patient support programs

CRO in Russia - Clinical Excellence Group (CEG)

post marketing surveillance

post marketing studies

marketing observational research

post marketing observational study

psp in europe

patient enrollment

Why patient support programs in Russia?

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clineg.com/patient-support-programs

Patient Support Programmes

Your company will get a successfully conducted Patient Support Programme and a large set of accompanying documents.
On time and to high quality standards.
You will enjoy the quality and reliability of our services and our commitment to result.

What about Patient Support Programmes?
A Patient Support Programme (PSP) is an organised system, where a Marketing Authorization Holder receives and collects information relating to the use of its medicinal products / medical devices.

Examples are:
✔ post-authorisation programs;
✔ disease management programs;
✔ surveys of patients and healthcare providers;
✔ information gathering on patient compliance;
✔ compensation/ reimbursement schemes.

Here are four key goals of PSPs:
✔ to support patients and help them take their medications as prescribed (compliance / adherence);
✔ to help patients understand their condition and provide advice on managing disease;
✔ to provide a service or financial assistance, or reimbursement support for patients also known as Patient Assistance Programs;
✔ to assess safety / adverse events.

Read more on the following web resources:
Patient Prefer Adherence. 2016; 10: 711–725
Pharmaceutical Information and Pharmacovigilance Association (PIPA, UK)
Journal of Managed Care and Specialty Pharmacy 2017; 23(8): 859-867
KPMG 2015
PharmaPhorum 2016
RDMag 2016
CEFAR / EMEA 2013
EMEA 2011

Why PSPs 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 establishing of PSPs in Russia are the following:
✔ A large proportion of patients are "naive", i.e., do not take any drugs or receive any other treatment before they were recruited in a PSP. It means, 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 PSP can often be a wonderful opportunity to receive comprehensive medical care.
The population is highly educated, which is beneficial for participants' compliance with a PSP 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 / hospitals / clinics succtssfully passed through inspections and Sponsors' audits.
The costs of PSPs in Russia are significantly lower than in the EU, the US, Japan, Australia etc.

Are these obvious advantages compatible with high quality of PSPs?
Yes, see the details below.
CEG collaborates with CEBIS International Srl., a Swiss Contract Research Organization, operating in 20+ countires of the European Union (EU) since 2007.

As part of the services that CEBIS is offering, PSPs-related ones have been developed in order to help pharmaceutical companies respond to their commitment to patients and to further understanding of severe diseases, to support a number of programs for patients and their families.

In terms of quality management, CEBIS is an ISO-certified company by UKAS, for the following management systems: 9001:2008 – Quality Management System; 27001:2013 – Information Security Management System.

For PSP Projects in Russia:
CEBIS is responsible for the CEBIS IT Platform development, participate in the development of the project-specific version of the IT Platform, and provide comprehensive consulting on the PSP design and methods, IT platform use, technical support.
CEG will be responsible for all the project-related activities, except for the
IT Platform Development.

CEG uses the CEBIS IT platform for Patient Support Programmes and Non-Interventional Studies, developed by CEBIS International Srl, Switzerland, 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 PSPs in Russia + EU countries in accordance with the local and international requirements.

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

Visit CEBIS International website.
Why CEG?
Quality, duration and costs of a PSP Project are crucial because they directly determine its practicability, payback period, 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 a successfully conducted Patient Support Programme in Russia / in Russia + EU countries, and a complete set of accompanying documents.
On time and to high quality standards.
You will enjoy the quality and reliability of our services and our commitment to result.
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 Patient Support Programs (PSPs) depends on Your Company's goals, deadlines, resources.
We organize translation of all source documents into / from Russian.
We develop Clinical Sections of Dossiers for PSPs in target countries, including Protocol, Patient Information Sheet with an Informed Consent Form, Brochure etc.
We develop complete set of documentation before, during and after PSPs
We hire and train Core Project Staff (Project Manager, Project Associates, Clinical Pharmacologist, Pharmacovigilance and Adherence Officer, Clinical Psychologist, Logistics and Monitoring Coordinators, IT Support Coordinator, Data Managers and Biostatistician, ADS Team).
We find Investigation Sites (ISs, Research Centers), obtain necessary documentation from them and their Independent (Local) Ethics Committees (IECs), find and recruite qualified staff in territories (doctors and nurses).
In collaboration with CEBIS, we develop and implement Project-specific IT Platform for PSP Data Management.
We carry out all stages and activities of PSPs, including Patient Recruitment, Monitoring (including Site Mointor Visits), Health Insurance, Pharmacovigilance, Logistics, QA / QC.
We perform comprehensive Data Management and Statistical Analysis.
We develop PSP Reports.
We deliver complete set of PSP documentation to the Sponsor.

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 a PSP.
Executive staff and key specialists of CEG have profound knowledge and vast experience in clinical, non-interventional and marketing studies.
Our Partner in the EU, CEBIS International, also has outstanding experience in PSPs and 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 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 10-21 days after contacting us and discussing the details.
We know, that it is crucial to understand, what investments are needed and at what stages and how long PSPs will take.
And yes, it is free of charge.
We are cooperating with 15 companies.
We have 19 completed Clinical Trials and 4 Non-Interventional Studies in our portfolio.
Our Partner, CEBIS International, completed 6 PSPs in the EU, including one for 4 500 patients.
You use the CEBIS IT Platform for PSPs.
We apply the CEBIS IT Platform , developed by CEBIS International Srl, Switzerland, installed on a server located in Russia, in accordance with the current federal legislation of Russia for Personal Data Protection (categories 2 and 3).
This is an additional guarantee of your projects' success.
Unique expertise in data management, biostatistics and medical writing.
Our team includes 6 unique medical writers and biostatisticians - there are only few such professionals in Russia and bordering countries.
And yes, we also develop study documentation in English.
Right proportion of price and quality.
The cost of a PSP depends on multiple factors. Anyway, our prices are 2-5 times lower than those of International CROs.
We need just 10-21 days to communicate you the precise cost for your PSP.
The affordable costs of our services combined with their high quality are a strong argument to work with us.
Our team is constantly improving, so your project has every chance of success.
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.
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.
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.
2-5 times more profitable!
Our knowledge of the market and experience in tenders allow us to argue, our prices are 2-5 times lower than those of large 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 Patient Support Programmes (PSPs) 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.
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