Our Phase I Services include over 25 years experience in the conduct of bioequivalence/bioavailability studies, drug interaction studies, and safety tolerance studies. We regularly research study designs and write protocols for fasted, fed/fasted, and steady-state studies. In the past twelve months, approximately twenty products that were tested at Novum have received FDA marketing approval.

Novum has specialized expertise in the conduct of studies with topical products, both generic and NCEs (New Chemical Entities). Approximately eighty-five percent of the FDA approvals for generic topical corticosteroids result from studies conducted at Novum.

Novum's statistical department has extensive experience in the statistical analysis of bioequivalence and topical corticosteroid studies. Currently available and up-to-date versions of software packages such as SAS and P-Pharm enable us to provide rapid turnaround on data analysis.

The Novum independent Institutional Review board (NIIRB) reviews all protocols for studies conducted at Novum. In 1996, the FDA confirmed that the NIIRB meets all current FDA and ICH regulations and guidelines for IRBs. To ensure that your project stays on schedule, the NIIRB meets every two weeks and has the ability to hold extra meetings if necessary. Approval documentation is available within forty-eight hours of the NIIRB meeting.

Novum's philosophy is to remain focused on what we do best - the conduct and management of confinement research studies. We have developed relationships with analytical providers to ensure a seamless workflow on your project. Novum will coordinate with the analytical laboratory to get the right assay at the best price for your project.