A decision on the possibility of medical usage of the drug, i.e., launch onto the market, may be taken only after its systematic study in humans and on the basis of sufficient amount of information proving its efficacy and safety.
RDG organizes clinical studies in accordance with the principles of Good Clinical Practice and Russian legislation, international principles of GCP, ICH and FDA regulations. The main principle of our work in the field of clinical studies is strict compliance with legislation, confidentiality, patients’ rights and safety, and optimization of trial scale. Clinical studies are important for the future of medicinal product, this is part of the development of the drug, and in this regard we plan clinical studies so that their design, scale, results are sufficient for their full development and subsequent launch onto the pharmaceutical market of Russian Federation, as well as to allow for the possibility to use these results as promotional materials.
The results of local (conducted on the territory of Russia) clinical studies, bioequivalence studies, international studies with the participation of Russia as a member of studies are a mandatory part of the registration dossier and are required for product registration in Russia.
RDG Services:
- Clinical studies phase I-IV
- Bioequivalence studies
- “Observational” studies
- Epidemiological studies
- Pharmacoeconomic studies
Clinical studies services:
Project management
- Preparation of proposals for the product (trial scale / timelines / budget)
- Developing of control and monitoring system
- Preparation of trial documentation package
- Insurance of patients, volunteers, investigators
- Obtaining permission to conduct trial
- Obtaining import permission medicinal products
- Selection of clinical centers (feasibility)
- Training of investigational site personnel
- Pre-screening and screening of patients (based on own base of patients and volunteers)
- Qualification visit
- Execution of contracts, agreements
- Organization and conduct of the study
- Clinical monitoring
- Archiving of trial documentation
- Pharmacovigilance
- Quality control at all stages of the trial
Preparation of trial documentation
- Protocol
- Case record form
- Investigator’s brochure
- Patients’ information sheet and informed consent form
- Patients’ diaries
- Documentation on the transfer / storage of medicinal products
- Other supporting documents of the trial
Data processing
- Encryption of data
- Import / export of clinical findings and laboratory data
Statistical data analysis
- Development of study design taking into consideration statistical significance
- Determination of patient sampling size
- Choice of statistical analysis
- Data processing
- Preparation of interim and final statistical analysis
- Preparation of statistical report
- Archiving of data
Logistics
- Obtaining of permission for import
- Preparation of documents for customs clearance
- Customs clearance
- Delivery and storage of drugs and biomaterials
- Preparation of medicinal products for trial (labeling, packaging, etc.)
Estimated costs of clinical studies: from 1 000 000 rubles (the minimal scale for the registration of generic drug), may vary and depend on the scale of study, phase, duration, drug, pathology under study, frequency of monitoring, etc.