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ACM-Pivotal Celebrates Seven Years of Clinical Trials in Russia

ACM-Pivotal, the global central laboratory that continually defines the client-service standard with its inherently flexible approach, celebrates its seventh anniversary of providing central lab services for pharmaceutical and biotechnology companies, as well as contract research organizations (CROs), conducting clinical trials throughout Eastern Europe.

ACM-Pivotal conducted its first Russian study in 2000 and over the past seven years has maintained a successful track record by mastering local requirements and gaining extensive experience within the region.
The global central lab will be celebrating this milestone anniversary at the CEE Clinical Outsourcing Partnerships Conference 2007, Oct. 8-10 in Bratislava, Slovakia.

Expansion of clinical trials into Central and Eastern Europe began over a decade ago, starting with countries such as Poland and the Czech Republic.

Since this time, the political map in Europe has changed significantly, leading to further expansion into countries such as the Ukraine, Lithuania, Estonia, Latvia, Serbia & Montenegro, Bulgaria, Georgia and Romania.
ACM-Pivotal routinely supports clinical trials in all of these countries covering a wide range of therapeutic areas, such as oncology, cardiovascular and respiratory diseases, dermatology, diabetes and rheumatoid arthritis.
Managing Director Jerry Boxall explains the key reasons why Russia and Eastern Europe remains such an attractive market for clinical trials: patient recruitment and compliance linked to high quality investigator sites.

"Investigators and patients in Russia and other countries of the region are highly motivated to participate in clinical trials. Patients are looking for the best medical care available from highly-qualified physicians, whose compliance with protocols and procedures is often of a higher standard than that seen in Western countries." said Boxall.

"Patient recruitment is seldom a problem in this region, and in trials where there is competitive recruitment, we confidently expect that Russia will contribute more than it s share of patients for a trial." While there is a growing pursuit of emerging markets such as India and China, ACM-Pivotal anticipates that Eastern Europe will remain a significant region in the conduct of clinical trials in the foreseeable future.

ACM-Pivotal has established a reputation for excellence in this area, where the company secures a very high level of repeat business and is continually adding to its client base through word of mouth recommendations.
"We are very proud of our track record in this region and enjoy an excellent cooperation both with our clients and the investigators on the ground," added Boxall.

As the global central lab, ACM-Pivotal s role includes the provision of expert project management with efficient, standardized processes for the supply of materials, shipment and analysis of samples, and data reporting.
ACM-Pivotal has established good relationships with local couriers to ensure there are no delays in shipping samples.

The global central lab also understands the regulatory issues involved to help the sponsor or CRO to obtain the necessary import/export licenses.

By having all the paperwork pre-approved by the local customs office prior to shipping, custom clearance delays can be avoided, which can save weeks of time during a trial.

In addition, strong local knowledge is essential to enable the smooth handling of any unexpected interruptions to business, such as the recent short-term ban on diagnostic specimen shipments out of Russia.

ACM-Pivotal s extensive experience and excellent network of local contacts enabled clients trials to continue uninterrupted during this time.

ACM-Pivotal recently announced significant expansion to accommodate its current and anticipated growth of the business on a global basis.

Currently, the organization s global operations extend to more than 60 countries, including the Americas, Europe, including Eastern Europe and Russia, Australia, Asia, Israel and South Africa - with all tests conducted and managed from central lab facilities with seamless data management providing a single database.

Last year, the organization expanded its capabilities to conduct trials in India.

About ACM-Pivotal

ACM-Pivotal is the global central laboratory with an inherently flexible approach and a focus on precision to keep clinical research 



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