REMS Design and Evaluation
Risk Evaluation & Mitigation Strategies (REMS) Design and EvaluationGuiding manufacturers in meeting FDA requirements to ensure the benefits of a drug or biological product outweigh its risks
UBC is unequaled in its mastery of risk management. Our experts have designed and implemented many of the industry’s largest and most complex Risk Evaluation & Mitigation Strategey (REMS) programs.
What is a REMS?
A REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product. The Food & Drug Administration Amendments Act of 2007 (FDAAA) gave FDA the authority to require a REMS from manufacturers to ensure the benefits of a drug or biological product outweigh its risks.
We pride ourselves on our ability to provide the critical thinking behind your approach to the FDA, develop the REMS, implement the solution once it has been endorsed, and evaluate its effectiveness.
UBC has the strategic know-how, regulatory awareness, and credentials required to meet the needs of all stakeholders, including multi-disciplinary sponsor teams and regulatory agencies.
It is paramount to partner with expert advisors with the proven track record needed to design, defend, and implement your postapproval safety and risk management programs.
Our services include:
Development of REMS and Risk Management Plans (RMPs)
- Assessment of potential for REMS requirements and Consulting Solutions
- Recommendations for REMS elements and design
- Development, comprehension, and health literary testing of Medication Guides and other stakeholder educational tools
- Development of REMS Elements to Assure Safe Use
Knowledge, Attitude, & Behavior Surveys
- Questionnaires and protocols – sample size, recruitment methodology, response measurements
- Survey implementation – online, personal and telephone interviews
- State-of-the-art web survey system
- Computer-assisted telephone interviews (CATI)
- Compliant systems: 21 CFR part 11 and HIPAA
- Comprehensive results analysis
Successful risk management strategies not only include having the right people and processes in place; it also requires advanced technology capabilities. Our technology suite includes high-performance, multi-model applications for the collection, management, and reporting of healthcare data, including collecting enrollments or attestations from healthcare professionals and patients, distributing and inventorying program educational materials, providing program training, and designing and delivering standard and ad hoc program metrics and assessment reports.
Our technology platform’s flexibility and modular design enable us to handle complex requirements. We deploy the best-fit technology for each program’s requirements and environments.
UBC experts can help guide your commercialization strategy. Contact us to learn more.