News

In this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, examines why current eClinical technology too often prioritizes data flow over the day-to-day needs of users and what a truly guided workflow experience should look like for busy site teams.

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 this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, explains why an effective tech stack must be purpose built, fully integrated, and designed above all to simplify the execution of clinical research.

Moving beyond vendor evaluation to incentive design in Phase II/III rare and genetic disease trials.

: 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 this video interview, Del Smith, PhD, CEO and co-founder of Acclinate, examines the structural and relational barriers that keep underrepresented communities out of clinical trials and explains how authentic, sustained community engagement differs from traditional recruitment outreach.

In part 1 of this three-part series, behavioral science reveals how slow patient recruitment and enrollment challenges often stem from design and startup decisions made long before recruitment begins, but can be identified and resolved early when they still matter.

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.

Deal adds endpoint data collection and management platform to Thermo Fisher's clinical research portfolio, with Clario's technology having supported the majority of FDA and EMA novel drug approvals over the past decade.

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 the first months of 2026, the FDA has moved on multiple fronts to modernize how drugs are developed, evaluated, and approved, signaling a broader regulatory shift toward flexibility, mechanism-based evidence, and human-centric science.

In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, explores how AI models capable of analyzing continuous wearable data streams alongside broader patient information could detect subtle warning signs of deterioration that no clinician could identify alone.

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.

Why rigorous testing and validation matter more than ever.

In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, discusses how regulatory trust-building and reimbursement reform are essential to making wearable devices a sustainable and widely adopted part of clinical care delivery.

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.

Brian S. McGowan, PhD, chief learning officer at ArcheMedX, explores how aligning the science of thinking, learning, and doing can reduce deviations, enhance performance, and accelerate trial success.

In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, examines the operational challenges of incorporating wearable data into clinical workflows, including information overload and false alarm fatigue, and what those obstacles mean for patient safety.

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 this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, explains how continuous remote monitoring enables earlier detection of patient deterioration and allows care teams to intervene before conditions escalate to hospitalization.

New framework establishes scientific standards for alternative methodologies, signaling a regulatory shift toward human-centric data in preclinical drug development.

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 this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, discusses how wearable devices are giving clinicians a unique window into patient health outside the clinic and why that real-world visibility is becoming essential to modern care.

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.

Investigator-initiated trials operate under the same regulatory and operational requirements as industry-sponsored studies but rely on fragmented, consumer-grade tools, creating a persistent technology gap that can impact data integrity, efficiency, and compliance.

Analysis from the Tufts Center for the Study of Drug Development suggests that transparency in clinical evidence, community engagement, and more representative clinical trials are key factors associated with faster vaccine adoption and improved public trust.

In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, makes the case for generalized pairwise comparisons and the win ratio as transformative approaches to trial analysis that incorporate multiple outcomes simultaneously and better reflect what matters most to patients.

The next phase of digital transformation in clinical research will not be defined by the number of platforms deployed, but by how well those platforms work together in service of participants, sites, and science.