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Congenix Adds Russian Presence to Health Decisions’ Agile Clinical Network

Carolina Headlines - Healthcare/Pharmaceuticals

DURHAM – Health Decisions (www.HealthDec.com), a full-service clinical research organization (CRO) specializing in high-efficiency adaptive solutions, announces that Moscow-based CRO Congenix has become a certified member of the Agile Clinical Network a community of research partners formed to eliminate the information gaps and prolonged timelines inherent to complex global studies. Congenix joins a group of like-minded CROs employing agile clinical development Health Decisions’ method of combining adaptive design and adaptive operations in a drive to cut timelines and increase transparency for multinational trials.

Congenix completed an in-depth training program that covers every aspect of agile clinical development, focusing especially on adaptive operations and infrastructure. This training is mandatory for all network members, and ensures that all CROs operating in the network adhere to the same stringent standards and guidelines.

“Conducting global, multi-center trials with a network of regionally focused CROs offers many advantages over a single large CRO with international offices,” said Vladimir V. Novakovskiy, M.D., Ph.D., managing director, clinical operations and regulatory affairs, Congenix, LLP. “We look forward to bringing our extensive knowledge of Eastern Europe and Russia to the Agile Clinical Network to better assist sponsors with assessing investigators, cooperating with the local regulatory bodies, and recruiting study subjects.”

According to Dr. Novakovskiy, Eastern Europe and Russia offer sponsors high recruitment rates, an excellent selection of high-quality investigational sites, and lower cost per patient compared to Western Europe and the U.S. Other benefits include Russia’s highly centralized healthcare system and a large percentage of treatment-naïve patients.

A UK-registered CRO with offices in Moscow and Hercules, Calif., USA, Congenix offers phase I to IV services including regulatory affairs, clinical monitoring, project management, investigational site management, study supplies custom clearance, warehousing, and distribution. Working within the Agile Network, Congenix will have access to Health Decisions’ and other members’ high-efficiency data management systems, biostatistics expertise, medical writers, advanced data collection tools, and real-time reporting capabilities, as well as regional infrastructure around the world.

“We welcome Congenix to the Agile Clinical Network and look forward to our working together on global trials that will maximize efficiency and transparency,” said Rick Farris, chief operations officer at Health Decisions. “Congenix will be a great asset to our Network as we expand its mission to deliver accurate trial results on an accelerated timeline, regardless of where a study is run.”

For more information, please contact Katie Hendrick, Marketing Specialist, by e-mail at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or by phone at +1.919.967.1111 x116.

To learn more about the Agile Clinical Network, see the press release announcing its formation on the Health Decisions Web site: www.HealthDec.com/page/international-cro-agile-training-press-release. You can also read about the certification processes and prequalification requirements at
www.HealthDec.com/page/agilenetwork.

About Health Decisions
Health Decisions (
www.HealthDec.com) is a global clinical research organization (CRO) committed to helping drug and device companies achieve greater success. Our sponsors rely on us to help them prove the value of their pipelines both faster and with the smartest possible allocation of funds. Through agile clinical development
a strategic combination of adaptive design and adaptive operations Health Decisions optimizes every facet of clinical research from design protocol to the most detailed day-to-day management, so sponsors can make the most of competitive market opportunities.

Health Decisions is headquartered in Durham, NC, with over twenty years of experience helping sponsors achieve success in phase I-IV trials across all major therapy areas. For more information, please visit the company's website at
www.HealthDec.com.

About Congenix
Congenix (
www.congenix.com) is a UK registered independent contract research organization (CRO) with expertise in conducting clinical trials in Russia and Eastern Europe. The company offers its clients a full range of services, using cutting-edge technology to provide high-quality results, on time and on budget.

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