Shows / Applied Clinical Trials
Episodes
Applied Clinical TrialsACT Brief: Predictive Analytics Advance, Collaborative Data Standards Scale, and Moderna’s Flu Vaccine Review Moves Forward
In today’s ACT Brief, we examine how predictive analytics are shaping portfolio decisions, how industry collaboration is scaling digital data standards, and…
- Applied Clinical Trials
ACT Brief: AI Enables Real-Time Trial Oversight, Provider Engagement Strengthens Recruitment, and HHS Leadership Restructures Operations
In today’s ACT Brief, we examine how AI is enabling continuous trial monitoring and faster site decisions, how provider participation influences recruitment in…
- Applied Clinical Trials
ACT Brief: AI Moves Into Implementation, Digital Measurement Adoption Accelerates, and Global Trial Competition Intensifies
In today’s ACT Brief, we examine how AI is shifting from pilot programs into daily development workflows, how a new adoption platform is helping sponsors…
- Applied Clinical Trials
ACT Brief: eSource Moves Toward AI-Enabled Validation, Outsourcing Models Shift Toward Flexibility, and Robust Trial Design Becomes Mission Critical
In today’s ACT Brief, we explore how eSource adoption is advancing with AI-enabled validation and interoperability, examine how flexible outsourcing models are…
- Applied Clinical Trials
ACT Brief: Regional Risk Variability Emerges, Patient Experience Drives Retention, and Digital Endpoints Scale in Oncology
In today’s ACT Brief, we examine new data on regional variation in clinical trial risk, why patient experience must move from intent to execution, and how…
- Applied Clinical Trials
ACT Brief: Real-World Data Connectivity Expands, AI Supports Smarter Data Capture, and Diversity Strategies Refocus at SCOPE
In today’s ACT Brief, we cover a new real-world data collaboration aimed at scalable interoperability, how AI fits into modern data capture and quality…
- Applied Clinical Trials
ACT Brief: AI Scales Trial Design, ESG Becomes a Readiness Test, and Sites Push Back on Payment Practices
In today’s ACT Brief, we cover how AI is being deployed to optimize global trial design, why ESG performance is emerging as a core vendor qualification signal…
- Applied Clinical Trials
ACT Brief: Purpose Meets Operational Focus, Acceleration Shifts Upstream, and AI Delivers Near-Term Impact
In today’s ACT Brief, we highlight how purpose-driven efficiency is reshaping clinical development priorities, where leaders see the greatest opportunity for…
- Applied Clinical Trials
ACT Brief: FDA Capacity Strains Timelines, Sponsors Rethink Site Support, and Regulators Align on AI
In today’s ACT Brief, we examine how reduced FDA capacity is extending regulatory timelines, why sponsors are rethinking operating models to reduce site burden…
- Applied Clinical Trials
ACT Brief: RWE Refines Trial Design, Oncology CRO Scale Expands, and Feasibility Pressures Persist
In today’s ACT Brief, we look at how real-world evidence is reshaping trial design rather than replacing trials, what Worldwide Clinical Trials’ acquisition of…
- Applied Clinical Trials
ACT Brief: ESG Moves Into Vendor Oversight, RWE Faces Governance Hurdles, and Roche Advances Obesity Pipeline
In today’s ACT Brief, we examine why ESG efforts in clinical development are shifting into vendor oversight, what data and governance barriers still limit…
- Applied Clinical Trials
ACT Brief: Decentralized Innovation Faces Reality, RWE Finds Its Lane, and Clinical Ops Reset for 2026
In today’s ACT Brief, we explore why decentralized trial innovations struggle to scale without better change management, where real-world evidence most…
- Applied Clinical Trials
ACT Brief: De-Identified Data Expands Trial Design, Global Production Normalizes, and FDA Updates Quality Framework
In today’s ACT Brief, we examine how large de-identified datasets are reshaping trial design and site strategy, why global pharmaceutical production is…
- Applied Clinical Trials
ACT Brief: De-Identified RWE Gains Ground, HHS Funding Stabilizes Research, and U.S. Finalizes WHO Exit
In today’s ACT Brief, we look at how FDA policy is accelerating the use of de-identified real-world evidence in clinical development, why a new bipartisan…
- Applied Clinical Trials
ACT Brief: Global Trials Scale Up, Site-Centric Startup Gains Focus, and Pfizer Expands Vaccine Partnerships
In today’s ACT Brief, we look at how global clinical development is evolving through decentralized models and emerging markets, why site-centric practices are…
- Applied Clinical Trials
ACT Brief: Life Sciences Hold the Line on DEI, Startup Timelines Stretch Further, and Regulators Align on AI Governance
In today’s ACT Brief, we examine why life sciences companies are maintaining DEI commitments amid political pressure, what’s driving longer site activation…
- Applied Clinical Trials
ACT Brief: Signal Durability Redefines RBQM, AI Targets Startup Friction, and CDMOs Advance Patient-Centric Formulation
In today’s ACT Brief, we look at why durable signal closure is emerging as a defining metric in risk-based quality management, how AI can reduce startup delays…
- Applied Clinical Trials
ACT Brief: Closing Gender Gaps in Parkinson’s Research, Startup Communication Breakdowns, and a New White House Healthcare Plan
In today’s ACT Brief, we look at efforts to address sex-based evidence gaps in Parkinson’s disease research, why communication failures continue to delay study…
- Applied Clinical Trials
ACT Brief: AI Extends Trial Registries, Contract Bottlenecks Delay Activation, and Data Integration Pushes Integrated Care
In today’s ACT Brief, we look at how AI is reshaping clinical trial registries into discovery tools, why contract and budget negotiations remain the biggest…
- Applied Clinical Trials
ACT Brief: Moving Beyond AI Pilots, FDA Advances Bayesian Trials, and Sites Strained by Trial Design
In today’s ACT Brief, we examine what will separate sponsors that scale AI beyond pilots in 2026, break down the FDA’s new draft guidance on Bayesian…
- Applied Clinical Trials
ACT Brief: Community Sites Prove Readiness, Platformization Reshapes Clinical Ops, and AI Targets Precision Care at JPM
In today’s ACT Brief, we look at how community research sites can stay competitive under efficiency pressure, why 2026 is shaping up as a turning point for…
- Applied Clinical Trials
ACT Brief: Community Sites Compete on Readiness, COA Licensing Bottlenecks Slow Start-Up, and AI’s Foundations in Pharmacovigilance
In today’s ACT Brief, we examine how community research sites can stay competitive under rising efficiency pressures, why clinical outcome assessment licensing…
- Applied Clinical Trials
ACT Brief: Trial Competition Slows AI Gains, Rethinking Patient-Level Safety Decisions, and What Separates Real AI Platforms in Clinical Trials
In today’s ACT Brief, we look at how growing trial competition is undermining AI-driven efficiency gains, why pharmacovigilance is shifting toward…
- Applied Clinical Trials
ACT Brief: Recalibrating Trial Efficiency and Access, Verana-COTA Merge to Expand RWE Scale, and FDA Rejects Hetlioz Jet Lag Indication
In today’s ACT Brief, we hear how sponsors may redefine efficiency to protect patient access in 2026, review Verana Health’s merger with COTA to expand…
- Applied Clinical Trials
ACT Brief: EU Comparator Drug Sourcing Pressures, AI Expands Its Role in Oncology Trials, and Rethinking AI Value in Clinical Development
In today’s ACT Brief, we examine the growing challenges of sourcing comparator drugs across the EU, highlight a new AI-driven oncology collaboration between…
- Applied Clinical Trials
ACT Brief: Rethinking Representation in Cancer Trials, Positive Phase IIb SLE Data, and a Major Obesity Drug Partnership
In today’s ACT Brief, we examine why representative enrollment remains a barrier in US cancer trials, review Johnson & Johnson’s positive Phase IIb results for…
- Applied Clinical Trials
ACT Brief: Reframing Site Initiation Readiness, Operational Execution as Competitive Advantage, and a Historic Motion Sickness Approval
In today’s ACT Brief, we explore how site initiation can be leveraged to improve early trial performance through demonstrated readiness, examine how AI and…
- Applied Clinical Trials
ACT Brief: Persistent Barriers to Cancer Trial Participation, Clarifying IRT Data Ownership, and Clinical Trial Opportunities in Sub-Saharan Africa
In today’s ACT Brief, we examine persistent barriers limiting cancer trial participation and emerging approaches to address them, outline new guidance…
- Applied Clinical Trials
ACT Brief: Support Services and Cancer Trial Access, 2025’s Most-Watched ACT Video Interviews, and FDA Approval of Narsoplimab
In today’s ACT Brief, we examine new data from the American Cancer Society on how transportation and lodging support affect cancer trial participation, review…
- Applied Clinical Trials
ACT Brief: FDA Approval of Oral Wegovy, 2025’s Most-Read ACT Coverage, and Data Quality as the Foundation for AI
In today’s ACT Brief, we cover the FDA approval of oral Wegovy based on Phase III OASIS 4 results, recap the most-read Applied Clinical Trials articles of…
- Applied Clinical Trials
ACT Brief: AI-Enabled Workflow Automation, Subcutaneous Lunsumio VELO Approval, and Pan-KRAS Early-Stage Development
In today’s ACT Brief, we look at how AI-enabled workflows can automate existing site processes, review the FDA approval of subcutaneous Lunsumio VELO for…
- Applied Clinical Trials
ACT Brief: Building a Digital Thread in Life Sciences, CRO Sourcing Decisions and Site Burden, and Lilly’s Oral GLP-1 Phase III Results
In today’s ACT Brief, we examine why fragmented data systems continue to slow life sciences research, review how sponsor sourcing decisions may affect site…
- Applied Clinical Trials
ACT Brief: Neutral Tech Adoption at Sites, Scaling Unstructured Data for eSource, and Novo Nordisk’s CagriSema NDA
In today’s ACT Brief, we examine how sponsors are reassessing new engagement technologies to avoid increasing site burden, review new research on integrating…
- Applied Clinical Trials
ACT Brief: Rethinking Site Support in 2026, GSK’s New Severe Asthma Approval, and Priority Review Momentum in Multiple Myeloma
In today’s ACT Brief, we look at emerging operational changes aimed at reducing site burden, review the FDA approval of GSK’s twice-yearly biologic for severe…
- Applied Clinical Trials
ACT Brief: Patient Preferences in Remote Trials, Sanofi’s Neurology and Immunology Deals, and AI-Driven Biomarkers in Oncology
In today’s ACT Brief, we examine new survey data revealing what patients value most in remote clinical trials, break down Sanofi’s latest partnerships aimed at…
- Applied Clinical Trials
ACT Brief: AI-Enabled End-to-End Trials, New Phase III Data in HIV, and a First-Line Shift in HER2-Positive Breast Cancer
In today’s ACT Brief, we close out our McKinsey interview series with a look at how AI could transform clinical trials end to end, review new Phase III data…
- Applied Clinical Trials
ACT Brief: Training Community Oncology Sites, Digital Tools for Patient-Centric Trials, and New Phase III Momentum in Obesity R&D
In today’s ACT Brief, we look at new evidence showing how targeted training can build research readiness at community cancer centers, explore McKinsey’s view…
- Applied Clinical Trials
ACT Brief: AI-Enabled COA Migration, Expanding Trial Footprints into Routine Care, and New FDA Approval in Myasthenia Gravis
In today’s ACT Brief, we examine new data on how AI is improving the accuracy and speed of COA localization, break down McKinsey’s perspective on why trials…
- Applied Clinical Trials
ACT Brief: AI’s Impact on Trial Timelines, New Strategies in Obesity R&D, and Why Patient Support Needs a Clinical Backbone
In today’s ACT Brief, we highlight new insights from McKinsey on where AI can meaningfully accelerate clinical development, break down the emerging design and…
- Applied Clinical Trials
ACT Brief: New CAR-T Trial Requirements, Pfizer Advances Oral GLP-1 Strategy, and Kisqali Shows Durable Long-Term Control
In today’s ACT Brief, we break down FDA’s new superiority requirement reshaping CAR-T development, examine Pfizer’s global move into oral small-molecule GLP-1…
- Applied Clinical Trials
ACT Brief: Governance-Driven eCOA Acceleration, Site Operations Innovation, and New Momentum for Earlier CAR-T
In today’s ACT Brief, we explore how stronger vendor–sponsor governance is speeding eCOA study startup, hear from AMR Clinical on the biggest opportunities to…
- Applied Clinical Trials
ACT Brief: AI-Driven Repurposing Advances, GCP Adoption Challenges, and New CAR-T Milestone
In today’s ACT Brief, we look at how AI and in-silico methods are reshaping drug repurposing, why staggered ICH GCP rollouts are creating new operational…
- Applied Clinical Trials
ACT Brief: CNS Trial Expansion, Vaccine Policy Debate, and New Leadership at FDA
In today’s ACT Brief, we look at what’s fueling rapid growth in CNS and autoimmune research, why former FDA leaders are warning that new vaccine policies could…
- Applied Clinical Trials
ACT Brief: Targeted Trial Growth, Site Startup Strains, and Leadership Shake-Up at FDA
In today’s ACT Brief, we look at new insights on strategy-driven clinical development, fresh survey data revealing persistent site startup delays, and major…
- Applied Clinical Trials
ACT Brief: FDA’s Agentic AI Rollout, Exercise Interventions for Long COVID, and Patient-Centered Evidence Beyond the Trial
In today’s ACT Brief, we look at the FDA’s deployment of an agency-wide agentic AI platform, review new data showing how structured exercise programs can…
- Applied Clinical Trials
ACT Brief: Ultra-Compressed CNPV Review Timelines, New IgAN Therapy Approval, and Smarter Clinical Reference Data Strategies
In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission readiness, review the FDA’s…
- Applied Clinical Trials
ACT Brief: The Evolving CRA Role, New Immunotherapy Standard in Gastric Cancer, and Priority Review for Higher-Dose Wegovy
In today’s ACT Brief, we examine how the CRA role is transforming alongside modern clinical trial technology, review the FDA’s approval of Imfinzi plus FLOT as…
- Applied Clinical Trials
ACT Brief: AI in Clinical Research, FDA Gene Therapy Approval, and High-Performing Hospital Partnerships
In today’s ACT Brief, we examine how AI is being integrated into administrative workflows at investigative sites, highlight the FDA’s approval of the first…
- Applied Clinical Trials
ACT Brief: AI-Driven Pharmacovigilance, Site-Led Digital Investments, and Smarter Multi-Touch Recruitment
In today’s ACT Brief, we examine how AI and functional service partners are reshaping global pharmacovigilance, look at new data on how investigative sites are…
- Applied Clinical Trials
ACT Brief: Digital Recruitment Strategies, Tremfya’s Long-Term PsA Results, and Agentic AI’s Enterprise Impact
In today’s ACT Brief, we look at how Trialbee evaluates nontraditional digital platforms for patient recruitment, review new 48-week data from J&J’s APEX trial…
- Applied Clinical Trials
ACT Brief: Smarter Study Planning, New AML Approval, and Biomarker Gaps in Cancer Care
In today’s ACT Brief, we look at how real-world data and AI are helping prevent costly study rescue, review the FDA’s approval of a first-in-class menin…
- Applied Clinical Trials
ACT Brief: Site Satisfaction, eSource Data Transfers, and Gilead HIV Trial Results
In today’s ACT Brief, we examine declining site satisfaction and strategies to improve sponsor-site collaboration, review a new partnership enabling automated…
Applied Clinical TrialsImproving Site Satisfaction Through Better Technology and Collaboration
Melissa Hutchens, vice president of research & benchmarking at WCG, and Jimmy Garza, senior director of clinical operations at Bayer, discuss findings from the…
- Applied Clinical Trials
ACT Brief: AI Decision-Making, Sponsor Oversight Trends, and HHS Label Changes
In today’s ACT Brief, we look at how artificial intelligence is reshaping drug development decisions across pharma, discuss evolving sponsor oversight in site…
- Applied Clinical Trials
ACT Brief: Adaptive Trial Designs, Wegovy’s MASH Breakthrough, and Lilly’s Expanding Partnerships
In today’s ACT Brief, we look at how adaptive trial models are reshaping precision medicine, new data showing Wegovy’s impact on liver health, and Eli Lilly’s…
- Applied Clinical Trials
ACT Brief: AI, Caplyta Approval, and FDA Priority Vouchers
In today’s ACT Brief, we explore how AI and tokenized data are improving patient-protocol matching, highlight Caplyta’s new FDA approval for major depressive…
- Applied Clinical Trials
ACT Brief: Designing Feasible Protocols and Breakthroughs in Obesity and Metabolic Research
In today’s ACT Brief, we explore how real-world data can improve protocol design and feasibility, highlight new findings from Novo Nordisk’s oral semaglutide…
- Applied Clinical Trials
ACT Brief: Data Strategy, AI Integration, and Rare Disease Milestones Drive Clinical Innovation
In today’s ACT Brief, we highlight new insights on recruitment bottlenecks from Citeline’s Matt Holms, UCB’s first-in-class approval for TK2 deficiency, and…
- Applied Clinical Trials
ACT Brief: Tech-Driven Data Strategies and Long-Term Vaccine Success
In today’s ACT Brief, we highlight new insights from TransCelerate on streamlining clinical data to reduce burden, explore how Phastar is using technology to…
Applied Clinical TrialsStreamlining Clinical Data to Reduce Site and Participant Burden
In this episode of the ACT Podcast, Jeneen Donadeo, executive director of portfolio management at TransCelerate, and Laura Galuchie, senior director and…