clinical trials in Russia

CRO in Russia - Clinical Excellence Group (CEG)

bioequivalence studies russia

Russian pharmaceutical market


clinical studies in Russia

clinical trials in eu

patient enrollment

clinical study data management

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Why Clinical Trials in Russia?

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Clinical Trials
in Russia

Your company will get a successfully conducted Bioequivalence Study or Phase I, II, III or IV Clinical Trial, a prepared Report and a large set of supplementary documents.
On time and to high quality standards.
You will enjoy the quality and reliability of our services and our commitment to result.

Goals of Clinical Trials
Local clinical studies are an essential stage of drug development and state registration. But not only that.

Already after drug registration, you may need to introduce changes to the "medical" sections of the Drug Label. Or you may need to elaborate the efficacy, safety, pharmacokinetics or pharmacodymanics of the drug, to get evidence-based marketing material for promotion purposes.

As you well know, registration and post-marketing clinical studies are conducted in all of these cases.

Clinical trial is a prospective study to determine the efficacy, safety, tolerability and/or efficiency of medical intervention referred to therapy, prevention and diagnostics of a specific disease state of an individual.

They can be conducted with the participation of patients and healthy volunteers.

Clinical trial of a drug is a study of diagnostic, health-promoting, preventive, pharmacological properties of drug during its use by an individual, including absorption, distribution, alteration and depletion processes by applying scientific estimation to receive evidence of the safety, quality and efficiency of a drug, data on adverse drug reactions of the human body, and interaction effect with other drugs and/or food stuff (from the Federal Law of Russia No. 61, 2010 "On Drugs Circulation").
Why Clinical Trials in Russia?
There are 143.5 million people in Russia (according to the Federal State Statistics Service as of August 1, 2013).

Key opportunities for the organization of Clinical Trials in Russia:
✔ A large proportion of patients are "naive", i.e., do not take any drugs or receive any other treatment before they were recruited in the study. It means that patient recruitment is much easier and FASTER due to a small number of rejections at the screening stage.
✔ For patients with severe diseases, participation in a clinical study can often be a wonderful opportunity to receive comprehensive medical care.
The population is highly educated, which is beneficial for participants' compliance with the trial protocol (patient compliance) and reduces the likelihood of loss to follow-up.
A genetic profile of the population and environmental conditions are similar to those in the countries of Europe and North America.
✔ Investigators and clinical research teams are highly qualified. Many research centers (investigation sites) succtssfully passed through FDA / EMEA inspections, Sponsors' audits.
The costs of clinical studies in Russia are significantly lower than in Western and Central Europe, the US, Canada, Japan, Australia etc.

Key Stages of a Clinical Trial

Development of plan and design of the Clinical Trial (CT).
Preparation of the dossier for receipt of CT Authorization, including Protocol, Patient Information Sheet with an Informed Consent Form, Investigator's Brochure, Individual Record Form, etc.
Registration of CT.
Search for participating research centers.
Submission of the dossier to the Ministry of Health of the Russian Federation (MH RF).
The review (examinations) of design and ethics.
Receipt of CT Authorization from MH RF.
Purchase / Import of test drug(s), comparative drug(s), basic therapy drug(s), expendable materials (if required).
Submission of the dossier and receipt of CT Authorizations from Independent (Local) Ethics Committees (IECs) of Investigative Sites (ISs).
Conclusion of Agreements with ISs.
Purchase of drugs and expendable materials.
Conclusion of an Agreement for mandatory insurance and Certificates of insurance, sending to ISs.
Conducting Site Initiation Visits to ISs.
Creation of a Sponsor File and Investigator Files.

Recruitment of study participants.
Monitoring of ISs.
Data management.
Circulation of drugs.
Assessment of patient compliance.
Document flow.
Project management.
QA / QC.
Completion of study recruitment.
Close-out monitoring visits to ISs.
Data management.
Database Validation and locking.
Developing of CT Final Report, Safety, Data Management, Quality Reports, etc.
Completion of Sponsor and Investigator Files.
Submission of a CT Final Report, as a part of the registration dossier to the MH RF / regulatory authorities of foreign countries (if needed).
Why CEG?
Quality, time line and costs of research projects are crucial because they directly determine the timeliness of the a drug's launch, its payback period, the efficacy of marketing activities and, consequently, sales.

You may be familiar with a situation when, contrary to your plans, the deadlines are tragically missed, the costs unexpectedly double and the quality of the work itself leaves much to be desired. In other words, attempts to solve your tasks lead to new issues.

Take a look at our offer and learn how to avoid difficulties and accomplish your goals.

See more about CEG.
We guarantee: Your Company will get a successfully conducted Bioequivalence Study or Phase I, II, III, IV Clinical Trial, a prepared Final Report and complete set of supplementary documents.
On time and to high quality standards.
In compliance with Russian / EAEU regulatory requirements and international norms.
Just let us know your goals and we will help you get there.

How can we help your company?

We develop a Project Plan, Design, Timeline and Budget of Clinical Trials (CT) (Phases I-IV, Bioequivalence, Therapeutic Equivalence) depends on Your Company's goals, deadlines, resources.
We provide consultation on manufacturing and quality of laboratory batches of drugs for Clinical Trials.
We organize import of non-commercial samples of drugs for CT.
We provide consultation on Russian and EAEU regulations to manufacturing, quality, registration, clinical trials, nonclinical and observational studies, promotion of drugs.
We organize translation of all source documents into Russian.
We develop Non-Clinical and Clinical Sections of Dossiers to receive the Ministry of Health's (MH RF's) Clinical Trial (CT) Authorizations: Protocol, Patient Information Sheet with an Informed Consent Form, Drug Label, Investigator's Brochure etc.
We develop Administrative and Pharmaceutical Sections of Dossiers to receive the Ministry of Health's (MH RF's) CT Authorizations.
We develop all the documents before, during and after CT: Trial Master File (Sponsor File and Investigator File), Case Report Forms, Letters etc.
We find Investigation Sites (ISs, Research Centers) and obtain necessary documentation from them and their Independent (Local) Ethics Committees (IECs).
We work on health insurance of CT participants.
We submit Dossiers to the MH RF in paper and electronic formats, follow-up the review (examinations) process.
We receive Clinical Trial (CT) Authorization from the MH RF and IECs.
We carry out all stages and activities of Clinical Trials, including Patient Recruitment, Monitoring (including Site Mointor Visits), Health Insurance, Pharmacovigilance, Logistics, QA / QC
We perform comprehensive Data Management and Statistical Analysis.
We prepare Clinical Trial Reports in compliance with requirements of the MH RF, the EAEU and international guidelines (if needed - FDA, EMEA etc.).
We deliver complete set of CT documentation to the Sponsor
We develop Registration Dossiers (documents of the Administrative, Pharmaceutical and Non-clinical and Clinical Sections - CTD, Modules 1-5) in compliance with requirements of the MH RF, the EAEU.
See the details

What you get when you work with us?

You use our broad expertise and individual approach to your tasks.
We will work together to define your goals. We develop an optimal plan and design of clincial trials.
Executive staff and key specialists of CEG have profound knowledge and vast experience in clinical studies and drug registration.
You can see for yourselves, when you receive answers to your questions or, for a start, take a look here.
You will know all details of your project before its start and before we sign a contract. More predictability - no worries!
You will be provided with a Budget and Timeline of your project in just 5-7 days after contacting us and discussing the details.
We know, that it is crucial to understand, what investments are needed and at what stages, how long Clinical Trials will take, and when exactly test drug and reference medicines will be needed.
And yes, it is free of charge.
We are cooperating with 15 companies and have 19 completed clinical studies in our portfolio.
Additionally, CEG executive staff and key specialists have organized 120+ Phases I to IV, BE, TE Clinical Trials of generic and original medicines in Russia, Ukraine, Belarus and Kazakhstan.
Unique expertise in biostatistics, clinical epidemiology and medical writing.
Do you want to establish a clincial trial with "difficult" design?
Such as in the fields of oncology, HIV, severe infection or non-communicable diseases, obstetrics and gynecology, brain disorders, severe infections, psychiatry?
Call or e-mail us and we will help you. Our team includes 6 unique medical writers and biostatisticians - there are only few such professionals in Russia and bordering countries.
And yes, we could develop dossiers and other files in English.
Right proportion of price and quality.
The cost of Clinical Trials depends on multiple factors. Anyway, our prices 2-4 times lower than those of large Contract Research Organizations in Russia.
We need just 5-7 days to communicate you the precise cost for Clinical Trials.
The affordable costs of our services combined with their high quality are a strong argument to work with us.
We carefully listen to our clients and usually respond to the query in 24 hours.
So you can always be sure that the solution of current issues is not being delayed.
CEG has standardized business processes, so that you can be confident in quality and timeliness of accomplishing your goals.
Our work is guided by standards established on the market of drug registration and studies.
This goes for development and implementation of 38 Standard Operating Procedures (SOPs) and Policies, 100+ Standard Forms, Logs and Tables that regulate organization, monitoring and audit of
Clinical Trials, selection of research centers, logistics, drug circulation, pharmacovigilance and study participants' safety, conduct of nonclinical studies, adverse event handling and many other activities.
This is an additional guarantee of your projects' success.
Our team is constantly improving. And we really mean it.
Six of our specialists have more than 7 years of work experience in pharmaceutical companies and international Contract Research Organizations, four specialists have more than 12 years of experience.
Our managers on non-clinical and clinical studies, regulatory affairs and data management attend workshops and conferences.
In 2012-2016, CEG successfully passed 5 audits by international Sponsors.
We hold semi-annual courses on Good Clinical Practice (extended GCP training) for the company staff and external attendees. Each course lasts 4 weeks and includes 14 three-hour sessions.
Every year our company's staff takes an assessment of knowledge of Standard Operating Procedures and the legislation of Russia and the Eurasian Economic Union.
2-8 times more profitable!
Our knowledge of the market and experience in tenders allow us to argue, our prices are 2-4 times lower than those of large Russian Contract Research and Service Organizations.
And 5-8 times lower than those of international Contract Research Organizations!
But, of course, high-quality solutions and solid guarantees cannot be cheap.
Keep in mind: we will provide you with a comprehensive solution that encompasses all stages of Clinical Trials rather than isolated services.

Contact Us

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