NOVEMBER 1, 2018 – FARGO, ND –Novum Pharmaceutical Research Services, a leading U.S. clinical research company, hosted a delegation of eight US Food and Drug Administration (FDA) scientists from FDA’s Washington, DC, headquarters at its Fargo clinic on October 30th. Novum’s leadership and experience with designing, conducting, and analyzing topical corticosteroid studies led to Novum’s hosting the FDA team so FDA could observe Novum’s expertise in this area of research.
“We always encourage opportunities to have direct interaction with the FDA regarding important study topics to keep us at the forefront of the clinical research field” said Christopher H. Chamberlain, Novum’s Chief Executive Officer. “We were very proud to demonstrate our expertise in Fargo, and we always learn a lot from FDA as well in these face-to-face settings”, he added.
During the workshop FDA observed a live study in progress, used the Chroma Meters in a demonstration exercise, and discussed data collection, analysis and other topics with Novum’s senior scientific and operational staff. “We are very proud of our highly trained staff, who shined in front of this FDA delegation as they do when no one is observing” said Mike Hellman, Novum’s site manager in Fargo.
Over the last five years, Novum has conducted 293 Vasoconstrictor studies in Fargo for ANDA, NDA and 505b2 submission, collecting over 1.3 million site assessments of topical products. These studies have led to 22 regulatory approvals and many more pending applications for the US market. Novum also conducts many other study types at its Fargo, Houston, and Las Vegas clinics and has extensive experience with topical products in its late phase studies.
About Novum Pharmaceutical Research Services
Novum is a U.S. contract research organization (“CRO”) that provides Phase I through IV clinical research, data management, statistical and reporting services to the pharmaceutical and related industries. Founded in 1972, it operates Early Phase research facilities in three U.S. locations. Novum’s Clinical Trial Management group conducts Phase II through IV clinical endpoint studies requiring large patient numbers across numerous therapeutic areas. Please visit http://www.novumprs.com for more corporate information and http://www.gonovum.com to register and receive updates on study participant opportunities.
