In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, discusses how heterogeneity in disease course and patient characteristics creates confounding risk when using natural history data as an external control, and what sponsors need to do to achieve meaningful patient matching.
In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, examines the biological, dosing, and population-level considerations that sponsors must get right from the start when using basket and other master protocol designs to evaluate individualized therapies across multiple conditions.
In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, breaks down how the FDA evaluates substantial evidence of effectiveness for individualized therapies in ultra-rare conditions, and why that determination depends on the totality of mechanistic, biomarker, and clinical outcome data rather than trial numbers alone.
In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, explains how the plausible mechanism framework reshapes the development timeline for individualized therapies by allowing first-in-human studies to serve as pivotal trials and giving sponsors earlier clarity on the evidence needed for approval.
In this video compilation, industry experts share their perspectives on the operational, technological, and methodological shifts defining clinical research in 2026.
In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, introduces a practical augmentation scale for thinking about how AI agents will transform clinical trial roles over the next two years and why workforce planning for that shift needs to start now.
In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, maps the highest-impact opportunities for AI across the trial lifecycle—from smarter protocol design and enrollment matching to data collection, cycle time compression, and the emerging potential of synthetic data in rare disease.
In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, argues that effective patient-centered AI must go beyond direct-to-patient tools to address social determinants of health and reduce the administrative burden on sites so that investigators can focus predominantly on the patient.
In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, outlines the leadership priorities, team structures, and boundary-spanning capabilities that separate organizations that realize meaningful AI gains from those that struggle to move beyond the pilot stage.
In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, explains how AI is being applied to case intake today and why successful adoption depends less on technology than on reimagining workflows and investing in workforce upskilling.
In this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, offers a framework for thinking about which emerging trial complexities deserve to be built into core technology platforms and which are better managed as bespoke, one-off configurations.
In this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, makes the case that intuitive, easy-to-navigate technology directly reduces errors, improves site compliance, and prevents the workarounds that quietly undermine study performance.
In this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, discusses why sponsors must integrate their digital and physical supply chains as a single operational flow and how to build the in-house capabilities and partner relationships needed to manage that complexity effectively.
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 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.
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 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 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 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 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.
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 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.
In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, explains how early-stage planning, the estimand framework, and anticipating trial conduct problems can protect data integrity and make results more convincing and actionable.
In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, reflects on the gap between sponsor expectations and statistical reality, drawing on lessons from the COVID era to argue for more pragmatic, cost-efficient trial execution and greater patient access to clinical research.
In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, examines the most common threats to trial data reliability, including opaque methodologies, synthetic controls, and the limits of AI-driven analysis, while making the case for explainable, transparent trial design.
In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, discusses how increasing trial complexity is making data interpretation less straightforward and why transparency and reproducibility are now essential.
In this video interview, David Morton, PhD, director of biostatistics at Certara, reflects on the growing role of Bayesian approaches in modern drug development, emphasizing their potential to improve decision-making, efficiency, and overall trial success.
In this video interview, David Morton, PhD, director of biostatistics at Certara, explores the practical challenges of implementing Bayesian designs, including the need for simulation, cross-functional alignment, and clear communication with regulators.
In this video interview, David Morton, PhD, director of biostatistics at Certara, outlines how increasing FDA support is helping drive adoption of Bayesian methods, particularly in rare disease and small population studies where efficiency is critical.
In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is encouraging sponsors to move beyond traditional methods, leveraging Bayesian frameworks to improve efficiency, particularly in rare disease and small population studies.
