Wayne Kubick


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Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations-and synching EHRs with research systems.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