observational study

CRO in Russia - Clinical Excellence Group (CEG)

non interventional study

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russian pharmaceutical market

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clineg.com/non-interventional-studies

Non-Interventional (Observational) Studies

Your company will get successfully conducted Non-Interventional (Observational) Studies of drugs, medical devices or food supplements. From idea to Final Report.
In English, Russian and national languages.

On time and to high quality standards.
You will enjoy the quality and reliability of our services and our commitment to result.

NIS for pharmaceutical and food supplements market
If Your Company operates on the pharmaceutical market, manufactures food supplements or medical devices for treatment or prevention, it may be important for you to solve the following tasks:
✔ To assess (revise, specify) safety and tolerability of a product that has already been on the market (this is often needed for marketing purposes);
✔ To analyze current practices in the prescription of a healthcare product or their combination in patients with a certain health condition;
✔ To assess prevalence and incidence in a certain target population;
✔ To investigate efficacy of a product, when random assignment of participants to groups (study arms) is not possible for either ethical or technical reasons;
✔ To determine main factors affecting the efficacy and safety of a healthcare product;
✔ To estimate risks and their reduction in certain study group(s);
✔ To validate a questionnaire or a scale for diagnostics of target health condition (for example, in order to promote the findings of clinical studies);
✔ And much more...
NIS for
In-vitro Diagnostics (IVD) industry
If Your Company has IVD medical devices in the portfolio (any devices for clinical laboratory and instrumental diagnostics), you may be interested in the following opportunities:
✔ To standardize a diagnostic method in the pre-analytical, analytical and post-analytical phases;
✔ To conduct full or partial validation of a diagnostic method (in compliance with the best international practices);
✔ To assess the precision, accuracy, repeatability, limits of measurement (sensitivity), linearity, reliability, reference ranges and other characteristics of test systems;
✔ To assess the prevalence and incidence in certain target populations;
✔ To assess the sensitivity, specificity, positive and negative predictive values of diagnostic and monitoring tests;
✔ To determine optimal cut-off points for diagnostic systems;
✔ Others.
What is NIS?
All these goals can be accomplished by Non-Interventional (Observational) Studies, which are widely used to assess the efficacy, safety and tolerability of drugs, medical devices and food supplements.

Common definitions indicate the following distinctive characteristics of such studies:
1. A medical product is prescribed in the usual manner in accordance with the terms of the marketing authorization.
2. Patients are assigned to a certain treatment based on common clinical practice rather than a study protocol.
3. No additional diagnostic or monitoring procedures are used. Data are analyzed by epidemiological methods.

Numerous types of NISs include:
✔ Post-Authorization Safety Studies (PASS);
✔ Post-Authorization Efficacy Studies (PAES);
✔ Drug Utilization Studies;
✔ Оther epidemiological studies (case-control, cohort, cross-sectional, case series studies).

Such studies do not require authorizations from national Regulatory Authorities in Russia and other EAEU countries.
Why NIS 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 NISs 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 NIS can often be a wonderful opportunity to receive comprehensive medical care.
The population is highly educated, which is beneficial for participants' compliance with the study 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 Investigation Sites succtssfully passed through inspections and Sponsors' audits.
The costs of NIS in Russia are significantly lower than in Western and Central Europe, the US, Canada, Japan, Australia etc.
Why CEG?
NISs need a special approach due to variability of designs, complex methods of planning, data analysis and assigning participants to groups, as well as due to technical challenges in conducting the studies.

This goes for preparing a Protocol, an Information Sheet with an Informed Consent Form, a Final Report and articles for publication, as well as for the process of collaborate with Investigation Sites (Research Centers / Hospitals / Outpatient clinics).

CEG collaborates with CEBIS International Srl., a Swiss Contract Research Organization, operating in 20+ countires of the European Union (EU) since 2007.

CEG uses the CEBIS IT platform for Patient Support Programmes and Non-Interventional Studies, installed on a server located in Russia, in accordance with the current federal legislation of Russia for Personal Data Protection (categories 2 and 3).

Moreover, CEG + CEBIS together are able to establish International NISs in Russia + EU countries in accordance with the local and international requirements.

See how our offer can solve planning and organizational challenges of Your Company's Non-Interventional Studies.
We guarantee: Your Company will get successfully completed Non-Interventional (Observational) Studies of drugs, medical devices or food supplements conducted in Russia / the EAEU / the EU.
From idea to Final Report. In English, Russian and national languages.
On time and to high quality standards. In compliance with local 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 Non-Interventional Studies (NIS) depends on Your Company's goals, deadlines, resources.
We provide consultation on NISs in Russia, the EAEU, the EU.
We organize translation of all documents into / from Russian.
We register the study and its findings in international registries (EudraCT, WHO ICTRP, clinicaltrials.gov).
We develop Clinical Sections of Study Dossiers in English and in Russian: Protocol, Patient Information Sheet with an Informed Consent Form, Investigator's Brochure etc.
We develop all the documents before, during and after NISs.
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 NIS participants (if needed).
We carry out all stages and activities of NIS, including Patient Recruitment, Monitoring (including Site Mointor Visits), Pharmacovigilance, Logistics, QA / QC.
We perform comprehensive Data Management and Statistical Analysis.
We prepare NIS Reports in compliance with requirements of Russia, the EAEU and international norms (if needed - FDA, EMEA etc.).
We deliver complete set of NIS documentation to the Sponsor.
We write articles for publication in scientific journals or media in Russian and English based on NISs findings.

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 your NISs.
Executive staff and key specialists of CEG have profound knowledge and vast experience in NIS, Clinical Trials and Patient Support Programmes.
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 an NIS 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 completed 4 NISs in Russia ordered by pharmaceutical companies.
On top of that, we have 19 сompleted 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.
Unique expertise in biostatistics, clinical epidemiology and medical writing.
Do you need to perform the validation and standardization of a diagnostic method?
Or to study characteristics of a test system in a certain patient or volunteer population?
Or to investigate the efficacy and safety of a registered drug?
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 NISs 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 NISs.
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
NISs, selection of Investigation Sites, logistics, drug circulation, pharmacovigilance and study participants' safety, conduct of Non-Clinical Studies, adverse event handling and many other activities.
This is an additional guarantee of your projects' success.
Our team is constantly improving so your project has all chances of success. 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 studies, regulatory affairs and data management attend workshops and conferences.
In 2012-2016, CEG successfully passed 5 audits by international Sponsors.
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.
2-6 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 3-6 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

It is easy, convenient and only takes a few minutes.
Please send us Your comments, questions, suggestions, details about Your Company and planned Studies and PSPs through this Form. Leave your contact information and we will respond within 24 hours.
Pass the quiz and find out the best option for your Studies and Patient Support Programmes
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