Accellena | Services

ACCELLENA | through evidence to the stars

Eng

Rus

ACCELLENA
Research & Development
2022

>130

Completed and ongoing projects

>10 000

Subjects recruited in last 3 years

>50%

Annual revenue increase

+25%

FTEs annual growth

Non-clinical

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 R&D 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 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.

Our key capabilities:

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).

Over the years, Accellena R&D has investigated comparative pharmacokinetics of various dosage forms, including sprays, and has experience with studies featuring pharmacodynamic endpoints.

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

F-I-H, vaccine trial

WORLD FIRST SARS-CoV-2 VACCINE FIRST-IN-HUMAN STUDIES

Participants: 43+43 (healthy COVID-19 naïve subjects)
Average accrual rate: all in one week
Status: completed
Highlights: strict pandemic restrictions and subjects’ isolation.

The first two studies (two different forms of the Sputnik V vaccine) in humans were organized by Accellena in the midst of the COVID-19 pandemic. A features of these studies were extremely limited time resources and strict anti-epidemic measures in force at that time. The need for isolation and a strict anti-epidemic regime for subjects before the start of the study itself, with minimization of the risks of possible outbreaks of the disease among isolated subjects, has also become a significant difficulty. These obstacles required a major effort in the organization of the study, which eventually led to the success of both studies.

Publication

Comparative PK study

NASAL SPRAY AND SOLID ORAL DOSAGE FORMS COMPARATIVE PK STUDY

Participants: 35 (healthy subjects)
Average accrual rate: all in one week
Status: completed
Highlights: PK comparison of two different dosage forms with challenging dosing procedure

A comparative PK study, relatively simple in design, but challenging in terms of dosing procedure. This study compared IMP in tablet form to nasal spray form. The difficulty was the standardisation of the spray dosing procedure in the research centre, including its technical support. Solving these issues made it possible to successfully conduct the study, and register the product.

Publication

F-I-H in ICU conditions

MEDICAL DEVICE FOR cDNA RESORPTION IN PATIENTS WITH SEPTIC SHOCK

Participants: 20 (patients with septic shock)
Average accrual rate: 4+ per month
Status: completed
Highlights: Very serious condition and ICU environment

First-in-human study of the medical device for resorption of circulating DNA (cDNA) from the systemic circulation in patients with septic shock for prevention of acute kidney injury. A key feature of the study was its conduct in difficult conditions in intensive care units (ICU) in patients with septic shock on the background of COVID-19.

MERS vaccine

MIDDLE EAST RESPIRATORY SYNDROME (MERS) ADENOVIRUS VACCINE

Participants: 291 (healthy subjects)
Average accrual rate: 60+ per month
Status: completed
Highlights: Enrolment of healthy subjects by manageable cohorts and fast biosamples' logistics

Relatively large, placebo-controlled dose escalation phase I/II study of MERS (coronavirus) vaccine. A significant part of subjects have been studied for the parameters of the cellular response by various methods, including flow cytometry. This circumstance imposed special time requirements for the transportation of ambient blood samples from a research centre in one city to a laboratory in another. The solution lied not only in the plane of organising the controlled transportation of samples, but also in organising the work of the centre for subject management.

F-I-H, monoclonal antybody

SARS-CoV-2 MONOCLONAL ANTIBODY FIRST-IN-HUMAN STUDY

Participants: 101 (healthy COVID-19 naïve subjects)
Average accrual rate: 30+ per month
Status: ongoing
Highlights: strict pandemic restrictions and subjects’ isolation.

Cohort single dose escalation study of monoclonal antibody in COVID-19 naïve healthy volunteers. The challenge in conducting this study was to find and enroll naive subjects in the second year of the COVID-19 pandemic, nevertheless ACCELLENA succeded in maintaining a high recruitment rate.

Clinical trials

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.

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

International study

ORPHAN ONCOLOGY TRIAL

Participants: 58 (orphan disease)
Average accrual rate: 5 per month
Countries and sites: 5 /21
Status: passed to another indication
Highlights: orphan disease, different regions and investigative sites

Our first study ever and the first study for an orphan indication involving research centres in the US, Canada and Europe. This is a relatively small phase 2 proof-of-concept study with extensive use of biological markers and state-of-the-art technology. ACCELLENA have gone all the way from Scientific Boards and US FDA pre-IND meetings to interacting with specialised professional communities in the US, such as the Gynaecology Oncology Group (GOG) to successfully launch and execute the project.

The largest phase III trial for cUTI

ANTIMICROBIAL RESISTANCE TRIAL

Participants: 777 (hospitalised cUTI patients)
Average accrual rate: 20+ per month
Sites: 30+
Status: ongoing
Highlights: Large study with challenging biosamples logistic and central standardised assessments

The largest phase III clinical trial for hospitalised patients with complicated urinary tract infection (cUTI) investigating the efficacy of treatment designed to overcome antibiotic resistance for common nosocomial pathogens. The study includes 777 participants at over 30 research centres. A feature of this study, in addition to the relatively large number of patients, is the complex logistics of biological samples, central evaluation and standardisation of laboratory methods.

Rapid pace of recruitment

LARGE ANTI-FLU VACCINE PEDIATRIC TRIAL

Participants: 1660 (paediatric 6m+ population)
Average accrual rate: 500+ per month
Status: completed
Highlights: Large vaccine paediatric study with risk based approach and central statistical monitoring

The influenza vaccine study, one of many other large vaccine studies. In this project, we included 1660 children aged 6 months and over into the study in the shortest possible time. The main difficulty of this study was the need for operational verification and processing of the received data, the rate of growth of which was rapid due to the equally rapid pace of recruitment. We have implemented risk based monitoring solutions using statistical monitoring methods to maintain a high pace of the entire study preserving the quality.

Stress-induced insomnia study

INSOMNIA TRIAL WITH CENTAL POLYSOMNOGRAPHY

Participants: 212 (stress-induced insomnia)
Average accrual rate: 20+ per month
Status: completed
Highlights: Central polysomnography reading and assessment as a “bottle neck” and successful patients management

Stress-induced insomnia study involving over 200 maladjusted patients. This study included polysomnography at a specialised research centre using a central reading and evaluation procedure. Since this is a lengthy procedure, the main challenge was to coordinate the enrolment of subjects in all participating centres, taking into account the availability of the polysomnography facility, as well as to standardise the assessment of a rather subjective phenomenon of sleep.

Data Science

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.

Reflex IWRS.

Accellena R&D uses its own Interactive Web Response System (IWRS) called "Reflex".

The system allows to distribute subjects and form groups using various randomization methods, distribute investigational products by sites 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 DATA ANALYSIS

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)

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:

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.

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

Long follow-up with RECIST assessment

OBSERVATIONAL STUDY TO INVESTIGATE HORMON THERAPY OF BREAST CANCER IN REAL CLINICAL PRACTICE

Participants: 29 women with breast cancer on hormonal therapy
Accrual rate: 3 per month
Status: completed
Highlights: patient retention strategy and central RECIST assessment in settings of observational study

A remarkable study of the use of hormonal therapy in patients with breast cancer and study of the effectiveness of combined treatment when prescribing drugs that affect the hormone receptor status in real practice. A feature of this study was a long follow-up period for these patients, in many cases more than a year, as well as a centralized assessment of the response by RECIST. Within the framework of this study, interesting scientific data were obtained, which may become the beginning of a new direction in the treatment of tumors with a low level of hormone receptors, or that have lost sensitivity to hormone therapy already during treatment.

Study backed by pharmaeconomic analysis

CASE-CONTROL STUDY TO INVESTIAGATE ANTI-VIRAL DRUG FOR FLU AND COLD PREVENTION IN AUTOMOBILE PLANT

Participants: 2150 healthy subjects
Average accrual rate: all in one month
Status: completed
Highlights: classical epidemiological “Case-control” study with more than 2000 participants and pharmacoeconomic analysis

A large epidemiological case-control study involving all workers in an automobile plant. The prophylactic use of the antiviral agent significantly reduced the risk of acute respiratory infections and influenza by more than two times and led to significant savings in the company's funds, which was found out in the course of a pharmacoeconomic analysis.

Interesting features of this study were the design of the study, the participation of more than 2000 employees of the plant and the wide involvement of the enterprise's health centers in the process.

Publication

Study backed by pharmaeconomic analysis

CASE-CONTROL STUDY TO INVESTIAGATE ANTI-FLU VACCINE FOR FLU PREVENTION IN AUTOMOBILE PLANT

Participants: 2450 healthy subjects
Average accrual rate: all in two months
Status: completed
Highlights: classical epidemiological “case-control” vaccine study with more than 2400 participants and economic analysis

Large case-control epidemiological study involving all workers in a manufacturing plant. The use of the vaccine significantly reduced the risk of influenza by almost three times and led to significant cost savings for the enterprise, which was found out during the cost-benefit (cost-benefit analysis) analysis.

The interesting features of this study were the design of the study, the participation of more than 2400 plant employees, and the pharmacoeconomic analysis.

Publication

“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
info@accellena.com

88, lit.A., Sredniy pr. V.O.,
St. Petersburg, Russia,
199106

Kesklinna linnaosa, Vesivärava
tn 50-201, Estonia, Tallinn,
10152