ACCELLENA
Research & Development
2022
Research & Development
2022
ACCELLENA
Clinical and non-clinical research
Clinical and non-clinical research
ACCELLENA
clinical and non-clinical research
ACCELLENA
clinical and non-clinical research
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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
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
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
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
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
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
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
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
Our devotion to evidence-based medicine is fostered by our daring dream of healthy humanity expanding to space.
ACCELLENA milestones
The core of the team has gathered and started to conduct international clinical trials for world's top pharmaceutical companies in Eastern Europe.
Feb
2005
2005
Inception
ACCELLENA company has been established and started its first international clinical trial for anti-cancer orphan drug in the USA and Europe.
Apr
2015
2015
Foundation
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.
Sep
2018
2018
Exploration
ACCELLENA conducted more than 70 various clinical trials of all phases (including large phase III study, first-in-human vaccination study and early pharmacology trial) with 15000+ enrolled subjects up to now.
Jul
2023
2023
Evolution
ACCELLENA milestones
The core of the team has gathered and started to conduct international clinical trials for world's top pharmaceutical companies in Eastern Europe.
Feb
2005
2005
Inception
ACCELLENA company has been established and started its first international clinical trial for anti-cancer orphan drug in the USA and Europe.
Apr
2015
2015
Foundation
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.
Sep
2018
2018
Exploration
ACCELLENA conducted more than 60 various clinical trials of all phases (including large phase III study, first-in-human vaccination study and early pharmacology trial) with 15000+ enrolled subjects up to now.
May
2022
2022
Evolution
We are the people of Accellena
Accellena Regatta 2022
- Konstantin ZakharovManagement Board"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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