From a brilliant idea to regulatory approval: a full cycle of clinical trial management

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Full-Service CRO

Transforming a scientific idea into a registered drug. End-to-end.

Planning and Design

Building the foundation for a successful study

Development of the drug’s clinical strategy
Study design development
Project feasibility assessment
Development of a complete submission package for the Ministry of Health
Selection and evaluation of investigational sites
Final report development
Scientific and literature reviews

Regulatory Affairs

Expert support at all stages of regulatory interaction

Preparation of submission packages for the Ministry of Health
Execution of regulatory submissions
Preparation of responses to Regulatory Authorities' queries
Modules CTD 2, 4, 5

Biometrics

Full data lifecycle management for precise results

CRF development
Design and programming of the clinical database (CDB)
Medical and pharmaceutical coding
Routine data management
Sample size calculation and justification
SAS and R code development
Development of the statistical section of the protocol
Development of the Statistical Analysis Plan (SAP)
And much more

Project Management

Complete control and execution at all stages

Project management
Clinical monitoring
Site management
Medical monitoring
Safety and pharmacovigilance
Vendor management
Logistics and warehouse

Clients Testimonials

Prof. Raul Gainetdinov

Professor, Head of Laboratory of Neuroscience and Molecular Pharmacology at St. Petersburg State University

"In ACCELLENA, we have found a reliable partner for the development of new pharmacologically active substances discovered in our laboratories. Over nearly three years of joint work, we have nearly completed the preclinical development stage and are approaching the initiation of first-in-human studies."
Dr. Viktoria Dedkova

Deputy head of the Scientific research center “Eco-Safety”

"Throughout our years of collaboration with ACCELLENA, we have participated in dozens of joint clinical research projects. Prompt issue resolution, professionalism, and dedication are the defining qualities of our colleagues at ACCELLENA."
Mrs. Marina Zakharova

Executive secretary at the Independent Ethics Committee “BioEthics”

"Our ethics committee has been supporting clinical trials conducted by ACCELLENA for over five years. The consistent quality of submitted documentation, coupled with effective communication in resolving emerging issues, contributes significantly to the quality and ethical standards of the company's research."

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Through evidence
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Tel.: +7 (812) 337 58 66
Fax: +7 (812) 337 58 08
info@accellena.com

ACCELLENA headquarter:
88, lit.A., Sredniy pr. V.O.,
St. Petersburg, Russia,
199106