Risk Assessment & Management

UBC is a recognized leader in the design and execution of programs to assess and manage safety risk, including Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs).

UBC has planned and executed more REMS programs than any other organization in our industry. Our experts participate in the development of regulatory guidance documents and are well positioned to understand risk assessment and minimization priorities established by authorities such as the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA).

UBC experts negotiate critical aspects of safety and risk management plans with regulatory authorities and have extensive experience implementing these programs in partnership with clients. UBC helps assess the effectiveness of risk mitigation programs by designing and deploying Knowledge, Attitude and Behavior surveys.

Our services include:

  • Development of Risk Evaluation & Mitigation Strategies (REMS) and Risk Management Plans (RMPs)
    • Authoring
    • Implementation Document
    • Review & Consult
    • Supporting Document
    • Tool Development & Testing
    • ETASU
  • Knowledge, Attitude & Behavior Surveys
    • Questionnaires and protocols – sample size, recruitment methodology, response measurements
    • Survey materials – recruitment collateral, websites, call center scripts, informed consent
    • Survey implementation – mail, online, telephone interviews
    • State-of-the-art web survey system
    • Integrated Voice Response (IVR) systems
    • Computer Assisted Telephone Interviews (CATI)
    • Compliant systems: 21 CFR Part 11 and HIPAA
    • Comprehensive results analysis
    • Design and execute Performance Linked Access Systems (ePLAS)
    • Design and execute integrated safety systems.
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Thought Leaders