Clinical Leader

Why is choosing the “right” CRO still one of the hardest — and riskiest — decisions in clinical development? With proposals that rarely compare cleanly and assumptions hidden behind spreadsheets, many sponsors struggle to evaluate CROs with true clarity. But insights from $2B+ in vendor selections facilitated through the ClinAI platform show there is a more structured, data-driven way forward. Join us TOMORROW (12/1) for a discussion with Kalyan Obalampalli (KO) on how to transform the RFP process into a strategic evaluation of timelines, resources, readiness, and cultural fit — not just cost. You’ll learn how to: • Build RFPs that generate truly comparable, decision-ready CRO proposals • Replace guesswork with data-driven analytics for vendor evaluation • Strengthen accountability, transparency, and cross-functional alignment throughout selection 👉 Register here to watch the free webinar live or on demand: https://lnkd.in/eJs8neRm

Two Former FDA Chiefs, Two Very Different Warnings In the span of just weeks, Scott Gottlieb and Robert Califf delivered two very different messages about the future of clinical research — and together, they paint a stark picture of what’s coming for ClinOps, sponsors, CROs, and health systems. Gottlieb warns of a leaner, overstretched FDA: slower guidance, tougher reviews, and less clarity at a time when teams desperately need it. Califf, meanwhile, zooms out: the real threat isn’t the regulator — it’s the system. >A healthcare ecosystem structurally incapable of learning from itself. >Clinical trials drifting further from real care. >Complexity and fear replacing judgment. >And a nation spending $5T on healthcare while delivering the worst survival in the high-income world. Read the full article by Chief Editor Dan Schell: https://lnkd.in/eDHbkj3z 📩 For more clinical trial insights, subscribe to the Clinical Leader e-newsletter: https://lnkd.in/etadaKdf?

Stop Protocol Amendments Before They Start Julie Smiley of CDISC explains how digital protocols can revolutionize protocol feasibility by running eligibility criteria through EHR systems to identify potential patient populations up front. She discusses how this approach addresses the major cause of protocol amendments — patients not meeting eligibility criteria — and supports quality by design principles. Watch the segment: https://lnkd.in/e7ycYyaY

Learn how structured RFPs, data-driven analysis, and stakeholder alignment can turn CRO selection into a strategic advantage — watch the webinar on December 1st to gain actionable insights. https://lnkd.in/ekVH5vuJ

Should sponsors provide source document templates to sites? It’s one of the most divisive questions in clinical operations — and on December 9, we’re breaking it down. Join experts from AskBio Inc., EDEE Law, Alcanza Clinical Research, and ICON plc for a fast, focused debate on the operational, legal, and regulatory implications of sponsor-provided eSource templates. Walk away with clarity on the benefits, risks, and the real compliance gray zones shaping this discussion. Register here: https://lnkd.in/eZX_-_B7

In this week's issue we'll explore: ◾ What Can We Expect From The FDA In 2026? ◾ Challenges And Opportunities For Clinical Trial Recruitment In The Digital Age ◾ How AI Is Transforming Patient Stratification ◾ Health Equity Isn't A Buzzword — It's A Business Imperative ◾ 'ONE In A MILLION' Aims To Bridge The Equity Gap In Clinical Trials and More! Abby Proch, Clinical Leader | Citeline | Daniel Gehrlach, HMNC Brain Health | Camille (Pope) Campbell, PharmD, RPh, Biogen | Maimah Karmo, Tigerlily Foundation | Jeanne M. Regnante, Patient3i | Medable, Inc | Rob DiCicco, TransCelerate BioPharma Inc. | Mural Health | Wendy Cogan | Centre for Human Drug Research

AI, open-source tools, and evolving data standards are transforming the future of biostatistics, and today’s programmers must adapt faster than ever. Explore how this shift is redefining clinical workflows, unlocking new efficiencies, and elevating the role of human expertise in a rapidly changing tech landscape. Read the full article to see what’s ahead and how to stay ahead: https://lnkd.in/eMqunhuE By Jake Gallagher, Catalyst Flex 📩 For more clinical trial insights, subscribe to the Clinical Leader e-newsletter: https://lnkd.in/etadaKdf?

The FDA is headed into 2026 under extraordinary pressure: a prolonged government shutdown, significant staffing reductions, leadership shake-ups, and looming PDUFA uncertainty. At RAPS Convergence, industry experts from The Pink Sheet, AgencyIQ, and Esham Strategies dug into what these disruptions mean for timelines, transparency, and the future stability of the agency that underpins U.S. drug development. If you’re planning submissions, preparing for regulatory shifts, or simply trying to understand how the agency may function in the year ahead, this forecast is essential context: https://lnkd.in/eSAZgpgk By Abby Proch, executive editor, Clinical Leader 📩 For more clinical trial insights, subscribe to the Clinical Leader e-newsletter: https://lnkd.in/etadaKdf?

🌐🤝 Clinical Leader Community: Shape the Future of Clinical Trials at SCOPE Summit 2026 Clinical trials are evolving fast. From decentralized models and patient-centric design to AI-driven insights and risk-based approaches, leaders need actionable strategies to keep up. SCOPE Summit 2026, February 2–5 in Orlando, FL, brings together pharma, biotech, CROs, sites, technology, and patient advocacy professionals for four days of learning, collaboration, and networking. What makes SCOPE different: • Insights you can use: Case studies, expert panels, and cross-functional discussions on today’s biggest trial challenges • Peer connections: Network with 3,500+ leaders from 1,200+ companies across 30 countries • Innovation showcase: 300+ exhibitors presenting solutions shaping the future of clinical trials • Beyond the sessions: Golf Tournament, morning Fun Run, Yoga, and networking receptions 🎟️ Clinical Leader readers can save $200 with code: CL200 👉 Register here: www.scopesummit.com SCOPE365 LTD #SCOPEsummit

“Representation doesn’t grow in spreadsheets — it grows in communities, through people.” That message sits at the core of this article and it hits a nerve in an industry that has long talked about diversity but rarely funded the work where it truly begins: at the site level. Chief Editor Dan Schell unpacks ACRO’s bold Diversity & Inclusion Site Resource Grants Program, a pilot that gives community research sites real dollars to build trust before a trial opens. One of the most compelling stories comes from Dr. Bryce Palchick, a retired family physician whose career has centered around the very communities clinical research often overlooks. His journey — from being repeatedly denied grants for early engagement efforts to finally hiring a full-time community liaison through ACRO’s program — shows what’s possible when diversity isn’t just expected, but enabled. Read the full article: https://lnkd.in/e-uEYwJp 📩 For more clinical trial insights, subscribe to the Clinical Leader e-newsletter: https://lnkd.in/etadaKdf?