"In ACCELLENA, we have found a reliable partner in the development of new pharmacologically active substances discovered in our laboratories. In almost three years of joint development, we have almost completed the preclinical development stage and are close to the first in human study initiation."

Prof. Raul Gainetdinov

Professor, Head of Laboratory of Neuroscience and Molecular Pharmacology at St. Petersburg State University
"Over the years of cooperation with ACCELLENA, we have participated in dozens of joint clinical research projects. Prompt resolution of issues, professionalism and involvement are the main features of our colleagues from ACCELLENA."
Dr. Viktoria Dedkova
Deputy head of Scientific research center “Eco-Safety”
"Our ethics committee has been providing support for clinical trials conducted by ACCELLENA for more than five years. Consistent quality of the documents provided, effective communication in solving emerging issues - all this contributes to the quality and ethics of the research conducted by the company."
Mrs. Marina Zakharova
Executive secretary at Independent Ethics Committee “BioEthics”
Early phases expertise
To date, the company has conducted 21 Phase I trials and 8 Phase I/II trials of small molecules and biological products. A total of more than 1,800 subjects were enrolled in these early-phase studies.

Back in 2019, we initiated a Middle East Respiratory Syndrome (MERS) vaccine study, which established the foundation for successfully conducting two first-in-human clinical trials in 2020 of "Sputnik V" - one of the world's first COVID-19 (SARS-CoV-2) vaccines - under extremely challenging epidemiological conditions.

Since 2015, the company has participated in 60 bioequivalence (BE) studies, including replicate design studies, pharmacodynamic endpoint studies, and fasted/fed conditions studies. In total, more than 2,000 participants were enrolled in these studies.


Early phases cases
Late phases expertise
The first clinical trial conducted by the company in 2015 was a proof-of-concept study of an anticancer drug, carried out in the USA, Europe and CIS countries. By 2018, Accellena R&D had already conducted more than 12 late-phase clinical trials, and by mid-2025, the company participated in over 47 Phase II and III clinical studies.

Among late-phase trials, we have gained the most extensive experience in vaccine studies, infectious diseases, oncology, neurology, gastroenterology and rheumatology.

We have also repeatedly participated in large epidemiological studies (such as case-control methodology) in the field of infectious diseases.

Additionally, we have successful experience in:
  • Medical nutrition research;
  • Development and testing of cell therapies (including CAR-T);
  • Safety and efficacy evaluation of medical devices - both diagnostic and therapeutic, including those for emergency care in CPR units.
We help bring medical innovations to life - from scientific concept to real-world application.

Late phases cases
RWD/RWE expertise
To date, the company has conducted 4 research projects using real clinical practice data.

The first of these was the study of the use of hormone therapy in the treatment of breast cancer. Despite the relatively small number of participants, much attention was paid to the duration of follow-up of health status, as well as the qualitative assessment of response to treatment according to RECIST.

The other two projects were large case-control epidemiological studies to study the preventive efficacy of an antiviral agent and an influenza vaccine in large (several thousand people) production teams.

Within the framework of these projects, issues related to the comprehensive collection of data on incidence in the entire study population were successfully resolved.
RWD/RWE cases
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
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