The FDA has announced the Rare Disease Framework Initiative, a broad effort to build a new regulatory approach tailored ...

In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new ...

IgniteData and RealTime eClinical Solutions have announced a partnership that will allow research sites using RealTime's ...

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 ...

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

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 ...

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

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 ...

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

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 ...