Safety & Risk Management
Reassurance for the real world
We build confidence for clients by providing unmatched expertise in patient safety, along with strategies and results that balance commercial goals with seasoned regulatory oversight.
Patient Safety at the Forefront of Innovation
UBC combines innovative technologies and epidemiological expertise to help mitigate risk and ensure patient safety while optimizing the commercialization and delivery of products to market. Our drug safety and global risk management solutions encompass the full product lifecycle, including comprehensive post-marketing surveillance and regulatory affairs support. UBC collaborates with clients to ensure the benefits of a drug or biologic outweigh its risk and are regulatory compliant, leveraging a high-touch, technology-enabled approach to collecting, managing, interpreting, and reporting drug safety information.
Deep Scientific Knowledge
UBC possesses deep scientific knowledge across a broad range of indications including rare and orphan diseases and cell and gene therapies. We understand the client’s needs regardless of whether your product is a new chemical entity, an advanced therapy medicinal product, or a generic or biosimilar. UBC’s expertise and transformative approach to pharmacovigilance and REMS planning creates significant value along the drug development pathway.
Integrated Solutions to Demonstrate the Safe Use of Products
We execute data-driven safety and risk management solutions to minimize patient risk. Our consultative approach addresses the critical need to identify the right data for the right purpose and help to make better, more informed decisions to demonstrate safety, efficacy, and value. With decades of experience in REMS planning, we help our partners manage risks and regulatory obligations with confidence. Utilizing UBC’s tenured drug safety expertise provides unmatched insights for informed pharmacovigilance decisions every step of the way.
Risk Evaluation & Mitigation Strategies
- REMS Consulting & Design
- REMS Implementation & Evaluation
- EU Risk Management Plans & Effectiveness Evaluations
Pharmacovigilance
- Full-Service Outsourcing
- Safety Case Processing & Reporting
- Literature Review
- Safety Writing
- Signal Detection & Management
Frequently Asked Questions
What does UBC's safety and risk management capability include?
Two integrated sub-capabilities: Risk Evaluation & Mitigation Strategies (REMS consulting and design, implementation and evaluation, EU Risk Management Plans, and effectiveness evaluations) and Pharmacovigilance (full-service outsourcing, case processing and reporting, literature review, safety writing, signal detection and management). The two work together because most therapies need both a coherent safety story and an operational system to maintain it through the lifecycle.
Does UBC handle both PV and REMS, or specialize in one?
Both — as separate but connected practices. UBC has decades of REMS experience (over 140 programs delivered, administrator for more than 50% of active REMS) and decades of full-service pharmacovigilance (around 70,000 cases processed annually, 30 inspections with no critical findings from 2018 through Q2 2025). Many sponsors engage for one; the value of having both available is that PV signals and REMS design influence each other.
How does combining PV and REMS in one partner help us?
Safety signals from PV — what’s actually happening in the real world — should shape REMS design and effectiveness evaluations. When the two functions sit in different vendors, that feedback loop slows down or gets lost in handoffs. With UBC, signal detection findings inform REMS modifications, REMS knowledge and attitude surveys inform PV risk minimization, and the benefit-risk story stays coherent across both.
What kinds of products is UBC's safety expertise built for?
All product types — new chemical entities, advanced therapy medicinal products (cell and gene therapies), biologics, generics, biosimilars, combination products, vaccines. Deep concentration in rare and orphan diseases, cell and gene therapy, and first-in-class molecules where adverse events are clinically serious and the safety story has to carry real consequences.
How does UBC balance commercial speed with regulatory oversight?
By designing safety as the foundation rather than the brake. Done well, foresight on safety lets programs move faster — regulators are clearer earlier, prescribers are confident earlier, patients reach therapy with less friction. Done poorly, the same activities create rework. UBC’s epidemiology-led approach is about anticipating what regulators will ask, not reacting to it.
What does 'data-driven' mean in practice for safety and risk?
It means using real evidence to make design choices — choosing the right data sources for signal detection, sizing REMS based on actual risk-of-interest patterns, evaluating REMS effectiveness with knowledge and behavior surveys rather than assumed compliance, and connecting the PV signal layer to ongoing benefit-risk reassessment. The infrastructure (Oracle Argus, validated literature and signal tools, REMS coordinating center) supports this; the people running it do the work.
How does UBC's safety work connect to the rest of the product lifecycle?
Safety doesn’t operate in isolation — adverse events shape evidence interpretation, evidence shapes regulatory expectations, regulatory expectations shape access and prescribing. UBC’s PV and REMS capabilities sit alongside Evidence Development and Patient Access so the same safety story can inform a payer narrative, an HTA dossier, or a prescriber education programme without being rebuilt from scratch.
Learn More About UBC's Safety & Risk Management Solutions
Interested in learning more about how UBC’s safety and risk management solutions can help you make more informed decisions earlier and meet regulatory requirements?
