This milestone validates Novum’s position as the most experienced Contract Research Organization (CRO) in performing clinical studies to support locally acting generic products.
Pittsburgh, PA (PRWEB) September 21, 2010
Novum Pharmaceutical Research Services, Inc. announced that regulatory approval has been received on the fiftieth (50th) locally acting topical product for which Novum has performed at least one of the clinical testing phases. This milestone is over and above Novum’s average of 60 ANDA approvals each year using more traditional bioequivalence testing procedures.
The most recent approval was based on a 750 patient Tinea pedis study conducted by Novum’s Division of Clinical Trials, which specializes in the monitoring and management of clinical endpoint studies. Established in 2001, Novum’s CT division has conducted clinical equivalence studies in multiple therapeutic areas including: dermatology, infectious diseases, allergies, gastroenterology, endocrinology, women’s heath, psychiatric disorders and most recently oncology.
“This milestone validates Novum’s position as the most experienced Contract Research Organization (CRO) in performing clinical studies to support locally acting generic products. Our unwavering commitment to excellent and innovative study design and execution provides our clients with the support they need to obtain regulatory approval,” said Dr Chris Hendy, President and Chief Executive Officer of Novum. “As the development of generic products requiring clinical studies results in ever more complex scientific challenges, this commitment will enable us, and our clients, to reach the next fifty even faster.”
Gail Gongas, Vice President of Novum’s Clinical Trials division added, “The breadth of Novum’s service offerings is the key. Our extensive experience helps the small to midsized Pharmaceutical company navigate the entire clinical program. We provide a fully integrated solution which includes study design, protocol writing, site identification, initiation and monitoring, data management, statistics, report writing and regulatory submission services.”
About Novum PRS
Novum is a contract research organization ("CRO") that provides clinical research, data management, statistical and reporting services to the pharmaceutical and related industries. Founded in 1972 it operates Phase I research facilities with a total of 550 beds in three USA locations. Novum’s expanding clinical trials management group, currently focuses on performing Phase II through IV clinical equivalence endpoint studies requiring large patient populations. Visit http://www.novumprs.com for more information.