Risk management, including risk assessment
and risk mitigation strategies, are core
business offerings supported by our depth
and breadth of experience and capabilities
in clinical medicine and epidemiology,
information technology, regulatory
practice, trade relations and distribution
logistics, Coordinating Center operations,
and project management. Since 1998, UBC
has designed and managed some of the
industry’s most complex risk management
programs including many programs to meet
post-approval regulatory commitments for
risk assessment and risk minimization. UBC
has designed, implemented and evaluated
more RiskMAPs and REMS than any other REMS
provider, having been involved in more
than 80 such programs. In addition to
developing Medication Guides and
evaluating their effectiveness, UBC has
content and graphics experts to develop
materials for education and outreach in
Communication Plans. We have designed
more than 20 programs with one or more
elements to assure safe use, with many
currently in the marketplace and others
under review at FDA.
- Our REMS Coordinating Center handles more than 500,000 calls annually from physicians, retail pharmacies and patients and has been operating risk management programs since 1998.
- Our proprietary REMS technology platforms have enrolled and/or tracked more than 1.2 million patients, 100,000 prescribers, and 65,000 pharmacies.
- We have enrolled and monitored almost every national distributor and regional distributor in the United States (US) for REMS programs.
- We participate with Sponsors in multiple Food and Drug Administration (FDA) meetings and teleconferences about designing and implementing REMS, particularly those with ETASU, and are often asked to address complex analytical and surveillance issues related to REMS on behalf of Sponsors.