Wayne Kubick

Articles

Patients as Partners in the API Era

December 01, 2018

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

February 01, 2017

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?

June 01, 2016

Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations-and synching EHRs with research systems.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

May 05, 2016

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?

October 21, 2015

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

November 03, 2014

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.

FDA Announces Intent to Require CDISC Standards

September 24, 2013

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.