Conducting Clinical Trials
Phase I and Bioequivalence Clinical TrialsCerta Clinic offers a range of capabilities and advantages to ensure the proper and high-quality conduct of Phase I and bioequivalence studies:
  • Purpose-built and well-organized internal infrastructure
  • Full spectrum of necessary equipment
  • Experienced, specially trained team of physicians and nurses
  • Standardized blood collection procedures for volunteers
  • Streamlined logistics for biological samples from collection to plasma freezing
  • Specialized nutritional arrangements for volunteers in accordance with protocol requirements
  • Availability of an intensive care unit and anesthesiologists
  • Ability to rapidly organize new (exclusive) processes, procedures, or equipment procurement in accordance with clinical trial protocols
Clinical Trials at Certa ClinicOur Clinical Center conducts Phase II–III trials of new drugs and diagnostic methods in the following areas:
  • Therapy
  • Clinical Pharmacology
  • Cardiology
  • Neurology
  • Endocrinology
  • Gastroenterology
  • Dermatology
Phase I Clinical TrialsPhase I trials represent the first experience of administering a new investigational drug to humans. They are most often conducted in healthy volunteers. Phase I studies begin with assessing the safety and pharmacokinetics of a single dose, based on preclinical data from biological models. These studies provide preliminary information on drug tolerability, safety, and initial pharmacokinetics and pharmacodynamics in humans.
Phase I studies typically evaluate:
  • Safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose, including determination of the maximum tolerated dose
  • Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses
  • Bioavailability (absorption) of the investigational drug in humans
  • Pharmacokinetics and pharmacodynamics of single and multiple doses via different routes of administration
  • Drug metabolism and influence of body weight
  • Effects of age, sex, food, liver and kidney function on pharmacokinetics and pharmacodynamics
  • Drug-drug interactions
  • Key Features of Phase I Trials:Relatively small volunteer groups, usually fewer than 100 participants
  • Conducted in a single specialized clinic with proper infrastructure, equipment, and trained personnel
  • Study duration ranges from several days to several weeks
  • Volunteers are under 24-hour medical supervision, with all procedures carefully standardized
  • Advantages of Certa Clinic for Phase I Trials:Purpose-built infrastructure compliant with international standards for Phase I studies
  • Required equipment, including resuscitation equipment
  • Experienced, specially trained team of physicians and nurses
  • Standardized blood collection procedures for volunteers
  • Streamlined logistics for biological samples from collection to plasma freezing
  • Specialized high-quality nutrition for volunteers in accordance with the study protocol
  • Availability of intensive care unit and anesthesiologists
  • Ability to rapidly implement new procedures or procure equipment per study protocol
  • Capability for rapid volunteer recruitment
Completed Projects in 2025
Completed Projects in 2024
Completed Projects in 2023
© All rights are reserved 2025
  • Address
  • Moscow, 1-ya Kuryanovskaya St.,34, bld.2