Audit

If you are a biotechnological, pharmaceutical company, contract research organisation, study site, or laboratory willing to organize and perform
an internal audit or an external evaluation of your subcontractor, and you need outsourcing for that, then we definitely are your best choice!

Our experts have performed over 500 audits in EU, EAEU, CIS,
and Latin America countries.

Clinical trial audit
We will help you improve the existing programme
of internal audits and make it more efficient with regards to present risks.
We will perform an in-person audit in EAEU, EU, CIS countries of:
A clinical study site
Sponsor and/or Investigator File
Preclinical study site
Contract Research Organisation
Pharmaceutical warehouse
Logistics company
Local and analytical laboratories
Data management processes
Medical writing, etc.
Clinical trial remote audit
Modern technologies have paved the way for some types of remote audit.
The QARP project is ready to help you and to perform online audits worldwide of, for example:
Trial Master File
Contract Research Organisation
Logistics company
Local and analytical laboratories
Medical writing, etc.
When prepared correctly, the format of audit performance can optimise expenses and time necessary for an audit which is especially relevant under
the pandemic conditions.

Preparation for an inspection

The QARP experts have a unique experience of participation in inspections by Russian and foreign regulatory authorities (10 MoH inspections,
5 FDA inspections, 6 EMA inspections, 5 СНАС inspections).

We are ready to help you with preparation of
a study site/organisation for an inspection with regards to the requirements of national and foreign regulators, as well as, to support methodically document flow during
the inspection period.
Our team
Maxim Bunimovich
Independent international GCP auditor

Maxim Bunimovich is an International GCP auditor, QA consultant, trainer (Tower Mains) 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 Kulikova
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.
Polina Gremyakova
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.
Form for an audit application
You can write to us with any questions or cooperation
offers you might have
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