Among the biggest of the four separate announcements on early phase research, PRA said it is opening an 11,000 square-foot outpatient facility at the company’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.
In addition, PRA is expanding Human Abuse Liability (HAL) study capabilities at its Lenexa, Kansas site. This expansion will help PRA to be the only CRO capable of conducting these specialized trials in more than one clinical pharmacology unit, the company claims.
Willem Jan Drijfhout, EVP of PRA Early Development Services, told Outsourcing-Pharma.com: “We see demand from clients changing from studies in healthy volunteers, to studies in special populations and patients. Over the past years we have built up significant patient Phase I capabilities and the current investments are designed to diversify in type of patients as well as in geographic region.”
The company also plans to expand its US patient capabilities and service offerings by implementing operational site models in its Marlton, New Jersey, facility similar to those in its pharmacology operations in Central and Eastern Europe.
Drijfhout added: “The operated site model we have been running for many years in Europe in our Patient Pharmacology Services (PPS) division allows us to be flexible both in size of study and type of patients researched, enabling us to build the most optimal operational setup for each individual trial. We expect that in applying this model to our New Jersey facility we will see similar benefits.”
The expansion of early phase services come as others in the space have seen an uptick in market demand, though pricing has yet to follow suit. Drijfhout told us, however, that the type of studies involved at the sites due for expansion “are special in nature and as a consequence have less pricing pressure associated with them than regular healthy volunteer studies.”
In addition to the US-based moves, PRA is expanding its Patient Pharmacology Services into Russia. The first clinical trial application was recently submitted for a rheumatoid arthritis patient study and approval is expected next month.
“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,” added Randall Hein, SVP, Clinical Research Services.
PRA’s EDS business unit’s global capabilities now include: eight clinical pharmacology units, two bioanalytical laboratories, as well as dedicated clinical pharmacology, statistics, data management and pharmacokinetics services.