invivodata: FDA’s New PRO Guidance Highlights Patient’s Perspective

May 17 | eCliniqua | Evidence is mounting that the Food and Drug Administration (FDA) wants to hear the voice of the patient in clinical trials. "They want to make sure PRO data are collected in a reliable way so they can make reasonable judgments based on those data,” says Doug Engfer, president and CEO of invivodata.

The Reality of Medical Software Compliance

Jan 19 | Expert Commentary | “It is estimated that 60% of the computer systems containing patient medical records currently in use within the United States are not in compliance with the industry standards for security, audit trails, and electronic signatures,” states industry expert David Nettleton, FDA Compliance Specialist, of Computer System Validation.

Adverse Event Reporting Begins at Clinicaltrials.gov

Sep 21 | Starting on September 27, sponsors of industry-, academic- and government-run clinical trials will have to begin reporting adverse events on www.clinicaltrials.gov.

Will Regulated Product Submission (RPS) Trump eCTD?

June 26, 2009 | Just as the electronic common technical document (eCTD) is gaining traction as the required format for electronic regulatory submissions, the FDA is changing the game.  

Workgroup Sets Priorities to Harmonize Standards for EHRs and Research

eCliniqua | The much anticipated convergence of data between clinical trials and electronic health records (EHR) is heading toward reality with the recent formation of the EHR Clinical Research Value Case Workgroup.