Data Management

Clinical data security built into system architecture from the foundation, rather than layered on afterward, reduces regulatory risk and actually accelerates research by removing manual compliance burden and improving team confidence in data integrity.

In this Q&A, Raj Indupuri, CEO and co-founder of eClinical Solutions, discusses what the FDA's push toward continuous data review actually demands of sponsors operationally, why fragmented systems are the core obstacle, and how AI and real-world evidence fit into a more data-driven regulatory environment.

From real-time evidence generation to federated AI to site-level data integration, ACT spoke with seven experts at DIA 2026 on the trends and challenges defining clinical trial operations today.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, explains why organizations that build infrastructure capable of harmonizing clinical and real-world data in real time will be best positioned for the continuous, data-driven regulatory environment now emerging.

A Tufts CSDD study quantifies risk-based quality management's net financial value at $13.8 million per Phase III oncology trial, with ROI multiples up to 22.7x driven primarily by cycle time reductions rather than monitoring cost savings.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, argues that study-by-study RBM is no longer sufficient and describes what enterprise-wide, AI-enabled risk and quality management looks like in practice.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, makes the case that governance and quality must be built into every stage of the trial life cycle—not enforced at database lock or submission—and what that requires from teams and technology.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, explains why the FDA's push toward continuous data review exposes the fragmentation at the heart of current clinical trial infrastructure and what unified data pipelines need to look like to make it possible.

From planning one Phase III trial at a time to digital standardization on repeat.

Patient Engagement Strategies in Anti-Obesity Medication Clinical Trials: Addressing Drop Out Rate and Improving Retention

In this Q&A, Sam Hinsley, statistics manager at Phastar, discusses the role statisticians play in raising standards across the clinical development timeline—and why getting early phase decisions right is critical to the entire drug development pathway.

In this video interview, Liz Beatty, co-founder and chief strategy officer at Inato, explains how AI is replacing unreliable feasibility estimates with precise, real-time patient matching—and what that means for reducing non-enrolling sites and screen failure rates.

Optimization challenges spurring cultural, strategic, and organizational change.

As the FDA formally recognizes real-world evidence as eligible confirmatory evidence for drug approval, sponsors face a growing imperative to build the data infrastructure, organizational alignment, and analytical capabilities needed to use RWE effectively across the development lifecycle.

Real-world evidence is shifting from a post-market footnote to a concurrent validation layer running alongside trial data, requiring organizations to build unified data environments that integrate EHRs, claims, and patient-reported outcomes on an ongoing basis rather than retrospectively.

Despite clear data quality and regulatory advantages, paper-based clinical outcome assessments persist due to cost asymmetry, trial complexity, startup timelines, and provider capability gaps, though hidden paper costs and loss of institutional knowledge often outweigh upfront electronic implementation expenses.

In this video interview, Sam Hinsley, statistics manager at Phastar, explains why early phase decisions are the foundation of the entire development pathway and what is at stake statistically when those decisions are made on limited data.

In this video interview, Sam Hinsley, statistics manager at Phastar, makes the case that as trial designs grow more complex, collaboration between statisticians and clinical experts is not just helpful but necessary to get meaningful answers.

Clinical Trials Day is an international celebration of everyone who makes medical discoveries possible. It is also an opportunity to shine a light on the innovations helping to keep research rising.

In this video interview, Sam Hinsley, statistics manager at Phastar, explains how statisticians can ensure patient data is used responsibly and innovatively across every phase of development, from rare disease to personalized medicine to AI.

Webinar Date/Time: Thursday, June 11th, 2026 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST

Clinical development productivity improved in 2025, but gains remain fragile as end-to-end timelines lengthened again, signaling that future success depends less on individual trial execution and more on program-level orchestration, site engagement, and adaptive operating models.

Webinar Date/Time: Thursday, June 4th, 2026 at 11am EDT|8am PDT|4pm BST|5pm CEST