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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.
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Harnessing (and Securing) Meaningful Health Data
May 3 | eCliniqua | “There isn’t going to be some massive database in the basement of the White House run by Sarah Palin,” promised John Halamka, the CIO of Harvard Medical School, in his keynote at the Bio-IT World Expo.
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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.
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Peddicord: New Privacy Concerns with ‘HIPAA 2’
Jan 4 | eCliniqua | A new set of federal privacy and security requirements, introduced by legislation promoting the adoption of electronic health records (EHRs), “may make the investigator-CRO interface more complicated for some time.”
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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.
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BioClinica Acquires Tourtellotte Solutions
Sep 21 | BioClinica has acquired Tourtellotte Solutions, best known for its supply chain simulation and interactive voice (IVR)/interactive web (IWR) software.
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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.
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Phase Forward Helps FDA, DoD Monitor Drug Safety
eCliniqua | The Department of Defense last year chose Phase Forward’s Lincoln Safety Group to support a new drug safety initiative, enabling it to provide the FDA with rapid assessment capabilities.
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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.
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Etrials Purchase Would Make BioClinica Number Three EDC Player
May 8, 2009 | What reputable products and a succession of management teams couldn’t do for etrials Worldwide its soon to be owner most likely can boost stagnating sales and stem the red ink.
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