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:
- Clinical pharmacology
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.