Congenix is a contract research organisation located in Moscow, operating within the Commonwealth of Independent States (CIS) including Russia, Ukraine, Byelorussia, and Kazakhstan, as well as the CEE. We offer comprehensive services covering the organisation and implementation of Phase I-IV clinical trials for both American or European pharmaceutical and biotech companies.

Congenix was established in 2004 by well-qualified specialists from various branches of medicine, all with vast experience of international clinical trials. Since 2005, Congenix has been implementing clinical trials in oncology, dermatology and rheumatology. The company’s trials have been successfully audited by their sponsors. Not limited to these indications, the company staff also have expertise in cardiovascular disease, endocrinology, neurology, psychiatry and other therapeutic areas.

The company employs doctors with the highest qualifications, equipped with broad knowledge of different areas of medicine, whilst also being experienced specialists in clinical studies. The project manager is a specialist with seven-years’ work experience. Congenix considers international and regular domestic training of its employees as a prerequisite for achieving and maintaining the highest quality standards.

Our company operates in strict compliance with the ICH GCP standards, requirements of international regulatory authorities and all applicable industry standards – in collaboration with the proper American and European consulting companies.

Congenix takes complete responsibility for dealing with the regulatory authorities, thus ensuring that it obtains all necessary documents as quickly as possible and complies fully with legislative and regulatory requirements. Our strength is a well-established relationship with the local experts and permitting bodies.

Congenix is a client-oriented company. Prompt enrolment of patients is a determining and often crucial factor for success in clinical trials. For this reason we prioritise contact with investigators and potential study centres in our day-to-day business. We use a vast database of medical institutions located on both Russian territory and in other countries. We work with leading specialists in various branches of medicine, who have an impeccable reputation and extensive experience of international multi-centre clinical studies. Our database is constantly updated to include new contact details of investigators working in different regions. When the client demands it, Congenix conducts GCP training for investigators before the start of a study.

Our activities are concentrated in the area of clinical operation services. Through our tried and tested sub-contractor we provide our clients with data management, biostatistics and medical writing services.

Congenix offers an integrated package of customised services in Phase I-IV clinical trials:

·       Protocol and subject recruitmentfeasibility assessment

·       Investigator selection and investigational sites’ qualification

·       Regulatory affairs (regarding the countries of CIS and CEE)

·       Project management and clinical monitoring

·       Site management and grant/contract administration

·       Quality assurance and quality control

·       Medical writing

·       Data management biostatistics

·       Investigator training

For us, the most important elements of a successful long-term business relationship with our clients are:

• Complete understanding and agreement on goals and objectives
• Excellent communication with client
• Quality performance, regarding both work and results
• Flexible and specific approach to client

For more information, please contact:

Dr. Irina Dobreva

CEO

Congenix, LLC

14, Kolomensky Pr., Moscow 115446, Russia

Tel: +7 495 775 0263

Fax: +7 495 775 0264

Email: info@congenix.com

Web: www.congneix.com