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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
