Outsourcing Clinical Trials LLC – All Except Monitoring

We offer support during clinical trials and perform any other activities except project monitoring and medical management in Russia, Ukraine, Bulgaria.
Assigning us all matters related to regulatory, finance, logistics and other aspects of a clinical trial, the sponsor gets an opportunity to maximally focus on the matters of medical management of the project.
In the course of trial you employ your own PMs and CRAs. Your presence in the country is necessary only during the researchers' meetings and monitoring visits.
We take responsibility for all other activities from obtaining permissions of the Ministry for Health Protection and committees for ethics to import/storage of medications under investigation and assistance in coordinating efforts of the researchers.
There is a growing interest to the clinical trials performed by outsourcing part of the matters related to their implementation among pharmaceutical companies and large contracting research organization. The key driving factors of the growing interest of sponsors are, among others, achievement of optimally effective implementation of the medical part of research protocol by own resources and, thus, raising control over the project as a whole. Considerable cost-cutting and less time spent to manage logistics support of the project under tight timeframes and considerable competition - all these leads to using new job standards.
The company offers on a temporary basis high-skilled free-lance CRAs, who know in detail specifics of the country, where the trial is performed.
Our professional and committed management has a long-standing professional experience. The coordinators appointed for each investigation ensure most careful attention paid to the project, prompt impact and resolution of any matters.
We shall offer you an extensive database of the research centers of all medical specializations and profiles of professional researchers in Russia, Ukraine and Bulgaria.
Our company strictly observes all ICH GCP and SOP rules.

Regulatory Support
Obtaining approvals of central and local committees for ethics. Obtaining permissions to import/export medications under investigation and biologic specimen. Obtaining approvals to carry out trials in the Ministry for Health Protection. Obtaining approvals in the Pharmacologic Committee.

Finance Support
Funding research grants.
Payments to administrations of research centers.
Any other official payments to regulatory bodies, customs authorities and insurance companies.

Logistics Support
Providing fully certified and licensed warehouses to store medications under investigation. Services of specialized customs brokers. Control and distribution of the medications under investigation among research centers.

Monitoring Support
Assistance in selecting research centers.
Providing a fully-equipped workplace for your project manager or CRA for the time of their stay in the country. Assistance in coordinating activities of the researchers. Compiling and submittal to the sponsor all required research materials and vice versa.

Investigator Meeting
Inviting and gathering all researchers and representatives of the sponsor.
Developing and working out meeting schedule, advertising materials and other supporting information. Booking hotel accommodation, providing visa support, arranging travels. Simultaneous interpreting.

Insurance
Insurance for the patients participating in the research. Insurance for the medical researchers. Insurance of the medications under investigation during their transportation to the country of research. Insurance of the medications during their storage in a clinic or at a centralized storage. Coverage against any other risks and any types of insurance.

As well as:
Translating all research materials, reverse translations. Recommendations on marking primary and secondary cargoes. Certification of the imported equipment. Purchase and distribution of accompanying materials and various kinds of supplies. Legal support.

We provide full support of your project for the entire period of its implementation. The project coordinator assigned for each particular research ensures the following:

• Assistance in selecting research centers, purposing potential research centers and performing their joint appraisal.
• Preparing visit of the sponsor to the research center;
• Assistance in coordinating activities of the researchers;
• Compiling and forwarding to the sponsor the required informative materials from the research site and vice versa;
• Ongoing contacts with the entire team of researchers and administration of the research centers.

While staying in the country of research, your CRA or Project Manager receives:

• a fully equipped workplace;
• phone, fax, postal services;
• maximally speedy Internet;
• professional interpreter;
• constant attendance during all visits to research centers and any other meetings.

Please, contact us if you want to learn more about opportunities offered by the company.

For more information, please contact:

Dmitry Sharov
CEO
Outsourcing Clinical Trials Rus Ltd
52, Shpalernaja Str., Suite 307
St. Petersburg, East Europe 193015 Russia
Phone: 7-812 -326-2091
Fax: 7-812 -326-2091
E-mail:

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.

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Last updated on February 19, 2008

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