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)

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

The company has established itself as a stable and reliable business partner that fulfills its obligations with high quality and in a timely manner

Ruzanova E.A.

Head of the Development Department
Federal State Unitary Enterprise St. Petersburg Research Institute of Vaccines and Serums of the Federal Medical-Biological Agency of Russia

Launch your study

Please share some details of your upcoming study

Through evidence
to the stars

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

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

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