PRA Completes 20th First in Human Biologics Trial - Applied Clinical Trials

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
PRA Completes 20th First in Human Biologics Trial 600 Subjects Enrolled Over an Eight-Year Period


PRA Completes 20th First in Human Biologics Trial

600 Subjects Enrolled Over an Eight-Year Period

PR Newswire

RALEIGH, N.C., May 27, 2014 /PRNewswire/ -- PRA, a leading clinical research organization, today announced it has completed its 20th first in human trial with biologics. The milestone is the culmination of 600 subjects enrolled in over eight years of first in human biologics trials, including directly into patient experience.

Biologics represent an important class of agents with an increasing share in modern medicine, as a response to improved understanding of molecular and genetic bases of disease. With the increased number of biological compounds being developed, PRA is poised to provide its clients with a high-end Phase I unit capable of safely and effectively evaluating compounds.

"At PRA, we are extremely proud of our continued, successful delivery of clinical development services in this exciting and important field of medicine," said Ewoud-Jan van Hoogdalem, vice president, Global Scientific Affairs, Early Development Services. "With our focus on science, we are keen to work with our clients to design and execute programs that provide the best answers to the development questions for the product. All of our eight 'science embedded' Phase I units in the U.S. and Europe provide an excellent starting point for these programs."

About PRA

One of the world's largest CROs, PRA is transforming clinical programs through our people, innovation and operational transparency. Our 10,000+ employees operate in more than 80 countries, delivering a broad spectrum of full-service and Embedded clinical trial solutions that meet the demands of a diverse marketplace.

PRA's Early Development Services group is committed to the highest standards of clinical excellence and scientific expertise. With more than 1,000 staff, 500 beds, eight clinics and two laboratories, it is the most comprehensive early development organization in the world. From its state-of-the-art facilities, the group provides the pharmaceutical and biotech industries with the unique scientific environment required for complex compound development and testing in both healthy volunteers and patients. In addition, PRA's harmonized laboratory facilities in The Netherlands and the U.S. are situated close to the clinical facilities and are configured to fully support all clinical study requirements.

Over the last 30+ years, PRA has established a reputation for specialized expertise and success in a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. Our forward-thinking approach to clinical research innovation, customized recruitment strategies and technological advances continues to make a difference to healthcare patients around the world.

To learn more about PRA, please visit praintl.com, email clearlypra@praintl.com.

 

SOURCE PRA

ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

UPCOMING CONFERENCES

8th Annual Forum on Transparency and Aggregate Spend 2014
Washington, DC
August 18-20, 2014

eSource Data in Clinical Investigations
Philadelphia, PA
August 20-21, 2014

Pharmacovigilance 2014
Philadelphia, PA
September 10-11, 2014

Collaborative Research Summit
Philadelphia, PA
October 15-16, 2014

See All Conferences >>

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
87%
Borrow lightly from EMA's pathway program?
6%
Create entirely its own pathway program?
8%
View Results
Untitled Document

Click here