ACT Brief: AI Governance Lag, Site Payment Experience, and Schizophrenia Relapse Prevention
In today's ACT Brief, we examine governance inertia when AI accelerates protocol development, why payment experience is becoming a competitive differentiator for sites, and FDA approval of Caplyta for relapse prevention in schizophrenia.
2m Apr 29
2m
ACT Brief: AI Impact Faces Reality Check, Supply Chain Risks Intensify, and RWE Shapes Global Strategy
In today’s ACT Brief, we highlight where AI is delivering real gains in protocol development, how geopolitical disruption is redefining supply chain resilience, and the growing global impact of real-world evidence in drug development.
1m Apr 28
1m
ACT Brief: CRO Consolidation in Regulatory Services, Reimbursement in Development Planning, and Site Selection Misalignment
In today's ACT Brief, we examine Veristat's acquisition of Certara's regulatory business, why reimbursement probability should inform development planning earlier, and how site selection misalignment drives downstream trial performance issues.
2m Apr 27
2m
ACT Brief: Organizational Shifts in Trial Design, Amyloid Antibody Evidence Review, and Compounding's Role in Care Continuity
In today's ACT Brief, we explore organizational factors behind CRL decisions, methodological concerns with pooling amyloid antibody trial data, and how compounding addresses care gaps when commercial options fall short.
2m Apr 23
2m
ACT Brief: Community Engagement Framework for Enrollment, Plausible Mechanism Framework Essentials, and AI Scaling Foundations
In today's ACT Brief, we explore practical community engagement strategies that drive representative enrollment, how sponsors should structure development plans around the plausible mechanism framework, and the organizational prerequisites for scaling AI effectively in drug development.
2m Apr 22
2m
ACT Brief: Plausible Mechanism Pathway Implementation Steps, Behavioral Science in Trial Design, and Psychedelic Drug Accelerated Review
In today's ACT Brief, we explore practical steps sponsors can take to prepare for the plausible mechanism framework, how behavioral science addresses root causes of recruitment and diversity challenges, and FDA acceleration of psychedelic therapy reviews through executive order.
2m Apr 21
2m
ACT Brief: Natural History Data Matching Challenges, Execution Translation Gap in Trials, and Accelerated Approval Pathway Reforms
In today's ACT Brief, we explore how disease heterogeneity confounds natural history controls, the execution translation gap converting identified problems into action, and policy recommendations for strengthening FDA's accelerated approval pathway.
2m Apr 20
2m
ACT Brief: Master Protocol Design Considerations, Early Predictive Data Integration, and Real-World Evidence as Regulatory Standard
In today's ACT Brief, we explore biological and dosing considerations for basket trial designs, how human-relevant data earlier in development reduces late-stage failures, and FDA's shift toward single-trial approvals supported by real-world evidence.
2m Apr 17
2m
ACT Brief: Evaluating Evidence for Individualized Therapies, Clinical Trial Reporting Compliance, and TIL Therapy Merger
In today's ACT Brief, we explore how FDA evaluates effectiveness for ultra-rare individualized therapies, the agency's enforcement push for mandatory trial result reporting, and Obsidian's merger backed by $350 million to advance next-generation TIL cell therapy.
2m Apr 16
2m
ACT Brief: Protocol Interpretation as Startup Bottleneck, Plausible Mechanism Framework, and Real-Time Trial Tracking Systems
In today's ACT Brief, we examine how protocol interpretation and source document preparation delay study startup, how the plausible mechanism framework accelerates individualized therapy timelines, and how real-time tracking technologies improve supply chain and sample integrity in decentralized trials.
2m Apr 15
2m
ACT Brief: Real-World Data Access Expansion, eSource Implementation at Scale, and FDA Regulatory Setback for Oncolytic Therapy
In today's ACT Brief, we examine Thermo Fisher's expanded real-world data access through HealthVerity, how FHIR-based standards are finally enabling scalable eSource implementation, and FDA's second complete response letter for Replimune's oncolytic immunotherapy.
2m Apr 14
2m
ACT Brief: Clinical Trial Trends and 2026 Outlook, AI Agents and Workforce Transformation, and Degrader-Antibody Conjugate Partnership
In today's ACT Brief, we explore industry perspectives on operational and methodological shifts defining 2026, how agentic AI will augment clinical trial roles over the next two years, and Roche's expanded partnership with C4 Therapeutics on next-generation antibody conjugates.
2m Apr 13
2m
ACT Brief: Governance vs. Execution in Pharma Modernization, AI Workforce Augmentation Planning, and Adaptive Trial Regulatory Shifts
In today's ACT Brief, we examine why expanding governance layers slow digital modernization initiatives, how AI will augment clinical trial roles over the next two years, and how evolving regulatory frameworks are reshaping biopharmaceutical development timelines.
2m Apr 10
2m
ACT Brief: Diversity Built Into Trial Design, AI Impact Across Trial Lifecycle, and Companion Diagnostics Adoption
In today's ACT Brief, we explore why clinical trial diversity requires protocol redesign from the outset, the highest-impact opportunities for AI across the complete trial lifecycle, and the regulatory and operational barriers slowing companion diagnostic adoption in oncology.
2m Apr 09
2m
ACT Brief: Risk-Based Monitoring in Global Trials, Patient-Centered AI Design, and Generative AI in Healthcare
In today's ACT Brief, we examine the technical and operational challenges of implementing risk-based monitoring across global trials, how AI must address social determinants of health and site burden, and the emerging role of domain-specific generative AI in clinical practice.
2m Apr 08
2m
ACT Brief: AI Leadership and Organizational Adoption, Bayesian Methods in Drug Development, and NIH Budget Reductions
In today's ACT Brief, we explore the leadership priorities that enable meaningful AI gains in clinical research, how Bayesian methodologies are reshaping trial design and innovation, and proposed federal budget cuts threatening NIH research funding.
2m Apr 07
2m
ACT Brief: Real-World Data Across Therapeutic Areas, AI-Driven Case Intake, and COVID-19 Vaccine Trial Enrollment Challenges
In today's ACT Brief, we examine how real-world data is being applied across oncology, ophthalmology, and other therapeutic areas to optimize trial design, how AI is reshaping clinical case intake workflows, and enrollment barriers that led Pfizer and BioNTech to halt a COVID-19 vaccine trial.
2m Apr 06
2m
ACT Brief: Digital Twins for Virtual Control Arms, Clinical Tech Stack Evolution, and Universal Flu Vaccine Advances
In today's ACT Brief, we explore how digital twin technology creates reliable virtual control arms from historical data, what defines an effective clinical trial tech stack in complex studies, and emerging vaccine platforms advancing toward universal influenza protection.
2m Apr 03
2m
ACT Brief: Platform vs. Bespoke Technology, Patient and Site Experience Design, and AI-Driven ADC Development
In today's ACT Brief, we explore how to decide which trial complexities warrant core technology platforms versus custom configurations, how measuring patient and site experiences early identifies actionable solutions, and Daiichi Sankyo's collaboration with Tempus to improve ADC patient selection through AI.
1m Apr 02
1m
ACT Brief: Intuitive Technology Design and Site Compliance, Vaccine Follow-Up Strategy Optimization, and AI-Driven Antibody Discovery
In today's ACT Brief, we explore how user-friendly technology reduces errors and site workarounds, strategic approaches to combining traditional and real-world data collection for vaccine long-term follow-up, and Merck's collaboration with Infinimmune to accelerate antibody discovery using AI.
2m Apr 01
2m
ACT Brief: Clinical Technology Implementation Priorities, Digital Supply Chain Integration, and AI Drug Discovery Scale
In today's ACT Brief, we examine the three converging technology priorities reshaping trial execution in 2026, why sponsors must integrate digital and physical supply chains operationally, and Eli Lilly's multi-billion dollar AI drug discovery collaboration with Insilico.
2m Mar 31
2m
ACT Brief: Clinical Workflow User Experience, Sample Integrity and Logistics, and FDA's Unified Adverse Event System
In today's ACT Brief, we examine why eClinical platforms must prioritize user workflows over data flow, how digitizing sample tracking prevents integrity failures in transit, and the FDA's consolidated adverse event monitoring system enabling real-time safety signal detection.
2m Mar 30
2m
ACT Brief: CRO Selection as Incentive Design, Integrated Tech Stack Strategy, and Pricing Disruption in Pharma
In today's ACT Brief, we examine how game theory principles can improve CRO and vendor selection through ecosystem alignment, why clinical technology platforms must be purpose-built and fully integrated, and how pricing pressures and regulatory changes are reshaping pharmaceutical R&D investment.
2m Mar 27
2m
ACT Brief: Behavioral Science and Recruitment Design, Community Engagement in Trials, and Big Pharma's Rare Disease Interest
: In today's ACT Brief, we examine how behavioral science applied during trial design and startup can identify recruitment barriers early, the importance of authentic community engagement over traditional outreach, and how large pharmaceutical companies are increasingly investing in rare disease development.
2m Mar 26
2m
ACT Brief: Thermo Fisher Acquires Clario, Wearables and AI Integration, and Somatic Genomics for IBD
In today's ACT Brief, we examine Thermo Fisher's acquisition of Clario to expand clinical trial data infrastructure, how wearable devices and AI are reshaping patient monitoring workflows, and a collaboration between Merck and Quotient using somatic genomics to identify IBD drug targets.
2m Mar 25
2m
ACT Brief: AI and Wearables for Patient Monitoring, FDA Modernizes Evidence Standards, and Regulatory Alignment in Rare Disease
In today's ACT Brief, we explore how AI can parse wearable data streams to identify subtle clinical patterns, FDA's four major policy shifts modernizing drug development and approval standards, and ongoing questions about regulatory consistency in rare disease pathways.
2m Mar 24
2m
ACT Brief: FDA Clearance and Reimbursement for Wearables, Data Validation Across Complex Trials, and Wegovy HD Approval
In today's ACT Brief, we explore how FDA clearance and reimbursement models support wearable adoption in clinical care, the importance of end-to-end data validation before patient enrollment, and FDA approval of a higher-dose semaglutide formulation for weight loss.
2m Mar 23
2m
ACT Brief: Wearable Data Integration Challenges, Human Performance Science, and Rare Disease Regulatory Flexibility
 In today's ACT Brief, we explore the data overload and alert fatigue challenges in integrating wearable data into clinical workflows, how cognitive and behavioral science can transform site readiness and training, and FDA's evolving guidance on rare disease trial design and evidence standards.
2m Mar 20
2m
ACT Brief: Remote Monitoring and Early Intervention, NAMs Replace Animal Testing, and Glass Box Clinical Intelligence
In today's ACT Brief, we explore how continuous remote monitoring enables early clinical interventions, FDA guidance on validating new approach methodologies as alternatives to animal testing, and the importance of transparent data collection in decentralized trials.
2m Mar 19
2m
ACT Brief: Wearable Data in Clinical Care, Generalized Pairwise Comparisons, and Vaccine Policy Litigation
In today's ACT Brief, we explore how wearable data is informing real-world clinical decision-making, a statistical method that analyzes multiple patient outcomes simultaneously to improve trial design, and legal challenges to recent vaccine advisory committee changes.
2m Mar 18
2m
ACT Brief: Academic Trial Infrastructure, Vaccine Engagement Strategies, Workflow Orchestration
In today's ACT Brief, we examine the technology infrastructure gap facing investigator-initiated trials, how transparency and community engagement drive vaccine adoption, and why workflow orchestration—not just digitization—delivers operational value in clinical research.
2m Mar 17
2m
ACT Brief: Trial Transparency and Synthetic Controls, Readiness as Leading Risk Indicator, FDA Streamlines Biosimilar Pathway
In today's ACT Brief, we explore the transparency demands of complex trial designs and synthetic controls, how measuring site readiness during training predicts protocol execution, and the FDA's streamlined biosimilar development pathway aimed at reducing drug costs.
2m Mar 12
2m
ACT Brief: Trial Data Transparency, Protocol Design Drives Enrollment, FDA Shifts Approval Standards
In today's ACT Brief, we examine why transparency in complex trial designs is essential for data confidence, how protocol structure—not operational effort—determines recruitment success, and the FDA's shift toward single-trial approvals with enhanced post-market surveillance.
2m Mar 11
2m
ACT Brief: Bayesian Shifts Regulatory Culture, Quality Tolerance Limits Drive Risk Management, CBER Leadership Changes
In today's ACT Brief, we explore how Bayesian methods are reshaping FDA interactions and trial design, quality tolerance limits are becoming operational guardrails in risk-based quality management, and leadership transitions at the FDA's Center for Biologics Evaluation and Research signal evolving regulatory priorities.
2m Mar 10
2m
ACT Brief: Bayesian Implementation, Women in Statistics, and FDA Tightens Gene Therapy Standards
In today's ACT Brief, we explore the operational capabilities clinical teams need to implement Bayesian trial designs, why gender diversity strengthens data science across drug development, and the FDA's rejection of external controls for a Huntington's gene therapy candidate.
2m Mar 09
2m
ACT Brief: Bayesian Methods Drive Adaptive Trials, Digital Endpoints Gain Regulatory Footing, and FDA Cracks Down on Compounded GLP-1 Marketing
In today's ACT Brief, we explore how Bayesian approaches are powering studies in rare disease and pediatrics, a major public-private initiative is standardizing digital endpoints for regulatory acceptance, and the FDA intensifies enforcement against misleading GLP-1 marketing.
2m Mar 06
2m
ACT Brief: Bayesian Trials Advance, eSource Integration Scales, and FDA Standards Shift
In today’s ACT Brief, we highlight how Bayesian methods are reshaping adaptive trial design, a major eSource partnership is improving data flow and accuracy, and FDA approval standards continue to evolve.
2m Mar 05
2m
ACT Brief: Bayesian Approaches Expand, Patient Foundations Merge, and AI Transforms Clinical Trials
In today’s ACT Brief, we highlight how Bayesian methods are gaining operational traction, a major patient advocacy merger is streamlining clinical trial access, and machine learning is reshaping trial design through multi-modal data integration.
2m Mar 04
2m
ACT Brief: RWD Integration Accelerates, FDA Advances Ultra-Rare Therapies, and Collaboration Shapes the Next Decade
In today’s ACT Brief, we examine how the Verana Health-COTA merger is evolving real-world data use, the FDA’s new framework for individualized ultra-rare disease therapies, and what a decade of cross-industry collaboration reveals about the future of clinical development.
2m Mar 03
2m
RWD at Scale: How Verana Health and COTA Are Shaping the Future of Clinical Development
In this episode of the Applied Clinical Trials Podcast, C.K. Wang, MD, chief medical officer at COTA; and Sujay Jadhav, CEO of Verana Health, discuss how their organizations’ merger is advancing the use of real-world data to inform trial design, patient recruitment, and regulatory decision-making.
21m Mar 02
21m
ACT Brief: Bayesian Designs Gain Ground, Data Priorities Take Shape, and Rare Disease Strategy Expands
In today’s ACT Brief, we explore how Bayesian trial designs are gaining traction in rare disease research, what priorities clinical operations leaders should focus on in 2026, and how rare disease science is shaping broader drug development strategies.
2m Mar 02
2m
ACT Brief: Sites Advance AI Adoption, Cross-Functional Alignment Moves Earlier, and Phase I Strategy Evolves
In today’s ACT Brief, we explore how sites are taking the lead on AI adoption to strengthen feasibility and enrollment, why earlier cross-functional alignment is critical in data-driven trials, and how Phase I strategy is shifting toward quantitative evidence generation.
2m Feb 27
2m
ACT Brief: Data Fragmentation Risks Rise, Outsourcing Models Evolve, and FDA Pathways Face Pressure
In today’s ACT Brief, we examine how fragmented data collection continues to challenge trial quality, how hybrid outsourcing and AI are reshaping execution strategies, and why calls are growing for a risk-based FDA pathway for early-stage studies.
2m Feb 26
2m
ACT Brief: eSource Standardization Advances, Digital Protocols Gain Momentum, and Rare Disease Trial Risks Intensify
In today’s ACT Brief, we examine how protocol-driven eSource is reshaping data capture at sites, how digital protocols and data sharing are redefining trial execution, and how a Duchenne study termination highlights growing operational risks in rare disease development.
2m Feb 25
2m
ACT Brief: Site Data Quality Takes Priority, Merck Expands AI Discovery Efforts, and Gilead Advances Cell Therapy Strategy
In today’s ACT Brief, we examine how site-level data capture is becoming central to trial execution, how Merck and Mayo Clinic are scaling AI-driven discovery, and how Gilead’s latest acquisition strengthens its position in cell therapy for multiple myeloma.
2m Feb 24
2m
ACT Brief: Evinova Expands AI Partnerships, CTPM Role Evolves, and FDA Pressure Builds on GLP-1 Market
In today’s ACT Brief, we examine how Evinova is scaling AI-driven clinical development through industry collaboration, how the clinical trial project manager role is evolving amid growing complexity, and how FDA scrutiny of compounded GLP-1s could reshape market dynamics.
2m Feb 23
2m
ACT Brief: SCOPE Highlights Operational Discipline, AI Adoption Accelerates Execution, and FDA Rethinks Evidence Standards
In today’s ACT Brief, we examine how SCOPE 2026 reinforced the link between speed and strategy, how AI adoption is driving real-world efficiency gains, and how FDA’s evolving evidence standards could reshape approval pathways.
2m Feb 20
2m
ACT 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 how FDA review of an mRNA flu vaccine candidate is back on track.
2m Feb 19
2m
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 pragmatic trials, and how leadership restructuring at HHS may shape health policy execution.
2m Feb 18
2m
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 integrate digital measurement tools, and how global competition and data-driven site selection are reshaping clinical trial activity.
2m Feb 17
2m