observational study

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...

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.

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.

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.

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.