Data Management

In this episode of the ACT Podcast, Jeneen Donadeo, executive director of portfolio management at TransCelerate, and Laura Galuchie, senior director and TransCelerate program lead at Merck, discuss the findings from a recent TransCelerate and Tufts CSDD study revealing that nearly one-third of data collected in Phase III trials is non-essential. They explore why trial complexity continues to grow despite industry efforts toward efficiency and share strategies for reducing data burden while maintaining compliance.

As decentralized and hybrid trial models expand, eConsent is emerging as a critical tool for improving participant understanding, reducing site burden, and strengthening data integrity through digital automation, accessibility, and regulatory compliance.

How a unified approach to clinical data management, powered by artificial intelligence and advanced analytics, can elevate clinical trial monitoring and redefine how teams assess, act on and learn from data.

Advancing toward more meaningful use of PRO data by making it systematic, transparent, and built into trial design.

Sustainability should be central to clinical trial design and considerate of how digital tools such as electronic clinical outcomes assessments can help achieve this.

To maximize the impact of signal detection, KRI frameworks should follow a few guiding principles.

Webinar Date/Time: Wed, Oct 22, 2025 11:30 AM EDT

In today’s high-cost R&D environment, pharma success depends less on cost-cutting and more on evidence-based portfolio decisions, niche-buster strategies, and real-world data-driven indication expansion to maximize both ROI and patient outcomes.

Pharma R&D faces rising trial complexity, high costs, and patient and investigator shortages, driving the need for adaptive models and data-driven strategies to speed therapies to market.

In an era of constant policy change, timely real-world data is emerging as pharma’s most critical tool to track patient access, anticipate shifts in treatment utilization, and improve outcomes in real time.

The full value of clinical data will only be unlocked by redesigning how it’s captured, connected, and applied to accelerate decisions, improve trials, and better serve patients.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, explains how large sample size and stratification by immunosuppressant use ensured balance and consistent efficacy assessments in the NIMBLE study.

Maximizing AI’s potential in medical writing and regulatory submissions requires data standardization, objective content practices, and a streamlined document ecosystem that accelerates timelines while ensuring compliance.

In this Q&A, Randa Wahid of Indero, and Lyn Mursalo, a freelance clinical research professional, share how sponsors and CROs can build collaborative partnerships, navigate global trial complexities, and apply practical strategies to deliver studies on time and with quality.

New guidance and technology advances are reshaping eClinical systems, positioning them as tools to accelerate enrollment, improve data quality, and reduce site and patient burden.

In this Q&A from the 2025 Veeva R&D and Quality Summit, Ibrahim Kamstrup-Akkaoui, vice president of data systems innovation at Novo Nordisk, discusses simplifying system use through the company’s DataNow program and taking a measured, stepwise approach to applying AI and automation across the clinical development lifecycle.

In this Q&A from the 2025 Veeva R&D and Quality Summit, Ibrahim Kamstrup-Akkaoui, vice president of data systems innovation at Novo Nordisk, discusses simplifying system use through the company’s DataNow program and taking a measured, stepwise approach to applying AI and automation across the clinical development lifecycle.

Strategic AI applications are helping life sciences teams overcome hidden bias, accelerate data discovery, and improve evidence integrity at the start of the pipeline.

Strategic AI applications are helping life sciences teams overcome hidden bias, accelerate data discovery, and improve evidence integrity at the start of the pipeline.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, shares practical ways clinical teams can strengthen trial protocols for expedited programs—such as incorporating control groups where possible, leveraging synthetic and real-world data, and adopting adaptive trial designs to reduce regulatory risk.

In this Q&A, Rohit Nambisan, CEO of Lokavant, and Jonathan Crowther, head of predictive analytics, Pfizer, explore how AI is transforming study feasibility, regulatory review, and trial execution.

In this episode of the Applied Clinical Trials Brief, we spotlight a recent video interview with Luke Wilson of Thermo Fisher Scientific in which he shared insights on how data visibility, remote monitoring, and integrated systems can streamline inspections, improve patient safety, and keep decentralized trials compliant and on track.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, shares key strategies for maintaining operational alignment and compliance in decentralized trials including unified data platforms, aligned SOPs, and clear governance and escalation pathways between sponsors and supply chain partners.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, outlines the key barriers to real-time oversight in clinical trials and explains how integrated systems, built-in analytics, and live dashboards can empower clinops leaders to make faster, better-informed decisions.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how integrated systems and data transparency enable sponsors to meet evolving regulatory expectations and streamline FDA inspections through enhanced operational readiness.