Clinical trials audit
Clinical trials audit
You are a biotech/ pharmaceutical company, a contract research organization,
or a vendor. You want to organize and conduct an audit, and you need
independent external resources? We can help you!
We will help to improve the existing program of auditing, make it productive
and based on real risks
We can conduct and investigational site audit
We can audit a vendor (for example, a CRO, IMP warehouse, investigational
laboratory etc.)
We can audit the Trial Master File
Expertise
We can conduct any type of GxP audit in any place in Eurasia
200+ audits
Our team has performed about 200 GxP audits in EU, CIS, and Africa
No borders
We are fluent in 4 languages
Our team
Key experts in clinical trials conduct, quality
assurance, quality control, and auditing,
members of the British Association of
Research Quality Assurance (RQA)
Maxim Bunimovich
Independent GCP consultant
QA consultant, trainer (TMQA), with significant experience in audits and inspections of investigational sites in
different countries worldwide, as well as practical experience in the construction of quality management systems for CROs and sites
Dmitriy Manuilov
R&D Head
R&D Head in Maxwell, a Russian company, with significant experience in product development, studies conduction, auditing, construction of quality assurance systems.
Maria Leer
Manager
Clinical research quality assurance manager in one the largest global pharmaceutical
companies
Clients relay on us
Book a service
Send us a message if you plan an audit or want to book consulting service


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