Patients as Partners in the API Era
The availability of FHIR-based APIs enabling patients to access and use their healthcare data for multiple purposes has opened a door to an entirely new world of opportunities for partnering with patients on clinical studies.
Searching for Innovation in Research
With the term "innovation" a buzzword du jour these days, the important quest for industry is to reimagine R&D using its new capabilities to apply real-world evidence, patient engagement, and collaborative technologies.
EHR eSource: Sword of Change?
Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations-and synching EHRs with research systems.
Building on FHIR for Pharmaceutical Research
FHIR (pronounced "fire") is a new, free of cost, platform that has the ability to access and create data though EHR systems. Wayne Kubick writes that using such a platform could truly re-engineer how pharma collects data during clinical trials.
FDA, e-Source and Clinical Data – Is the Needle Moving?
CDER has thrown down the gauntlet to industry on eSource, and now has their work cut out for them on next steps.
Re-imagining Research May Need an Attitude Adjustment
We hear it all the time these days: research processes have to undergo transformative changes in order for research organizations to thrive?or even survive.
Clearing the Way for the Internet of Things
Clinical research processes need to be simplified before new technology can be properly utilized.
Personalized Medicine, Data, and Me
Is it time to realize the extraordinary promise and vision of personalized medicine?
FDA Announces Intent to Require CDISC Standards
In July 2004, FDA Commissioner Lester M. Crawford, FDA Commissioner announced the desire of the FDA to receive data in a standard format, the CDISC SDTM.
Research in the Age of Transparency
Making clinical research data more widely available creates both opportunities and risks.
Cutting Our Losses in Translation
To reduce the time from bench to bedside we need to transform competition into cooperation.
CDISC Responds to TransCelerate Questions
Research, Practice, and Learning
What will it take for healthcare data to regularly inform research?
Transformation and Translation
To really transform global research we need to agree on a common language.
Buckthorn Wars and the Essence of Clinical Data
We collect too much data, burdening investigators, monitors, and data managers.
When Worlds Collide: Healthcare and Research
Healthcare and research should pass useful information back and forth whenever possible.
Big Data, Information and Meaning
Vendors have developed systems for massive databases, but are we data ready?
The Power and Pitfalls of Aggregate Data
Public to private switch gives CROs better chance to "fix" and transform themselves.
Taking Clinical Computing in Hand
New iPad apps could allow study participants to access and record information instantly and efficiently.
Mining for Words: The Case for NLP
Natural language processing could change the way we interpret documents and data.
Memories and Musings About Models
Why models such as BRIDG are essential in developing clinical research processes and applications
When Great Ideas Meet the Real World
Promising data warehousing systems like Janus are still waiting to realize their potential.
The Semantics of Health Care Interoperability
Is computer system interoperability for clinical data an impending reality or just a dream?
Welcome to the Age of Convergence
Evolving out of disconnected technology solutions and working toward integrated processes.
EHRs, EDC, and the Hum of HIMSS
Highlights and insights from a recent gathering of thousands of health care professionals.
Observational Data Under the Microscope
Learning how such data can provide a real-world view of drug safety and effectiveness.
Applying the Supply Chain Model
Can processes used for 20 years in the manufacturing and retail industries work for us too?
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