Clinical studies

Clinical study is a scientific research study with participation of people, which is carried out with the intent to estimate efficiency and safety of a new medicinal product or extend the precautions for medical use of the already known medicinal product.

Clinical studies are internationally and inseparably associated with the manufacture of new medicinal products and are carried out prior to the approval of new medicinal products and their further wide medical use. During such clinical studies performance, new medicinal products are being studied for the purpose of obtaining new data pertaining to their efficiency and safety. These data allow the corresponding public health authority of RF (Minzdravsocrazvitiya Rossii) to make a positive or negative resolution regarding the possibility and advisability of these medicinal products further approval.

PharmRegS is a full-service partner for complete clinical development needs.  We provide therapeutic-area knowledge and advanced technology to deliver the proven clinical services for medicinal products studies in Russia. We perform clinical studies of original medicinal products and generics (phases I-IV), bioequivalence tests and tests of pharmaceutical products dissolution kinetics.

We work in different therapeutic areas such as dermatology, gastroenterology, rheumatology, cardiology, allergologia, oncology, virulent diseases and others.

Our priorities: careful choice of investigator sites, prompt subject recruitment, regular monitoring.

Our services:

  • Development of CT design
  • Sites selection
  • Drawing up CT budget
  • Project management
  • Medical writing (producing CIP, CT Protocol and other essential documentation: CRF, Investigator's brochure, Patient Information Sheet, Informed consent statement)
  • Regulatory approval
  • Sites personnel training
  • CT Monitoring
  • Monitoring of test results documents on adverse experience and serious adverse events (SAEs)
  • Study drug (placebo, comparator drug) accountability
  • CT and Study Center Close-Down
  • Statistic and CT final report

Our goal is - performance of high quality investigations in the shortest possible time at reasonable price!