Completed and ongoing projects
>10 000

Subjects for the last 3 years

Annual revenue increase

FTEs annual growth
Non-clinical research
The process of creating a drug is long, and their study begins with non-clinical studies. It is non-clinical studies of drugs that are the basis for further clinical trials.

ACCELLENA offers services for the development of a non-clinical (preclinical) research program for new drugs, and also organizes such research on the basis of one of the largest research centers in Europe, which combines a nursery, a world-class vivarium and modern laboratories.
Human pharmacology
Early phases studies overview
Since 2017 ACCELLENA has been organizing and conducting human pharmacology studies, including first phase studies (including first-in-human studies) and bioequivalence studies.

The company has the capacity and expertise to conduct early research into small molecules and biological products through its own Human Pharmacology Research Center (Phase I Unit).

ACCELLENA is participating in single and multiple dose escalation cohort studies, studies with “3+3” design and others.

The team has considerable experience in conducting pharmacokinetic and pharmacodynamic studies, including bioequivalence studies.

The company has studied the comparative pharmacokinetics of various dosage forms, including sprays, and also has experience in studies with pharmacodynamic end points.

latest update 05/JUL/22
Early phases expertise
To date, the company has conducted 15 phase I trials and 6 phase I/II trials of small molecules, biologics and medical devices. Alltogether, more than 1800 subjects were included in these early studies.

Back in 2019, a Middle East Respiratory Syndrome (MERS) vaccine study was launched, laying the foundation for the success of two first-in-human clinical trials in 2020 of one of the world’s first Sputnik V vaccines against novel coronavirus infection (SARS-CoV-2) in very difficult conditions of the anti-epidemic measures.

Since 2015, the company has participated in 28 clinical bioequivalence (BE) studies, including studies with replicative design, pharmacodynamic endpoints, fasting or fed conditions. In total, more than 1,000 participants took part in these studies.

Early phases cases
A representative selection of relevant cases
Clinical trials
Late phases studies overview
Since 2015, we have been organising and conducting scientific and clinical trials of drugs, implementing new methods of diagnosis and treatment in accordance with international ethical and regulatory requirements.

Being at the forefront of science, we ensure fast release and availability of the most modern medicines and means of preventing socially significant diseases.

To date, we have carried out more than 70 clinical trials in various therapeutic areas in Eastern Europe and Asia. More than 3600 subjects were included in the 15 completed late phases studies.

One of our major business lines is vaccine trials. To date we've conducted a dozen of large-scale studies of vaccines against influenza, MERS, tuberculosis, SARS and others with thousands of subjects.

latest update 05/JUL/22
Late phases expertise
Accellena's first clinical trial in 2015 was a proof-of-concept trial of an antitumor drug conducted in the USA, Europe and the CIS. By 2018, the company conducted more than 15 clinical trials, and by mid-2022, we took part in more than 70 clinical trial projects.

More than 25 of these were late phase clinical trials at various stages, including 15 completed by today.

The company has acquired the greatest experience in late phase research in the following areas: research on vaccines, infectious diseases, oncology, neurology, gastroenterology and surgery.

The company's experience is not limited to clinical trials. Since 2015, Accellena has been involved in major case-control epidemiological studies in the field of infectious diseases. We has successfully conducted a study of medical nutrition, cellular biomedical products (CAR-T therapy), and are actively involved in the study of the safety and efficacy of medical devices, both diagnostic and used for treatment, including life-threatening conditions in CPR units.
Late phases cases
A representative selection of relevant cases
Data Science
Data Management
Data management (DM) services are being provided by Accellena 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 60 clinical trials of various phases and types, in which data from more than 10,000 study subjects were processed.

latest update 05/JUL/22
Reflex IWRS.
ACCELLENA uses its own Interactive Web Response System (IWRS) called "Reflex".

The system allows to distribute subjects and form groups using various randomization methods, distribute research products by centers and subjects, take into account and register visits of research participants to research centers.

Reflex system is relatively new, but has already been used by us in more than 10 different projects, showing functionality and ease of use.
LINZA is a set of algorithms designed for extensive analysis of data obtained in the course of clinical trials, as well as their practical use in the management of clinical trials in order to identify previously unexplored patterns, deviations from "standard" observed phenomena and assess risks.

LINZA is a centralized statistical monitoring product and a source of assessment data for use in risk based monitoring.

The system saves resources, especially in situations where instant scaling up is impossible, for example, in dynamic and large clinical trials, when the timely collection and analysis of verified data is the most crucial process in time management of the project.
Real World Data (RWD) / Real World Evidence (RWE)
Real World Data (RWD)/Real World Evidence (RWE)
From the very beginning, since 2015, ACCELLENA has been conducting research using the RWD to obtain evidence of the effectiveness and safety of certain types of therapeutic interventions in real clinical practice.

Although organizing these types of trials is not easy, the volume and value of collected real-world data play a significant role in the development of a medicinal product, both before its registration and during its lifespan.

Currently, leading regulators are developing and improving the regulatory framework for such studies, and we use the most modern technologies and mechanisms that allow us to trust the data and results of such studies without a doubt. These include data collection and processing systems, a centralized statistical monitoring system, and various approaches to risk assessment and mitigation. All this allows, using effective and convenient tools, to obtain reliable data (RWD), conduct timely and relevant research, and form an evidence base based on real clinical practice.

latest update 30/AUG/23
RWD/RWE expertise
To date, the company has conducted three 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
A representative selection of relevant cases
“If we would serve science, we must extend her limits, not only as far as our own knowledge is concerned, but in the estimation of others.”

— Rudolf Virchow
ACCELLENA headquarters:

Tel.: +7 (812) 337 58 66
Fax: +7 (812) 337 58 08

88, lit.A., Sredniy pr. V.O.,
St. Petersburg, Russia,

Kesklinna linnaosa, Vesivärava
tn 50-201, Estonia, Tallinn,
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