© Sole Proprietor Alexander Kansky,
OGRNIP 314784721000200, registered on July 29, 2014
Project Management
and CRA team leading.
SERVICES
I provide a wide range of corporate diplomacy services in the field of clinical research.
I work as a private consultant. If needed for your projects, I can set up a team of well-trained and qualified contractors
(a virtual contract research organization).
GCP Audits
Investigator site, CRO, vendor audit. Inspection readiness assessment.
Monitoring
On-site, remote and central monitoring. Proactive identification and mitigation of risks in clinical trials.
Evaluation of monitors
Co-monitoring visits and assessment of CRA competencies.
Mentoring and Training
of CRAs and site teams.
Consultations
on local legislation and clinical trial market in Russia and Eurasian Union (Belarus, Kazakhstan, Armenia).
Regulatory Affairs
Regulatory Authority communication and supporting activities (Russia, Belarus, Kazakhstan, Armenia).
Feasibility Assessment
Fast and efficient country/site study feasibility assessment. Site selection visits.
Study Start-Up
Preparation and submission of a dossier for approval of a study by the Ministry of Health, preparation of clinical trial contracts, obtaining export and import licenses, consulting on logistics, vendors, etc.
Patient Recruitment
Consultations on optimizing recruitment of patients and volunteers in clinical studies.
SOP
Writing standard operating procedures and working instructions for the clinical research department, drawing up forms and documentation templates.
Documentation Development
Writing a monitoring plan, laboratory guidelines, information sheets for patients and healthy volunteers, advertising and informational materials for patients and volunteers.
Documentation Management
Work with ETMF (preparation of a TMF plan, collection, verification, analysis of clinical trial documents, identification and correction of inconsistencies).
Vendor Management
and consultation on vendor selection.
ABOUT ME
Alexander Kansky
GCP auditor, monitor, project manager, certified member of ACRP and RQA with unique experience, qualification and professional approach.