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Phase I clinical trials, phase II clinical studies (phase IIa, phase IIb trials), bioequivalence studies in Russia by regulatory CRO Pharegis in Russia

Early Phases Clinical Trials in Russia

Conduction of early phases of clinical studies in Russia is not very common since only limited number of clinical centers satisfy strict criteria for the early clinical stages.

Nevertheless Pharegis provides to our clients full service managing Phase I and Phase II clinical studies. Also we have one of the biggest database on healthy volunteers in Russia who can meet criteria for entering those sophisticated studies for Phase I.

Like for Phase III, for Phase I and Phase II clinical study projects we provide full scope of CRO services:

  1. Project management – from feasibility & budget assessment and choosing of the sites to site closure and submission of clinical study report to MoH;
  2. Checking special conditions to meet clinical site criteria for Phase I and Phase II; providing site audit;
  3. Clinical study monitoring;
  4. Preparation of clinical study dossier and professional medical writing;
  5. Getting regulatory approval for clinical study, study protocol, protocol amendments and other documents approval;
  6. Data management and full-scope biostatistics management;

Request us  free calculation of you study timeline and budget. Our experts will thoroughly analyse your project and then we discuss it in depth - that will bring you full understanding of the best way to move further. 


Pharma Regulatory News

EMA News

  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023, PRAC, 01/12/2023
  • Consumption of antimicrobials in animals reaches lowest level ever in Europe, , 20/11/2023
  • Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 November 2023, CVMP, 10/11/2023
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023, CHMP, 10/11/2023