Data Management

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.

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.

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

Pediatric trial participation shapes children's and caregivers' long-term psychological outcomes, yet protocol design often overlooks experience as a variable affecting recruitment, retention, and data integrity—a gap increasingly recognized by regulators and quality standards

As imaging-heavy clinical trials grow more complex and globally distributed, sponsors are increasingly re-evaluating traditional infrastructure models, with cloud-native platforms showing potential to reduce operational burden, accelerate site activation, improve imaging quality oversight, and lower total trial costs.

From payment delays and feasibility misalignment to technology burden and AI adoption, clinical research sites are navigating a convergence of pressures that increasingly determine who sponsors work with and how well trials perform.

Early integration of clinical, operational, and patient-level insights during trial development can help close the gap between evidence generation and commercial performance, improving alignment between product value and real-world adoption.

When using electronic clinical outcome assessments (eCOA), ensuring clear stakeholder alignment throughout the lifecycle of a study regarding data management activities is critical to success.

Integrating technology and collaboration to close the evidence gap.

The execution translation gap—the failure to convert identified problems into coordinated, timely action—costs millions per trial through delayed amendments, persistent deviations, and slow site activation, yet remains addressable through aligned accountability and proactive execution management.

Webinar Date/Time: Tue, May 12, 2026 11:00 AM EDT

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.

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.

A collaborative study by the Tufts Center for the Study of Drug Development and CRIO identifies protocol interpretation and source document preparation as an understudied yet significant bottleneck in study start-up timelines that may hold key opportunities for efficiency gains.

Pharma modernization initiatives stall not from lack of ambition but from expanding governance layers that distance leadership from execution, slowing decision velocity and delaying the systems integration that drives competitive advantage.

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.

Webinar Date/Time: Thu, May 7, 2026 1:00 PM EDT

Webinar Date/Time: Thursday, April 30th, 2026 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Real-world data is increasingly used to optimize trial design, reduce recruitment burden, and support regulatory decisions, but adoption remains uneven due to challenges around data quality, integration, and internal alignment across functional areas.

In this Q&A, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, examines what it takes to build and sustain a clinical trial technology infrastructure that can keep pace with increasingly complex study designs.