High-quality preclinical (non-clinical) studies are a critically important stage in the development of any new drug. They allow for a comprehensive evaluation of its properties before initiating human trials: determining the toxicity profile, establishing the dose-response relationship, identifying the most sensitive target organs, and studying aspects of pharmacology that cannot be investigated in clinical practice.

The team of specialists at ACCELLENA ensures the impeccable execution of preclinical studies, which serve as the primary predictive factor for the success of subsequent clinical trials. Our mission is not merely to collect data but to provide you with a comprehensive dossier that proves the safety and justifies the use of your product. This minimizes risks at later stages of development and protects your investments. ACCELLENA conducts non-clinical studies at one of Europe’s largest research centers, which integrates an animal breeding facility, a vivarium, and modern laboratories.

Since 2015, the company has participated in 60 bioequivalence (BE) studies, including trials with replicative design, pharmacodynamic endpoints, and fasting or fed conditions. In total, over 2,000 participants have been enrolled in these studies.

To date, the company has conducted 21 Phase I trials and 8 Phase I/II trials of small molecules and biological products. In total, over 3,000 subjects have been enrolled in these early-phase studies.

As early as 2019, a vaccine trial against Middle East Respiratory Syndrome (MERS) was initiated, which laid the groundwork for the success of the first two human clinical trials in 2020 of one of the world’s first vaccines against the novel coronavirus infection (SARS-CoV-2), "Sputnik V", under highly challenging conditions of epidemiological containment measures.

In total, over 5,000 volunteers have been enrolled in early-phase studies.

To date, the company has conducted 4 studies using real-world data.

The first of these was an investigation into the use of hormone therapy in breast cancer treatment. Despite the relatively small number of participants, significant attention was paid to the duration of health status monitoring and qualitative assessment of treatment response according to RECIST criteria.

Two other projects involved large epidemiological case-control studies evaluating the preventive efficacy of an antiviral agent and an influenza vaccine in large industrial cohorts (several thousand individuals).

Within these projects, challenges related to comprehensive data collection on disease incidence across the entire study population were successfully addressed.

Our team ensures impeccable data management in more than 110 projects involving over 26,000 participants — from Bioequivalence (BE) studies and Phases I-IV to RWE/RWD studies. We build databases that meet regulatory requirements through meticulous CRF design, medical coding, and adverse event (AE) or serious adverse event (SAE) reconciliation, strictly adhering to GCDMP standards and tight deadlines.

Deep expertise in biostatistics begins at the study design stage: we strategically select primary endpoints and optimize methodology to control costs, ensure sufficient study power, and anticipate regulatory challenges. We use validated software and ensure seamless interaction between the statistician and programmer, which guarantees audit-ready analysis and preserves data integrity. A wide range of professional software is used for data analysis, including SAS, SPSS, WinNonlin, and R, allowing us to select the most suitable tool for the tasks of each project.