In today's ACT Brief, we examine CRIO and Medidata's partnership on seamless clinical trial data flow, Tufts CSDD findings on direct-to-patient site enrollment and diversity outcomes, and TransCelerate's work with FDA on selective safety data collection for pragmatic trials.
A new summary report from a joint tabletop exercise outlines how selective safety data collection approaches can be applied in practice, supporting broader adoption of pragmatic trial designs.
In this episode of the Applied Clinical Trials Podcast, Jonathan Andrus, co-CEO, CRIO, and Samir Jain, vice president of product management, healthcare data interoperability and EHR solutions, Medidata, discuss how their new partnership is enabling seamless data flow between eSource and enterprise platforms to reduce site burden and improve data quality across global clinical trials.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, moves past the buzzwords to describe what supply chain resilience means in practice, and why continuity may now deserve to sit above compliance in a sponsor's order of priorities.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, discusses why sponsors must now treat disruption as an expected condition and how real-time visibility and connected systems enable faster, more adaptive responses.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, traces how small documentation errors move through a fragmented supply chain and ultimately erode the trust that patients and regulators depend on.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, examines how siloed data and manual handoffs create version drift, visibility gaps, and failures that go undetected until the operational damage is already done.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, explains how growing trial complexity has shifted the fundamental supply chain question from efficiency to continuity, and why even small changes can cascade into trial interruptions.
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.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, identifies governance inertia and review cycle lag as the most underappreciated risks when AI speeds up protocol development faster than organizations can act on the insights it generates.
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.
In this Q&A, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, examines how clinical supply chain fragmentation has shifted from an efficiency problem into a resilience problem—and what it takes to build infrastructure capable of absorbing disruption without losing trial continuity.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, offers a measured look at where AI is genuinely accelerating upstream protocol work and why proof points of faster approvals reaching patients are still limited.
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.
The deal adds more than 200 regulatory and medical writing experts to Veristat's team, strengthening its submission capabilities across complex drug development programs.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, makes the case for integrating reimbursement probability into the standard PTRs framework earlier in development, and what happens when sponsors reach approval without a viable value story.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, discusses how crowded pipelines, compressed IP timelines, and competitive differentiation pressures are forcing smaller sponsors to treat protocol design as a core element of business strategy.
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.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, explains why the most consequential shift in clinical trial design is not methodological but organizational, and what an analysis of 200 FDA complete response letters reveals about where decisions are going wrong.
A systematic review pooling data from 17 clinical trials—including 15 involving failed or withdrawn therapies—concludes that amyloid-targeting antibodies offer little clinically meaningful benefit, prompting widespread pushback from Alzheimer's researchers.
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.
In this Q&A, Mwango Kashoki, MD, MPH, SVP and global head of regulatory strategy at Parexel, breaks down the FDA's plausible mechanism framework and what it means for sponsors developing individualized therapies in ultra-rare disease settings.
In this video interview, Del Smith, PhD, CEO and co-founder of Acclinate, outlines what a practical, sustained community engagement framework looks like in practice and how sponsors can translate that investment into faster, more efficient, and more representative enrollment.
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.
Behavioral science reveals how recruitment failures, site disengagement, and underrepresentation in clinical trials are rooted in early design decisions, and what sponsors can do to address them before they become costly problems.
In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, outlines the steps sponsors can take today—from early FDA engagement and robust non-clinical programs to adaptive trial designs and confirmatory evidence packages—to avoid delays as the guidance moves toward finalization.
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.
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 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.
In this Q&A, Jenna DiRito, PhD, COO and co-founder of Revalia Bio, discusses how earlier, human-relevant data is reshaping go/no-go decision-making in drug development and what a truly front-loaded workflow looks like in practice.
