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Risk Evaluation & Mitigation Strategies (REMS)

Be Confident in Fulfilling Your REMS Obligations

Fulfilling FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) requirements for new and existing products isn’t something most sponsors have deep knowledge and experience with.

Having a trusted partner to design your REMS, guide regulatory interactions, oversee program execution, and manage the ongoing operations and evaluation of a REMS is critical. REMS programs also require unique technical experience and prowess to efficiently integrate into the healthcare system.

Why UBC is the Definitive REMS Service Provider

Administrator for Over 50% of Active REMS with 1 to 6 Elements to Assure Safe Use

Over 100 REMS Assessment Reports Submitted to FDA

REMS Center of Excellence handles 25,000+ calls per month; 88% of inbound calls answered <30 seconds

With experience on more than 120 risk management programs for products in a variety of therapeutic areas, UBC leads the market in providing integrated, comprehensive REMS services. Led by our team of epidemiologists, safety scientists, data analysts, software developers, psychometricians, and project managers, UBC has established a reputation among sponsors and the FDA as the leader in full-service REMS delivery.


Whether you believe a REMS is on your horizon or it has already been discussed with the FDA, we offer consulting on all aspects of your program and FDA interactions. We begin partnering at any time to review product benefit and risk, provide REMS design options, and ensure you are ready for REMS discussions as you move through approval.

Design, Implementation, & Assessment of a REMS

UBC is dedicated to the design, development, and deployment of technologically driven REMS services. We combine highly experienced leadership and best-in-class technology, to create, implement, and assess the effectiveness of REMS programs.

Our Core Capabilities
  • REMS Design
  • REMS Implementation
  • Knowledge, Attitude, & Behavior (KAB) Survey Design, Fielding, and Evaluation
  • Coordinating Center Operations (REMS Center of Excellence)
  • FDA Assessment Report Preparation

Project Management Organization (PMO)

When a multi-sponsor REMS consortium is considered, it is important to broker consensus on key topics among the sponsors in the single shared system REMS. By utilizing both UBC’s deep REMS experience and our PMO experience, sponsors have a single source of accountability, eliminating intermediary services and functions, and placing UBC’s experts in closer proximity to the work.

  • Governance & Program Charter
  • Sponsor & Third-Party Vendor Onboarding
  • Regulatory Reporting Oversight
  • Document Repository Management
  • Financial Planning & Management

Meet Our Experts

Dr. Annette Stemhagen

Chief Science Officer

Natalie O'Donnell

Head of Safety & Risk Management

James Shamp

VP, Data Intelligence & Program Analytics

Jason Leedy

Corporate VP, Technology Strategic Design & Innovation

Start the Conversation

Safety & Risk Management