PRA Health Sciences Expands Global Phase I Patient Strategy
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PRA Health Sciences (PRA) is enhancing its global Phase I patient strategy and increasing its clinical footprint with the expansion of its Early Development Services (EDS). These initiatives are being undertaken in response to market demand to include patients as early as possible in early phase clinical trial development and include:
• Opening an 11,000 square foot outpatient facility at PRA’s Salt Lake City, Utah site, focusing on psychiatry, neurology, pain and multiple other therapeutic areas. The new facility includes a dedicated pharmacy, clinical lab and surgical suites.
• Further enhancing PRA’s U.S. patient capabilities and service offerings by implementing proven operational site models in our Marlton, New Jersey facility similar to those utilized in our Patient Pharmacology Services operations in Central and Eastern Europe.
• Expanding PRA’s Patient Pharmacology Services into Russia. The first clinical trial application was recently submitted for a rheumatoid arthritis patient study and approval is expected in April.
• Expanding PRA’s Human Abuse Liability (HAL) study capabilities at its Lenexa, Kansas site. This positions PRA as the only contract research organization (CRO) capable of conducting these specialized trials in more than one clinical pharmacology unit.
“With PRA conducting more than half of its Phase I/IIa studies in patients vs. volunteers, these initiatives will further enhance our U.S. patient capabilities and service offerings,” said Randall Hein, Senior Vice President, Clinical Research Services.
Arnoud Huisman, MSc, Senior Vice President Global Business Development, EDS added, “This increased capacity will allow PRA to meet the increased high demand for patient studies, HAL studies, pain and other indications.”
PRA EDS is a business unit of PRA Health Sciences, offering full service Phase I capabilities and Phase I-III patient site services. Global capabilities include: eight clinical pharmacology units, two bioanalytical laboratories, as well as dedicated clinical pharmacology, statistics, data management and pharmacokinetics services.