The EU pharmacovigilance framework has changed in ways that go far beyond routine compliance updates and the gaps regulators are scrutinizing are specific: third-party contract governance, signal management procedures, audit programs, and PSMF documentation. We've broken down the six requirements demanding immediate attention from MAHs, and what your team needs to do about each one. UBC has supported clients through 30+ regulatory inspections with zero critical findings. Read the full breakdown here: https://lnkd.in/gC7ZDQAS #Pharmacovigilance #EURegulation #PatientsFirst #Compliance
Sobre nosotros
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Underpinned by our scientific expertise, data and analytics, and innovative technologies, we offer our customers flexible solutions generating the relevant real-world data necessary to make more informed decisions earlier, meet stakeholder requirements, and ultimately, drive better patient outcomes.
- Sitio web
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http://www.ubc.com
Enlace externo para UBC
- Sector
- Investigación biotecnológica
- Tamaño de la empresa
- De 1.001 a 5.000 empleados
- Sede
- King of Prussia, Pennsylvania
- Tipo
- De financiación privada
- Especialidades
- Modernized Study Design & Execution, Late-Stage Research, Risk Evaluation & Mitigation Strategies, Pharmacovigilance, Patient Access & Hub Services, Reimbursement & Patient Assistant Programs, Nursing & Adherence y Evidence Development
Ubicaciones
Empleados en UBC
Actualizaciones
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UBC ha compartido esto
Monday Mastery: Stop Scrolling and Start Questioning: How I Read RWE! If I had a dollar for every time I heard “The p-value was 0.04, so the drug works.”, I’d be retired by now! In the world of Pharmacoepidemiology, a "significant" result is often just the beginning of the story—and sometimes, it’s a distraction from a flawed design. When a 100-page study report lands on my desk, I don't look at the conclusion first. I look for the Red Flags. I’ve put together a guide on the 10 specific warning signs I look for—from "Immortal-Time Bias" to the "Prevalent User Trap." Whether you are a clinician, a regulator, or a health economist, these are the tools you need to separate the scientific signal from the statistical noise. The "Real World" is messy. Your evidence shouldn't be. 👇 Check out my full breakdown of the 10 Red Flags below. #RWE #RealWorldEvidence #Pharmacoepi #HealthData #EvidenceBasedMedicine #DataTransparency #DigitalHealth
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Some work is done in offices. Some work is done at home. The best work is done in the moments between. A conversation in the hallway, a shared vision over coffee, a partnership that starts with a handshake. The UBC team is heading to Las Vegas for Asembia's AXS26 Summit (April 26–30) ready to connect with the people and partners who are shaping the future of specialty pharmacy and patient access. Because at the end of the day, it's never just about the work. It's about creating moments that matter. See you there! Come visit us at booth #1915. https://lnkd.in/gkC3-U_4 #AXS26 #Asembia2026 #UBC #PatientsFirst
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UBC ha compartido esto
I recently had the opportunity to attend Access USA in Philadelphia, and the conversations really stuck with me. Two phrases kept coming up: "calm the chaos" and "can't eliminate the human touch." In an industry moving quickly toward AI-driven solutions, those reminders felt timely. I shared my key takeaways in a new piece, covering AI's role in patient support, Hub program design, Medicare smoothing, and what it actually takes to build programs that work for patients. Read the post here: https://lnkd.in/g5A_ge89 and reach out to me directly or visit ubc.com to learn more about how UBC approaches patient access. I am excited to join the team next month at Asembia's AXS26 and continue the conversation. Set up a meeting and we'll see you there!
We're looking forward to connecting with colleagues, partners, and innovators at Asembia's AXS26 Summit in Las Vegas, April 26–30, 2026. Our team will be on the ground attending sessions, building relationships, and showcasing how UBC is advancing specialty pharmacy solutions. Come visit us at Booth #1915 or schedule time with our team ahead of the event: #AXS26 #Asembia2026 #PatientsFirst
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What if the stigma surrounding depression is as much a barrier to treatment as the condition itself? Our latest piece, authored by Judy Lytle, PhD, MBEE, PMP, examines how centuries-old beliefs about body, mind, and gender continue to shape who gets diagnosed, who seeks help, and who falls through the cracks. And whether psychedelic-assisted therapy, of all things, might be uniquely positioned to change that. Read it here → https://lnkd.in/gR4wrHpU #PatientsFirst #UBC
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UBC ha compartido esto
In my years as a pharmacoepidemiologist, I've learned that the biggest barrier to credible Real-World Evidence isn't data access—it's statistical literacy. Too often, I see critical decisions made based on misunderstood metrics. A p-value < 0.05 is treated as proof of causality. Odds ratios are reported as risks for common outcomes. Confidence intervals are ignored in favor of point estimates. In observational research, where bias often dwarfs random error, these distinctions aren't just academic—they impact patient care and regulatory outcomes. I've just published a new article: From Precision to Estimation: Real-World Evidence beyond P-Values. Inside, I break down the fundamentals we need to get right: 🔹 Risk vs. Rate vs. Odds (and why confusing them matters) 🔹 How to truly interpret Confidence Intervals 🔹 Why context dictates the value of a P-Value 🔹 Choosing the right Effect Measure (RD, RR, OR, HR) My goal is to move us from chasing "significance" to embracing "estimation", robustness, and clinical plausibility. 👉 Read the full article below. I'd love to hear from my network: What statistical concept do you find most frequently misinterpreted in RWE studies? Let's discuss in the comments. 👇 #RealWorldEvidence #Pharmacoepidemiology #RWE #Biostatistics #EvidenceBasedMedicine #ClinicalResearch #DataScience #RegulatoryScience #HealthData #CausalInference
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We're looking forward to connecting with colleagues, partners, and innovators at Asembia's AXS26 Summit in Las Vegas, April 26–30, 2026. Our team will be on the ground attending sessions, building relationships, and showcasing how UBC is advancing specialty pharmacy solutions. Come visit us at Booth #1915 or schedule time with our team ahead of the event: #AXS26 #Asembia2026 #PatientsFirst
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UBC ha compartido esto
I had the opportunity this week to attend Pharma USA in Philly, two days packed with incredible speakers, workshops, and conversations. Here are my key takeaways: 🔹Zero distance to the patient Across sessions, the industry acknowledged a hard truth: patients are often forced to be their own project managers. With ~35% drop‑off from prescription to fill, diagnosis deserts, pharmacy deserts, and fragmented handoffs, we have to look for ways to simplify journeys, remove friction, and architect care around real patient needs. Many manufacturers have launched direct-to-patient programs over the last year as another pathway to increase access. 🔹From activity metrics to outcomes that matter There’s a shift away from counting interactions toward measuring impact: diagnosis acceleration, time on therapy, adherence, and improved outcomes. The ultimate measure of success isn’t engagement, it’s patients diagnosed, treated, and improved. 🔹Evidence is the launch strategy Access is not “won” at launch. It’s shaped by how evidence is designed throughout development. Decision‑grade evidence must now support regulatory, clinical, and value decisions simultaneously, aligning the needs of providers, payers, and patients. 🔹Trust is the new differentiator Trust repeatedly surfaced as the #1 driver of patient engagement. Patients want plain‑language education, transparency around cost and coverage, and proactive support. Many are already using AI and digital tools to understand symptoms. Pharma must ensure credible, patient‑centric information meets them where they are. 🔹 Rare disease and specialty launches demand authenticity Early patient involvement, caregiver insights, real‑world data, and strong advocacy partnerships are no longer optional. Turning evidence into demand requires listening earlier, translating data into stories, and designing for adoption, not just approval. 🔹Breaking silos: zero barriers, zero waste The call to action was clear: redesign decisions and workflows (not tasks), stop legacy spend that doesn’t drive outcomes, and integrate clinical data, real‑world evidence, digital signals, and AI into a single evidence architecture. Overall, #REpharmaUSA reinforced that the future of pharma belongs to organizations that connect evidence to value, value to access, and access to real patient outcomes continuously, not sequentially. #REpharmaUSA #PharmaUSA2026 #PatientCentricity #EvidenceStrategy #MarketAccess #MedicalAffairs #RealWorldEvidence #DigitalHealth
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As psychedelics move closer to potential FDA approval, real-world care models offer important insight. Oregon’s psilocybin service centers have already implemented patient-centered approaches that emphasize preparation, safety, facilitator-client trust, and integration support. These early practices may help inform how psychedelic treatments are delivered once approved, particularly for conditions like treatment-resistant depression. Our latest post, authored by Judy Lytle, PhD, MBEE, PMP, explores what these centers are learning and how their experiences may shape the future of evidence-based psychedelic care. Read the blog: https://lnkd.in/gyBgiMmt #PatientsFirst
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UBC ha compartido esto
TOMORROW is the first ACRP Greater San Diego Chapter event of 2026 and we are so looking forward to it. You will not want to miss this remarkable group of expert presenters as they walk through how they are making a difference in a new wave of drug development! This event is free of charge but the first 10 folks to join the ACRP San Diego chapter will receive an additional incentive - want to know what it is? Well you will have to join us to find out. #SanDiego #UBC #biotech #pharmaceuticuals #clinicaldevelopment #regulatoryaffairs #medicalaffairs #pharmacovigilance #bionetworking #knowledgeispower
THIS WEEK ON BIOTECH BEACH! Get registered for the ACRP - Association of Clinical Research Professionals Greater San Diego Chapter March Program: "Where REMS Meets Reality - Psychedelics, Patients, and Clinical Trials" Date & Time: WEDS. 03/18/26 | 5:30 – 7:30 PM, PT AWESOME NEW LOCATION: Aquillius, 10918 Technology Pl, San Diego, CA 92127 Speakers: ✅ James “Bart” Bartelloni: Chief Revenue Officer, Harvest Connect, LLC ✅ Jamie Freedman: Executive Director, Head of Clinical Operations, Definium Therapeutics ✅ Rachel Bonfanti: Director, Risk Management and Scientific Consulting, UBC ✅ Cynthia LaCivita, Pharm.D.: CLL Consulting, LLC (former Director, Division of Risk Management, CDER, FDA) Sign up and bring a colleague! See you there! #clinicaldevelopment, #ProtocolDesign, #ClinOps, #UBC, Ryann Baudin, Michele Baptista, Jenn Salzetti Zeis, CCRA, CCRP, Eva Jiang, Fred Fowler, Jacqui Blem, Laurie Richard, Leif Erickson, Adriana G., Michael W. Young 📌, #psychedelics
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