PRA accelerates Phase I studies with Frontage Laboratories agreement

PRA International, a US-based clinical research organisation (CRO), has added analytical lab testing services to its Phase I-IV clinical trial services in North America by signing an agreement with Frontage Laboratories.

PRA's state-of-the-art clinical facility near Kansas City, Missouri, runs a multitude of Phase I and Phase IIa studies each year, with a particular focus on first in human studies and other complex PK studies.

By broadening its bioanalytical service portfolio, PRA now offers pharma and biotech sponsors and other CROs the ability to align clinical and laboratory processes, thus saving time. It already operates a comparable service in Europe.

Although PRA conducts clinical trials across a broad spectrum of therapeutic areas, it places particular emphasis on oncology, central nervous system, allergy/respiratory, cardiovascular disorders and infectious diseases.

Frontage Laboratories is fully compliant with cGMP/GLP regulations and under this new collaboration will offer specialised bioanalytical services through PRA. Pharmacokinetic and biostatistical consultancy and data support will also be provided under the agreement.

Frontage operates a bioanalytical and biomarker research centre near Philadelphia that houses 17 mass spectrometers and other state-of-the-art instrumentation.

Dr Wim Tamminga, senior director of PRA Early Development Services US clinical pharmacology centre, said the agreement with Frontage Laboratories would enable the company to accelerate its Phase I studies and allow sponsors to make better decisions earlier in the drug development process.

"Frontage is the right partner for this collaboration because they are already a well-established provider of cGMP/GLP compliant testing services," he said. "Quality of service, location and scientific knowledge are what make Frontage Laboratories the best collaborative partner for our bioanalytical services."

Song Li, chief executive of Frontage Laboratories added: "We look forward to building a collaborative relationship with PRA that not only streamlines project execution but also places a strong emphasis on project management."

PRA offers a broad array of services that encompass the spectrum of clinical development, from filing of Investigational New Drug (IND) and similar regulatory applications to product registration and post-marketing studies on a global basis.

The company has more than 3,300 employees on six continents.