Conducting Clinical and Pre-Clinical Trials
Pre-clinical Studies
Pre-clinical studies form the foundation for subsequent steps in the development and registration of a drug. These studies assess the efficacy and safety of the product. The quality and scope of preclinical research directly influence the later stages of drug registration, ensuring that the product meets high standards of safety and efficacy before being proposed for clinical use.
OUR SERVICES
PharmRegS offers a full range of services for organizing preclinical studies for both original medicinal products and generics:
- Selection of research center
- Study design development
- Determination of optimal study volume
- Organization of the experimental part of the study
- Preparation of preclinical study reports in accordance with the requirements of Russian Regulatory Authorities
For the registration of original drugs in Russia, the following studies are required:
- Assessment of general toxicity (acute, sub-chronic, and chronic toxicity)
- Study of cumulative effects
- Study of local irritant effects
- Evaluation of specific toxicity (allergenicity, immunotoxicity, embryotoxicity, teratogenicity, effects on reproductive function)
- Determination of specific pharmacological activity
- Study of comparative antimicrobial activity of antibiotics (in vitro)
For some products, pharmacokinetic studies (investigation of absorption, distribution, metabolism, and excretion of the drug) are additionally required.
Based on the data from preclinical studies, a decision is made regarding the possibility of conducting clinical trials.
If bioequivalence studies are planned, a comparative kinetics dissolution test and quantitative determination of the active substance in the compared products must be conducted prior to initiation, according to EAEU regulations.
Pre-clinical studies form the foundation for subsequent steps in the development and registration of a drug. These studies assess the efficacy and safety of the product. The quality and scope of preclinical research directly influence the later stages of drug registration, ensuring that the product meets high standards of safety and efficacy before being proposed for clinical use.
OUR SERVICES
PharmRegS offers a full range of services for organizing preclinical studies for both original medicinal products and generics:
- Selection of research center
- Study design development
- Determination of optimal study volume
- Organization of the experimental part of the study
- Preparation of preclinical study reports in accordance with the requirements of Russian Regulatory Authorities
For the registration of original drugs in Russia, the following studies are required:
- Assessment of general toxicity (acute, sub-chronic, and chronic toxicity)
- Study of cumulative effects
- Study of local irritant effects
- Evaluation of specific toxicity (allergenicity, immunotoxicity, embryotoxicity, teratogenicity, effects on reproductive function)
- Determination of specific pharmacological activity
- Study of comparative antimicrobial activity of antibiotics (in vitro)
For some products, pharmacokinetic studies (investigation of absorption, distribution, metabolism, and excretion of the drug) are additionally required.
Based on the data from preclinical studies, a decision is made regarding the possibility of conducting clinical trials.
If bioequivalence studies are planned, a comparative kinetics dissolution test and quantitative determination of the active substance in the compared products must be conducted prior to initiation, according to EAEU regulations.
Clinical Trials
A clinical trial is a scientific investigation in which people participate to evaluate the efficacy and safety of a new drug or to expand the indications for use of an existing drug. These studies are an integral stage in drug development worldwide, preceding registration and widespread medical use.
During clinical trials, an in-depth exploration of the new drug is conducted to obtain data on its efficacy and safety. Based on these data, authorized health authorities make decisions regarding the registration of the product.
OUR SERVICES
PharmRegS provides a full range of services for organizing clinical trials of medicinal products (Phase I-IV and bioequivalence studies) across various therapeutic areas.
Our priorities include careful selection of research centers, expedited patient recruitment timelines, and regular quality control of the research.
Areas of Clinical Research:
A clinical trial is a scientific investigation in which people participate to evaluate the efficacy and safety of a new drug or to expand the indications for use of an existing drug. These studies are an integral stage in drug development worldwide, preceding registration and widespread medical use.
During clinical trials, an in-depth exploration of the new drug is conducted to obtain data on its efficacy and safety. Based on these data, authorized health authorities make decisions regarding the registration of the product.
OUR SERVICES
PharmRegS provides a full range of services for organizing clinical trials of medicinal products (Phase I-IV and bioequivalence studies) across various therapeutic areas.
- Study design development
- Selection of clinical centers
- Preparation of study budget
- Project management
- Preparation of all study documentation
- Obtaining approvals from regulatory authorities and local ethics committees
- Training of research center personnel
- Data monitoring and verification of interim data at the clinical center level
- Monitoring of adverse event reporting and SAEs
- Management of the investigational drug, placebo, and comparative drug
- Study completion and center closure
- Data processing, statistics, and reporting
Our priorities include careful selection of research centers, expedited patient recruitment timelines, and regular quality control of the research.
Areas of Clinical Research:
- Therapy
- Dermatology
- Pediatrics
- Gastroenterology
- Gynecology
- Rheumatology
- Infectious Diseases
- Oncology
- Cardiology
- Allergology
- and other fields
Moscow, 117105, Varshavskoye Highway, Building 1, Block 6.
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