Conduct of clinical studies.

The clinic has some opportunities and advantages for adequate and good quality conduct of a phase I trial and bioequivalence study:

  • Presence of the specially constructed and organized internal building infrastructure 
  • Presence of all necessary equipment
  • Specially trained, experienced team of physicians and medical nurses
  • Elaborated procedures for blood sampling in volunteers
  • Elaborated logistics of biosamples from blood sampling to plasma freezing 
  • Arrangement of specialized nutrition for volunteers in accordance with protocol requirements
  • Availability of an intensive care room and resuscitators
  • Possibility to arrange a new (exclusive) process, procedure of equipment purchase rapidly in accordance with a clinical study protocol 

On the base of the clinical center, phase I-III clinical studies of drugs and diagnostic methods in the following fields are carried out:

  • Therapy
  • Clinical pharmacology
  • Cardiology
  • Neurology
  • Endocrinology
  • Gastroenterology
  • Dermatology

Clinical studies

Phase I CS

Phase I Studies – the first administration of a new to humans. Most often, Phase I studies are carried out on healthy volunteers. Phase I studies bеgin from safety and pharmacokinetics of a single dose which is selected using data obtained on biological models. As a result of Phase I studies, preliminary data on drug tolerability, safety are obtained, and its pharmacokinetics and pharmacodynamics in humans are first described.

PhaseI studies examine:

  • Safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose, determine a maximum tolerable dose;
  • Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses;
  • Bioavailability (absorption) of a new drug in humans;
  • Pharmacokinetics and pharmacodynamics of a single and multiple doses with various routes of drug administration;
  • Drug metabolism and effect of body weight;
  • Effect of age, gender, food, hepatic and renal function on pharmacokinetics and pharmacodynamics of a single and multiple drug doses;
  • Drug interactions.

Phase I clinical studies have certain particularities:

  • Phase I clinical studies include a relatively small number of volunteers, usually, it is not more than 100 persons;
  • A study is carried out in one clinic – in a specialized institution with a definite infrastructure fitted with necessary equipment, and under supervision of a specially trained personnel;
  • Study duration varies from several days to several weeks;
  • Volunteers are monitored by medical personnel for 24 hours, all procedures are thoroughly standardized.

“Certa Clinic” LLC has opportunities and advantages for adequate and good quality conduct of a Phase I study:

  • Specially designated and organized internal infrastructure allowing to carry out phase I studies in accordance with global standards;
  • Necessary equipment including the one for resuscitation;
  • Specially trained, experienced team of physicians and medical nurses;
  • Elaborated and standardized blood sampling procedures in volunteers;
  • Elaborated procedure for biosample logistics since blood sampling from a volunteer till plasma freezing;
  • Arrangement of a specialized nutrition for volunteers in accordance with Protocol requirements; 
  • Availability of an intensive care room and resuscitators;
  • Possibility to arrange a new (exclusive) process, procedure of equipment purchase rapidly in accordance with requirements of a study Protocol;
  • Possibility to arrange a rapid enrollment of volunteers.