In this video interview, Carole Berini, PhD, of Ontada, explains how validated proxies for variables like ECOG performance status can recover not just sample size but the representativeness of hard-to ...

Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects ...

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, explain how building trust into the data foundation—through source lineage, standardization, and reconciliation—is what makes ...

In this video interview, Carole Berini, PhD, of Ontada, explains how validated proxies for variables like ECOG performance status can recover not just sample size but the representativeness of hard-to ...

A new request for information asks for comments on dose selection, safety monitoring, eligibility criteria, and oversight ...

Real-time RBQM requires proportionate analysis frequency matched to data arrival and issue criticality, not continuous reanalysis, because signal churn from over-frequent runs creates alert fatigue ...

The FDA has published a Transparency Roadmap outlining its fiscal year 2026 milestones and fiscal year 2027 priorities across ...

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, explain how building trust into the data foundation—through source lineage, standardization, and reconciliation—is what makes ...

Mixed outsourcing models have moved from exception to mainstream as sponsors look to allocate resources more deliberately, ...

Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only ...

Autonomous capability can expand via new tools, memory, prompts, and delegation despite unchanged models, necessitating ...

In this Q&A, Claire Riches, VP of clinical solutions at Citeline, discusses how AI is transforming endpoint selection and protocol pressure-testing, what data inputs matter most for realistic ...