In today’s ACT Brief, we examine what it will take to scale EHR-to-EDC connections for real-time trials, how the FDA is reimagining rare disease drug development, and why oncology real-world evidence still faces persistent data barriers.
|Articles|July 21, 2015
PAREXEL Launches Next Generation Analytics
With the Perceptive MyTrials Analytics solution, clinical trial sponsors can now use a mobile-enabled, single entry-point to access predictive data analytics.
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PAREXEL, a global biopharmaceutical services provider, launched the next generation of its Perceptive MyTrials® platform with advanced analytics capabilities. With the Perceptive MyTrials Analytics solution, clinical trial sponsors can now use a mobile-enabled, single entry-point to access predictive data analytics for multiple studies simultaneously. The solution offers real-time and aggregated analytics allowing sponsors and PAREXEL® clinical research professionals to detect key signals and trends.
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A new white paper and public engagement process outline the FDA’s commitment to building fit-for-purpose evidentiary standards, stronger patient voice integration, and greater regulatory predictability across rare disease drug development and review.
Real-time clinical trials require standardized digital data capture at the point of care through scaled eSource-EDC-EHR integration, but progress stalls because competing standards lack regulatory enforcement and one-off system integrations cannot scale beyond single studies without industry-wide alignment and legal clarity on data ownership.
In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new partnerships automate data transfer from site systems to sponsor platforms, and how Roche is licensing a novel obesity target from a biotech pioneer.
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In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, identify three persistent obstacles to consistent real-world evidence generation in oncology—inconsistent data capture, structural data limitations that modeling alone can't fix, and the need for earned generalizability through deliberate multi-site validation.
How a phased CRO partnership built on ICH E6(R2) and E6(R3) principles supported a multi-indication biotech portfolio.
The second of a two-part perspective examining why clinical trial enrollment and representation outcomes are shaped long before the first patient is screened.
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