- Q?Why use a CRO?
With the advent of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practices Guidelines, or ICH-GCP, the United States, European Union, Japan and other economies established a common format for the ethical and reliable conduct of clinical trials worldwide. Following these guidelines generally renders trial results acceptable for use in the registration of new products by the regulatory agencies of all nations. Utilizing these guidelines has allowed CROs to oversee the proper and ethical conduct of trials in new geographical regions where cost advantages exist for the sponsor. The CRO movement represents a quiet revolution in the efficiency of new medical product development.
CROs provide a variety of product development services to the pharmaceutical, biotechnology and medical-device industries, allowing their sponsors to manage product-development efforts more efficiently. The most basic service outsourced to a CRO is managing the interface between the pharmaceutical company and the physician investigators who will test their new product on appropriate subjects. The fundamental value proposition of the CRO to the pharmaceutical company (sponsor) is that trials conducted through CROs are completed an average of 30 percent faster than those conducted in-house. The average time savings of some four to five months translates into monetary savings, faster product registration, and thus increased revenue potential.
- Q?What medical disciplines are served by AmeRuss?
AmeRuss is capable of placing trials for sponsors for any discipline in medicine. The principals maintain personal contacts with experienced principal investigators in multiple fields at specialty centers of the Russian Academy of Medical Sciences and their network of affiliated hospitals and feeder clinics throughout the country. From oncology to pediatrics, cardiology to cardiovascular surgery, obstetrics and gynecology to numerous sub-specialties of internal medicine, AmeRuss has the contacts and capabilities to effectively place and bring trials to completion.
In addition, AmeRuss is able to work with all aspects of new medical treatments including small molecule pharmaceuticals, nutraceuticals, medical foods, genetically engineered biological molecules, and medical and surgical devices and techniques. AmeRuss will carefully evaluate all potential trial projects and provide clear analysis and feasibility projections to accomplish the sponsor’s goals.
- Q?What are the characteristics of Russia and selected regional countries that are favorable to the conduct of clinical trials?
- Macro environment favorable to recruitment success.
- Large geographical area covered.
- Large number of highly motivated potential sites.
- Access to a large diverse patient population.
- Low ratio of clinical trials to overall population.
- Potential for expedited start up time
- Comparatively short regulatory approval process.
- High subject / site ratio.
- High percentage of drug naive subjects.
- Large standing patient pools for enrollment.
- Traditional low internal migration allowing for extended follow-ups.
- Russian patients tend to be very compliant and eager to participate.
- Quality characteristics
- All investigators are registered MDs.
- Investigators have been trained in GCP / ICH guidelines.
- Clinical Research Associates (CRAs) are qualified physicians in the area of the trial they monitor.
- FDA inspections of sites in Russia have required fewer corrective actions than FDA inspections in most other regions outside the US.
- Supportive infrastructure
- Centralized system of patient databases within specialized medical facilities for Oncology, Cardiovascular Disease, and other specialties.
- Patient protection is assured through the use of Local Ethics Committees (EC), National EC and Independent EC.
- Every subject who participates in clinical research is insured by trusted and secure local insurance companies.
- Presence of all major courier/trial supply networks for speedy drug delivery and bio-sample export.
- Macro environment favorable to recruitment success.
- Q?How is Russia different from other non-“western” countries for the conduct of clinical trials?
AmeRuss has heard concerns from sponsors regarding problems with trials in some developing countries and emerging economies. These concerns actually help distinguish Russia and select newly independent states from these areas.
- Russia has a functionally robust social healthcare system so that subjects are not isolated at the end of trials.
- Russian patients are not hospitalized for minor illnesses or non-invasive procedures creating the effect of Serious Adverse Events.
- Russian persons tend to report significant complaints openly to physicians and tend not to minimize symptoms nor exaggerate responses to “please the doctor”.
- Russian persons tend not to use available newer OTC medications unless advised by their physician.
- Q?In what other countries can AmeRuss operate beyond Russia?
While our reach across the expanse of Russia may be the ideal environment for trial enrollment, either alone or complementary to US investigative sites, AmeRuss can readily include participation of numerous sites in Ukraine, Belarus, and Kazakhstan, as well as coordinate contemporaneous clinical development work in several regions of the former Yugoslavia and Eastern Europe. AmeRuss also has reliable strategic affiliations for mutual cooperation in the Middle East, Latin America, and for focused access to minority populations within the USA.
- Q?About our name and logo type…
Our company name derives from the joining of the first four letters of America and Russia, with the shared “R” signifying our union for the purpose of Research. The bold, clean lines of our logotype represent our operational culture of transparency, clarity, and accuracy. The crossbars of the “A” and “R” express our motivation to bring vast clinical data to a fine point; the bright red color of this adornment speaks to the energy of our research teams.