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 22, 2015
Medidata and Validic Collaborate to Expand mHealth Ecosystem
Collaboration Enables Use of Actionable, Patient-Generated Data in Clinical Trials from Extensive Range of mHealth Sensors, Wearables and Apps
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Medidata
a global provider of cloud-based solutions for clinical research in life sciences, and
Validic
, a digital health platform, announced a collaboration to expand access to patient-generated data from a broad range of consumer and medical grade mobile health (mHealth) devices and apps. The collaboration increases the extent of which mHealth tools that can be used to support clinical research, giving trial sponsors greater flexibility to select sensors, wearables and apps based on specific study endpoints and patient needs.
Read the full release here.
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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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