Wayne Kubick

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.

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.

Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations-and synching EHRs with research systems.

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.

CDER has thrown down the gauntlet to industry on eSource, and now has their work cut out for them on next steps.

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.

Clinical research processes need to be simplified before new technology can be properly utilized.

Is it time to realize the extraordinary promise and vision of personalized medicine?

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.

Making clinical research data more widely available creates both opportunities and risks.

To reduce the time from bench to bedside we need to transform competition into cooperation.

What will it take for healthcare data to regularly inform research?

To really transform global research we need to agree on a common language.

We collect too much data, burdening investigators, monitors, and data managers.

Healthcare and research should pass useful information back and forth whenever possible.

Vendors have developed systems for massive databases, but are we data ready?

Public to private switch gives CROs better chance to "fix" and transform themselves.

New iPad apps could allow study participants to access and record information instantly and efficiently.

Natural language processing could change the way we interpret documents and data.

Why models such as BRIDG are essential in developing clinical research processes and applications

Promising data warehousing systems like Janus are still waiting to realize their potential.

Is computer system interoperability for clinical data an impending reality or just a dream?

Evolving out of disconnected technology solutions and working toward integrated processes.

Highlights and insights from a recent gathering of thousands of health care professionals.

Learning how such data can provide a real-world view of drug safety and effectiveness.

Can processes used for 20 years in the manufacturing and retail industries work for us too?