ACCELLENA
Research & Development
2022
Research & Development
2022
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Late phases studies overview
Since 2015 we have been organizing and conducting scientific, preclinical, and clinical studies of pharmaceuticals and medical devices, as well as implementing new diagnostic and treatment methods in compliance with international ethical and regulatory standards.
To date, we have conducted over 130 clinical trials across 27 therapeutic areas in Eastern Europe and Asia, spanning all phases.
One of our key focus areas is vaccine clinical trials. Our experience includes large-scale studies of vaccines for COVID-19, pneumococcal and meningococcal infections, influenza, MERS, tuberculosis, SARS, and other diseases, involving thousands of volunteers. Our specially developed Vaccine Fast Track approach utilizes advanced algorithms and data-driven forecasting to accelerate research without compromising quality.
To date, we have conducted over 130 clinical trials across 27 therapeutic areas in Eastern Europe and Asia, spanning all phases.
One of our key focus areas is vaccine clinical trials. Our experience includes large-scale studies of vaccines for COVID-19, pneumococcal and meningococcal infections, influenza, MERS, tuberculosis, SARS, and other diseases, involving thousands of volunteers. Our specially developed Vaccine Fast Track approach utilizes advanced algorithms and data-driven forecasting to accelerate research without compromising quality.
Early phases studies overview
Since 2015, our company has specialized in organizing and conducting early-phase clinical trials, including:
- Phase I studies, including first-in-human (FIH) trials;
- Bioequivalence (BE) studies;
- Early-phase studies of small molecules and biologics.
- Conducting cohort studies with single and multiple ascending doses;
- Experience with various study designs, including the "3+3" dose-escalation scheme;
- Deep expertise in pharmacokinetics (PK) and pharmacodynamics (PD).
Data Management and Biostatistics
Data management (DM) services are being provided by Accellena R&D from 2015. From 2017 we have it as in-house department.
We provide services for database and EDC development, data collection and routine data management, as well as data processing in accordance with Good Clinical Data Management Practice.
Since 2017 we have collected and processed data for more than 120 clinical trials of various phases and types, in which data from more than 22,000 study subjects were processed.
We provide services for database and EDC development, data collection and routine data management, as well as data processing in accordance with Good Clinical Data Management Practice.
Since 2017 we have collected and processed data for more than 120 clinical trials of various phases and types, in which data from more than 22,000 study subjects were processed.
Real World Data (RWD) / Real World Evidence (RWE)
Since its establishment in 2015, Accellena R&D has been conducting real-world evidence (RWE) studies to evaluate the effectiveness and safety of various therapeutic interventions in real-world clinical settings.
Today, leading regulatory agencies are actively developing and refining guidelines for such studies. At Accellena R&D, we employ cutting-edge technologies and methodologies to ensure the reliability and credibility of our research data, including:
These solutions enable us to:
By combining regulatory expertise with innovative tools, we help bridge the gap between clinical research and everyday patient care.
Today, leading regulatory agencies are actively developing and refining guidelines for such studies. At Accellena R&D, we employ cutting-edge technologies and methodologies to ensure the reliability and credibility of our research data, including:
- Advanced data collection and processing systems:
- Centralized statistical monitoring:
- Comprehensive risk assessment and mitigation approaches.
These solutions enable us to:
- Generate high-quality real-world data (RWD) efficiently
- Conduct timely and relevant clinical studies
- Build a robust evidence base grounded in real-world clinical practice (RWE)
By combining regulatory expertise with innovative tools, we help bridge the gap between clinical research and everyday patient care.
Our devotion to evidence-based medicine is fostered by our daring dream of healthy humanity expanding to space.
Inception
Feb
2005
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
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
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
2025
Accellena R&D has conducted over 130 clinical and preclinical trials across 27 therapeutic areas in all phases, involving more than 36,000 participants. The company employs over 70 professionals.
ACCELLENA milestones
ACCELLENA milestones
Inception
Feb
2005
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
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
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
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
Kayaking Tour 2025
- Konstantin ZakharovFounder of Accellena R&d"We are passionate about creating and implementing new time and cost-effective tools and methodologies, such as comparative PK/PD studies that take a wider range of factors altering metabolism into consideration, or applying new managerial methodologies in the way we organize our research teams".
- Artem SergeenkoProject Management"The key is integral thinking, in which each team member is aware of their unique function and area of responsibility, and at the same time, is able to perceive the health of the project in its entirety. We are strong in people and teams, this is the secret of successfully passing critical milestones of a trial and faster drug development. Isn't this what humanity needs?"
- Maria BelavinaQUALITY ASSURANCE"Quality assurance is not a matter of trust anymore, it is rather a technological challenge that is being solved today with the use of superior IT tools tailored individually for each project in compliance with GCP. And last but not the least, her majesty "discipline" - the holy grail of evidence-based medicine - rules everything."
- Alexandra EllerData Management"In clinical research, data management (DM) is a powerhouse, driving the accuracy and success of studies. By embracing advanced and efficient DM techniques, researchers can streamline data collection, analysis, and standardisation, especially critical in multicenter and international studies. This proactive approach not only speeds up the drug approval process but significantly boosts the odds of research success."
ACCELLENA headquarters:
Tel.: +7 (812) 337 58 66
Fax: +7 (812) 337 58 08
info@accellena.com
88, lit.A., Sredniy pr. V.O.,
St. Petersburg, Russia,
199106
Kesklinna linnaosa, Vesivärava
tn 50-201, Estonia, Tallinn,
10152
Tel.: +7 (812) 337 58 66
Fax: +7 (812) 337 58 08
info@accellena.com
88, lit.A., Sredniy pr. V.O.,
St. Petersburg, Russia,
199106
Kesklinna linnaosa, Vesivärava
tn 50-201, Estonia, Tallinn,
10152
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