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Alexander Kansky,
GCP auditor, monitor, project manager,
certified member of ACRP and RQA
with unique experience, qualification and professional approach.

ABOUT ME

Hello.

I am Alexander Kansky, GCP auditor and expert in international clinical trials, certified member of ACRP and RQA with unique experience, qualification and professional approach.

I have been working within the international clinical trial industry per ICH GCP standard since 2004, including 15 years with major contract research organizations (IQVIA, PSI, Parexel, Covance). My career path also included more than 5 years of direct work for headquarters of leading international pharma and biotech companies.

Since 2018, I am conducting investigator site audits per ICH GCP standard. In total, I have conducted more than 50 investigator site audits in Russia, Ukraine, Bulgaria, Georgia, Serbia, and Turkey. My versatile experience includes GCP project management, CRA team leading, clinical trial liaison, central monitoring and regulatory affairs.

Recommendations from customers and colleagues are available on Linkedin and on request.

You can also get acquainted with the materials of the mass media.

SERVICES

Advantages

What makes me stand out?

Diplomacy

A unique and very efficient style of negotiations

Productivity

Staying productive and maintaining critical thinking in the environment of conflicts of interest, shortage of time and resources

Documentation culture

Reporting and written communications per the highest industry standards

Risk analysis

Deeply thought out application of risk-oriented approach

Network

Broad professional network (investigators, project managers, auditors, monitors, vendors)

International experience

Recommendations from industry senior managers

My experience and expertise

I have been working within the international clinical trial industry per ICH GCP standard since 2004.

I have directly maintained or supervised contact with regulatory authorities in Russia, Belarus, Georgia or Slovakia (including clinical study applications, responding to queries, safety reporting, study progress reporting).

I have monitored more than 30 clinical studies across all clinical development phases in the following therapeutic areas: allregology, cardiology, dermatology, endocrinology, gastroenterology, gynecology, hematology, hepatology, infectious diseases (including COVID-19 vaccine and diagnostic test), oncology, orphan diseases, pediatrics, psychiatry, pulmonology (respiratory medicine), surgery, urology.

My experience includes small start-up and site selection projects as well as long-term phase III studies up to 5 years in duration (COPD, hypertension) from the study set-up to termination. I have experience with managing a device study in Russia.

FULL PORTFOLIO

Since 2014, I have worked as a clinical project lead or a project manager in international clinical studies by U.S., German, Austrian and Italian sponsors.

In 2020 – 2022, I have worked as a central monitor, directly reporting to headquarters of a leading U.S. biotech company.

I have conducted more than 50 investigator site audits in Russia, Ukraine, Bulgaria, Georgia, Serbia, and Turkey and two remote investigator site audits in Japan and South Korea.

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