10 years at the forefront
of clinical research
and pharmaceutical Development

10 years
at the forefront
of clinical research
and pharmaceutical
Development

About us

Since 2015, Accellena R&D has been a reliable partner for pharmaceutical companies in conducting a full cycle of research: from preclinical studies to large-scale international clinical trials and the implementation of innovative treatment methods.
 
Our main asset is a team of 60+ highly qualified experts, whose average experience in the field of clinical research exceeds 8 years. It is their expertise that has allowed us to successfully execute more than 130 studies across 27 therapeutic areas from oncology to cardiology, ensuring impeccable compliance with international standards in Eastern Europe and Asia.
 
Your confidence in tomorrow begins with our solutions today.

Late phases studies overview

Since 2015, we have been organizing and conducting scientific, preclinical, and clinical studies of medicinal products and medical devices.
 
To date, we have successfully conducted over 53 late-phase clinical studies across 27 therapeutic areas.
 
One of the key directions of our work is clinical vaccine trials. Our experience includes conducting large-scale studies of vaccines against COVID-19, pneumococcal and meningococcal infections, influenza, Middle East Respiratory Syndrome (MERS), tuberculosis, SARS, and other diseases with the participation of thousands of volunteers. Our specially designed Vaccine Fast Track approach utilizes advanced algorithms and data-driven forecasting to accelerate studies without compromising quality.
Early phases studies overview
Since 2015, our company has specialized in organizing and conducting early-phase clinical studies, including:

  • Phase I studies, including first-in-human (FIH);
  • Bioequivalence (BE) studies;
  • Early studies of small molecules and biologicals.
 
Our key capabilities:
  • Conducting cohort studies with single and multiple ascending doses;
  • Experience working with various study designs, including the "3+3" design;
  • Deep expertise in pharmacokinetics (PK) and pharmacodynamics (PD).
 
Over the years of work, Accellena R&D has studied the comparative pharmacokinetics of various dosage forms, including sprays, and has experience in studies with pharmacodynamic endpoints.

Data Management and Biostatistics

Our team ensures impeccable data management in more than 110 projects involving over 26,000 participants — from Bioequivalence (BE) studies and phases I-IV to RWE/RWD studies. We build databases that meet regulatory requirements through meticulous CRF design, medical coding, and adverse event (AE) or serious adverse event (SAE) reconciliation, strictly adhering to GCDMP standards and tight deadlines.

Deep expertise in biostatistics begins at the study design stage: we strategically select primary endpoints and optimize methodology to control costs, ensure sufficient study power, and anticipate regulatory challenges. We use validated software and ensure seamless interaction between the statistician and programmer, which guarantees audit-ready analysis and preserves data integrity. A wide range of professional software is used for data analysis, including SAS, SPSS, WinNonlin, and R, allowing us to select the most suitable tool for the tasks of each project.

Real World Data (RWD) / Real World Evidence (RWE)

Since its founding in 2015, Accellena R&D has been conducting studies using real-world clinical practice data to generate evidence on the effectiveness and safety of therapeutic interventions in real-world clinical settings (Real-World Evidence, RWE).
 
We specialize in conducting studies based on real-world clinical practice data (Real-World Data, RWD). Our infrastructure includes:
 
  • Advanced data collection and processing systems that ensure data integrity and accuracy.
  • Centralized statistical monitoring for ongoing quality control and risk minimization.
  • Proactive risk management approaches that allow for the identification and mitigation of potential threats at early stages.
 
This integrated approach enables us to effectively transform RWD into a reliable RWE evidence base, providing our clients and partners with a competitive advantage in product market entry and positioning.
    Our devotion to evidence-based medicine is fostered by our daring dream of healthy humanity expanding to space.
    Inception
    Feb
    2005
    Team formation during our multinational clinical trial in Eastern Europe. This collaborative project enabled specialists to connect and build strong working relationships for future cooperation.
    Foundation
    Apr
    2015
    Establishment of Accellena R&D and initiation of our first international clinical trial for an orphan oncology drug in the U.S. and Europe.
    Exploration
    Sep
    2018
    Implementation of new capabilities and services, including in-house data management and biostatistics, which paved the way for the company's numerous successful clinical trials.
    Evolution
    Jul
    2025
    Accellena R&D has conducted over 130 clinical and preclinical trials across 27 therapeutic areas in all phases, involving more than 26,000 participants. The company employs over 60 professionals.
    ACCELLENA milestones
    ACCELLENA milestones
    Inception
    Feb
    2005
    The core of the team has gathered and started to conduct international clinical trials for world's top pharmaceutical companies in Eastern Europe.
    Foundation
    Apr
    2015
    ACCELLENA company has been established and started its first international clinical trial for anti-cancer orphan drug in the USA and Europe.
    Exploration
    Sep
    2018
    Implementation of functions including in-house data science services had paved path to numerous successful clinical trials like in-hospital antibiotic resistance clinical study with around 1000 enrolled subjects.
    Evolution
    Jan
    2025
    ACCELLENA conducted more than 120 various clinical trials of all phases (including large phase III study, first-in-human vaccination study and early pharmacology trial) with 22000+ enrolled subjects up to now.
    We are the people of Accellena
    Through evidence
    to the stars
    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

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