Pharmaceutical Risk Management Consulting

Consulting Solutions

Leveraging real-world evidence to provide expert solutions in drug safety, risk management, and pharmacoepidemiology

UBC experts provide product safety and effectiveness consulting to the pharmaceutical, biotech, and device industries. Our leaders are recognized throughout the world.  We incorporate an epidemiologic approach into our services and solutions to collect and analyze data on product safety, effectiveness, and value. Our scientists have designed and implemented many of the industry’s largest and most complex safety and risk management programs. Consulting includes strategy and study design to meet post-marketing requirements in the U.S. and the EU. Additionally, we offer software and services that provide rapid answers to safety and cost utilization questions.

For value propositions, we work with sponsors to refine the need, and then customize the data collection solution ranging from patient surveys to medical chart abstraction to cohort or registry data collection. We are also experts in time and motion studies to evaluate product impact on medical processes.

Our strategic consulting services help guide our clients in meeting regulatory requirements and commercial objectives for peri and postapproval studies, risk assessment, and risk minimization.

UBC Knows

Knowledge + Experience = Successful Solutions.  When your bring your product to UBC, it becomes our priority to find solutions that ensure safe product use, including developing Risk Evaluation and Mitigation Strategies (REMS) of all types, with a special focus on REMS with Elements to Assure Safe Use (ETASU), as well as risk communication strategies, education and outreach programs, and distribution solutions. Our Value Demonstration team designs and leads data collection to better understand the impact of your product in the real-world setting.

Our experts can help:

  • Identify products that require risk assessment or risk mitigation
  • Design, implement, and evaluate risk assessment and risk minimization programs to meet regulatory requirements
  • Design and implement disease and product registries to meet regulatory requirements and address commercial objectives
  • Examine real-world use of drugs and associated outcomes
  • Understand product safety issues and risk factors at the patient level
  • Prepare safety reports and manuscripts for regulatory, product marketing, and medical communications

UBC Understands

You’re looking for guidance that will help accelerate decision making and provide predictive insights. Our manufacturer partners have described us as nimble, flexible, and accommodating, as well as practical in our strategic approaches. We will do what it takes to develop proactive solutions that can dramatically impact your product’s potential.

UBC is differentiated in risk assessment and risk minimization by the number of programs we have designed, managed, and evaluated, as well as the resources behind delivery of these programs. Our unique assembly of scientists and experts in epidemiology, safety, clinical medicine, psychometrics, biostatistics, health policy, real-world evidence, and risk management reinforces our scientific and regulatory credibility and offers viable solutions.

Commitment to Success

We offer a solid base of “lessons learned” knowledge and experience from related products and markets. We have a strong history of designing, implementing, and evaluating more than 100 RiskMAP and REMS programs. We have unparalleled expertise in medical chart abstraction, time and motion studies, and patient surveys. Design and collection of evidence in the post-marketing setting is one of our core competencies.

Contact Us

Contact us to put our scientists to work for you.

 

Thought Leadership

E2B Gateway Speeds AE Submissions to Regulatory Authorities

Setting the Precedent in Patient Safety

Webinar: Preapproval Risk Mitigation Strategies & Proactive Safety Considerations

European Pharmacovigilance & Risk Management: 6 Industry Trends to Monitor

Pharmacoepidemiology - The Basics

Brochures

Risk Management & REMS Measured by Results

UBC Commercial Services

UBC Solutions