Design and conduct of studies, regulatory support, and IT solutions in the field of rare diseases to improve the quality of life of patients with rare diagnoses
Research services
Preclinical studies
Conducting comprehensive preclinical studies focused on the safety and efficacy of drugs for orphan diseases
Clinical studies
Full cycle of clinical trials Phase I-IV considering the specifics of rare diseases and limited number of patients
Bioequivalence
Conducting bioequivalence studies for orphan drugs using modern analytical methods
Drug registration
Registration of medicinal products and pharmaceutical substances, making amendments to regulatory documentation in the Russian Federation
Preclinical and Clinical Research. RWD&RWE
We provide a full research cycle for rare diseases, starting from preclinical studies through to the final clinical report. At the preclinical stage, special attention is given to safety, quality, and efficacy of medicines in accordance with Russian legislation and international standards. We conduct studies of reproduced and generic drugs with consideration of specific bioequivalence requirements, develop study designs for novel molecules including innovative therapeutic approaches, and organize specialized projects for biological medicines. All stages are supported by thorough analytics, monitoring, quality control, and reporting to regulatory authorities.
Clinical trials of phases I–IV are designed with the specifics of rare diseases in mind, where the limited number of patients requires particularly careful organization and personalized support of each participant. Our team ensures the development of study programs and protocols, interaction with ethics committees and the Ministry of Health, data management in dedicated EDC systems, as well as logistics, storage, and accountability of investigational products. Compliance is a core part of our approach: standard operating procedures, staff qualification, information security, and corporate policies guarantee the highest level of reliability. With experience in more than 20 international projects and a strong network of leading national medical research centers and regional clinics, we build the scientific foundation for further drug registration and ensure alignment with the highest quality standards
Standarts and policies
Information on the company’s SOPs, data protection, and anti-corruption policy.
SOP Development
Development and implementation of standard operating procedures to ensure the quality and efficiency of research.
Data Protection
Ensuring the security and confidentiality of research participants’ data in accordance with international standards.
Anti-Corruption Policy
Development and implementation of measures to prevent corruption in the process of conducting clinical drug research.