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 ...
The FDA has published a Transparency Roadmap outlining its fiscal year 2026 milestones and fiscal year 2027 priorities across ...
Autonomous capability can expand via new tools, memory, prompts, and delegation despite unchanged models, necessitating ...
Mixed outsourcing models have moved from exception to mainstream as sponsors look to allocate resources more deliberately, ...
Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects ...
Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only ...
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 ...
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 ...
RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational ...
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 ...
In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains why combining analog trial performance ...