The second of a two-part perspective examining why clinical trial enrollment and representation outcomes are shaped long ...

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, describe what operationalizing regulatory-grade ...

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

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 ...

In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the ...

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 ...

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, ...

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

RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational ...

In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains why combining analog trial performance ...