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Bioequivalence studies, therapeutical equivalence trials, phase 1, phase II, phase III clinical trials for drug registration in Russia by CRO Pharegis

Obligatory clinical trials for registration of medicines in Russia

As you know well, Russia has its own procedures for registration of new medicines. One of those national features is registration clinical studies. Every drug product to be registered in Russia should pass local clinical study for its safety and efficacy (under GCP), unless its efficacy and safety had already been studied in multinational clinical study with participation of at least two centers in Russia.

Registration clinical studies

are not required only for very limited groups of medicines like locally confirmed orphan drugs (by separate regulatory procedure according to last amendment to the Drug Law in Russia since July 2015) or generic products having their full registered analogs on the Russian market for more than 20 years.

Clinical trials for registration of original product or biosimilar product in Russia

require extensive clinical study program that includes local phase I, phase II and limited phase III (the latter two phases can be combined into one clinical study in some cases).

Registration clinical studies for generic drugs

imply either conduction of a bioequivalence clinical study on limited number of healthy volunteers (in some cases – patients) or therapeutic equivalence study depending on drug formulation and Russian MoH guidelines for bioequivalence studies.

Requirements for conduction of a clinical study in Russia

are typical: Clinical Study Protocol, Case Report Form template (CRF), Investigator Brochure, Patient information leaflet with Patient consent form as well as Life and Health Insurance for subjects in Russia should be prepared in Russian language according to MoH official guidelines and National GCP standard.

And for any clinical study project  one should get optimal balance between official Russian regulatory requirements, specifics and possibilities of the clinical centers and patients on the one hand, and your business focus, priorities and market forecast, on the other.

You can contact us sending your request to to get fast and free feasibility assessment and calculation of the study budget and timeline. Thanks to our consultants and regulatory experts you will be able to discuss your project in detail for free - to get working solution and understanding of optimal perspective for your project.

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. 

Phase III clinical trials by CRO Pharegis

Clinical Studies of Efficacy and Safety (Phase III Clinical Trials) in Russia

Our department of clinical studies will deliver you full scope of services concerning Phase III clinical study projects in Russia - either participation of Russian centers in ongoing or planned Phase III clinical study or full scale multicenter clinical Phase III study in Russia.

All technical questions like biological samples logistics, additional laboratory tests, pharmacokinetic and/or genetic lab tests and screening, preparation of patient-friendly electronic CRFs in local language and many more.

We provide:

I. Clinical trial project management in Russia

We provide full scope of clinical study management:

  1. Clinical study feasibility and timeline assessment;
  2. Clinical study timeline planning, determining milestones and KPIs;
  3. Clinical trial budget assessment and allocation;
  4. Choosing of the optimal clinical study centers that have official MoH permission for conduction of particular types of clinical studies;
  5. Thorough independent audit of clinical centers in order to satisfy possible FDA, EMEA and local MoH inspections;
  6. Assessment of clinical centers laboratory and diagnostic facilities;
  7. Coordination with institutional review board (IRB) / independent ethics committee (IEC)/ ethical review board (ERB);
  8. Clinical site initiation, start-up meetings;
  9. Managing monitoring visits, managing monitors and data managers;
  10. Clinical study data management, clinical study statistics management;
  11. Clinical site closing;
  12. Preparation of clinical study report according to Russian MoH requirements and ICH GCP guidelines;
  13. Adverse events (AE) management;
  14. Serious adverse events (SAE) and AE reporting according to GCP, international, local and sponsors' SOPs;
  15. Clinical site materials logistics, import/export permissions and customs clearance, coordination of logistics to/from a central laboratory;
  16. Submission of clinical study report to MoH.

II. Clinical study monitoring in Russia

For phase III clinical study we provide very experienced clinical research associates and clinical project managers for every study. Every clinical study monitor at Pharegis has dozens of successfully finished projects in clinical centers all over Russian Federation,

  1. Covering more than 40 major regional centers;
  2. Covering virtually all therapeutical profiles;
  3. Have database on primary investigators and current status of all centers;
  4. Have direct communication with primary investigators and centers administration.  

III. Preparation of clinical study dossier and professional medical writing

Preparation of the clinical trial dossier is essential project since medical professional expertise, quality of medical writing as well as quality of professional translation are very important to both regulatory approval of clinical study and clear understanding of clinical study by investigators, study centers' administrative staff, laboratories, statisticians and data managers.

We prepare:

  1. Clinical study protocol that fully corresponds to regulatory requirements in Russia;
  2. Investigator brochure;
  3. Patient information sheet with informed consent;
  4. Case report forms (CRF), including eCRFs, translation and adaptation of sponsor's CRFs;
  5. Life and health insurance agreements with Ingosstrakh National insurance company for patients and volunteers (International patient insurance is not applicable in Russia);
  6. Clinical study report.

IV. Getting MoH regulatory approval for clinical study in Russia

We obtain:

  1. MoH regulatory approval for the clinical trial protocol;
  2. HA approval for patient informed consent;
  3. MoH ethical review board approval for clinical study in Russia;
  4. Clinical trial protocol amendments;
  5. MoH permissions for import and export of clinical study materials and more.

V. Data management and full-scope biostatistics management

VI. Clinical study materials logistics, storage and destruction

  1. Obtaining import and export MoH permissions for clinical study biological materials and equipment;
  2. Provision of cold chain conditions for biological samples logistics and storage;
  3. Cold chain monitoring;
  4. Customs clearance of biological samples logistics;
  5. Storage of clinical study biological materials and equipment.
  6. Destruction of materials according to GXP. 

Contact us to get fast and free calculation of clinical study budget and timeline. After signing of the Confidentiality Agreement and getting project information from you, our consultants will analyze your project in detail and provide you working solution with clear perspective of further steps for your clinical study project in Russia.