international clinical trials

CRO in Russia - Clinical Excellence Group (CEG)

CLINICAL TRIALS IN EASTERN EUROPE

clinical studies in Russia

clinical trials in eu

patient enrollment

clinical study data management

clinical study report

Why Clinical Trials in Russia?

CEG services

CEG advantages

CEG contacts

quiz and best solutions

clineg.com/international-clinical-trials

International
Clinical Trials

Your company will get successfully conducted International 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.

International Clinical Trials in Russia and the EAEU

Are you interested in establishing an International Clinical Trial (ICT) to high quality standards and on time? Or just a multicenter clinical study with a large number of participants? And you probably don't want to overpay for it? Give us just a little of your time and we will tell you about a new interesting solution.

In 2017, 281 Authorizations to conduct International Multicenter Clinical Trials have been issued in Russia, which equals 40% of all authorizations issued during this period. In Belarus and Kazakhstan, the number is even smaller.

Ongoing studies are, of course, more numerous. But they are still dramatically less numerous than in the European Union, the United States of America or, say, India.

This is particularly surprising, i.e. the overall population of the Eurasian Economic Union (EAEU) (including Russia, Belarus and Kazakhstan, Armenia and Kyrgyzstan) sums up to more than 185 million people. Why is it the way it is?

The main obstacle may be insufficient quality and guarantees of many research projects in the countries. And this opinion is not without reason.

There are often concerns about work of investigation sites (research centers), project teams, regulatory authorities and specialists in medical writing, epidemiology and biostatistics. Of course, these are successfully solved by international Contract Research Organizations. But is your company ready to bear highest costs of International CROs' services?

On the other hand, there are local companies, that conduct ICTs in Russia and Kazakhstan. But can you always be confident in the quality of their work? Can you rely on them meeting the deadlines?

Why Clinical Trials in Russia and the EAEU?

There are 143.5 million people in Russia (according to the Federal State Statistics Service as of August 1, 2013) and 185+ million people in all EAEU countries.

Key opportunities for the organization of Clinical Trials in Russia and the EAEU:
✔ 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 the EU, the US, Japan, Australia etc.

Are these obvious advantages compatible with high quality of studies?
Yes, see the details below.

Do you also need patient recruitment in European Union (EU) countries?

CEG collaborates with CEBIS International Ltd., a Swiss CRO, operating in 20+ countires of the EU.

Therefore, together we carry out ICTs in all EAEU + EU countries in accordance with all local and international requirements.

Contact Us and tell / write about your goals and plans.

Visit CEBIS International website.

Key Stages of an International Clinical Trial

An example valid for Russia

1

Development of plan and design of the International Clinical Trial (ICT).
Preparation of the dossier for receipt of CT Authorization from Ministry of Health of the Russian Federation (MH RF), including Protocol, Patient Information Sheet with an Informed Consent Form, Investigator's Brochure, Individual Record Form, etc.
Registration of ICT in International Registries.
Search for participating research centers in Russia.

2

Submission of the dossier to MH RF.
The review (examinations) of design and ethics.
Receipt of ICT Authorization from MH RF.
Purchase / Import of test drug(s), comparative drug(s), basic therapy drug(s), expendable materials (if required).

3

Submission of the dossier and receipt of ICT 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.

4

Recruitment of study participants.
Monitoring of ISs.
Data management.
Pharmacovigilance.
Circulation of drugs.
Logistics.
Assessment of patient compliance.
Document flow.
Project management.
QA / QC.

5

Completion of study recruitment.
Close-out monitoring visits to ISs.
Data management.
Database Validation and locking.
Developing / Participation in development of ICT Final Report, Safety, Data Management, Quality Reports, etc.
Completion of Sponsor and Investigator Files.
Submission of a ICT Final Report to MH RF / regulatory authorities of other countries (if needed).

Why CEG?

Quality, time line and costs of research projects are crucial because they directly determine the timeliness of the an ICT, its payback period, the efficacy of marketing activities and 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 an International Clinical Trial (ICT) successfully conducted in Russia / the EAEU / the EU, a prepared Report, and a large set of supplementary documents.
In English, Russian and national languages.
On time and to high quality standards.
In compliance with Russian / EAEU / EU / US regulatory requirements and international norms.
OR
Your Company can shorten the duration of your ICT and lower its costs by involving research centers in the countries with total population 185+ and 512+ million people.
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 International Clinical Trials (ICT) (Phases II-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 ICT.

We provide consultation on Russian / EAEU / EU regulations to manufacturing, quality, registration, clinical trials, nonclinical and observational studies, promotion of drugs.

We organize translation of all source documents into / from Russian.

We develop Non-Clinical and Clinical Sections of Dossiers to receive ICT Authorizations in target countries: 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 ICT Authorizations.

We develop all the documents before, during and after ICT: 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 ICT participants.

We submit Dossiers to appropriate Regulatory Authorities in paper and electronic formats, follow-up the review (examinations) process.

We receive ICT Authorizations from appropriate Regulatory Authorities 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 Russian, the EAEU, EU, US and international guidelines.

We deliver complete set of ICT documentation to the Sponsor

We develop Registration Dossiers (documents of the Administrative, Pharmaceutical, Non-Clinical and Clinical Sections - CTD, Modules 1-5) in compliance with requirements of Russia, the EAEU / the EU.
See the details

What you get when you work with us?

You use our broad expertise and individual approach to your tasks.
We work together to define your goals.
We develop an optimal plan and design of an International Clnical Trial.
Executive staff and key specialists of CEG have profound knowledge and vast experience in clinical studies and drug registration.
Our Partner in the EU, CEBIS International, has outstanding experience in ICTs and other biomedical studies in 20+ countries.
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 10-14 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 Trials 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.
CEBIS International completed 50+ clinical studies in the EU.
Unique expertise in biostatistics, clinical epidemiology and medical writing.
Do you want to establish an ICT with "complicated" 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 are 5-8 times lower than those of International CROs.
We need just 10-14 days to communicate you the precise cost for your ICT.
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.

3-8 times more profitable!
Our knowledge of the market and experience in tenders allow us to argue, our prices are 3-5 times lower than those of large Russian Contract Research Organizations (CROs).
And 5-8 times lower than those of International CROs!
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 International Clinical Trials rather than isolated services.

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