Management of discrepancies during the monitoring
Basic and advanced GCP compliance
Data management and statistics
GLP and GCLP compliance
Quality Management System development and implementation
Key experts in clinical trials conduct, quality assurance, quality control, and auditing, members of the British Association of Research Quality Assurance (RQA)
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.
Dr. Hanna PreuS, MRQA
Director, 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, RQA
Experienced Quality Assurance (QA) auditor since 2007 with experience in GLP/GCP CRO organisations working to both UK/EU and international regulatory requirements.
Is an experienced Quality Assurance professional covering both GCP and CSV
Sabrina 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.