Preclinical and clinical studies

During our professional practice, we actively dealt with the scientific and research/pharmaceutical development of drugs and the related preclinical and clinical studies.

We offer the following services:

  • Project preparation and consultation, and representation of the client at the State Veterinary Institute when approving a menagerie for preclinical studies
  • Expert advice on the proposal, design, and carrying out of preclinical studies in accordance with the latest EMA requirements and, in the case of client´s requirement and interest, also FDA requirements
  • Expert advice on the proposal, design and performing of Phase I-III clinical studies for registration in accordance with the latest EMA requirements
  • Expert advice and representation of the client at CRO selection to carry out a clinical study
  • Representation of the client in communication with CRO that carries out the clinical study
  • Statistical processing of results
  • Support preparing publications