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CTMS Promise Vs. Reality
Robert Musterer welcomes feedback about the state of CTMS or other topics. He has more than 25 years of experience in the pharmaceutical industry, including data management, programming and IS support. Author: Rob Musterer
ClinPage, December 2007
Square Pegs in Round Holes?
A curious researcher stumbles upon a cache of data on the Internet and after a quick analysis discovers a dangerous public health threat. Author: Thaddeus H. Grasela
Bio-IT World, September 2007
Meshing EDC with CTMS
The industry is turning more of its attention to Clinical Trial Management Systems (CTMS)... Author: Beth Harper
Bio-IT World, February 2007
Impact CTMS: One View from the Real World
Peer-reviewed article about CTMS with EDC.
Health-IT World, August 2006
Solutions Delivered, Not Installed
Article about software as a service might be the future of computing. Author: Paul Bleicher
Applied Clinical Trials, June 2006
Integrating the Clinical Enterprise
Leveraging technology is key to fulfilling the promise of automation and streamlining clinical trials. Author: Kate Trainor
Applied Clinical Trials, March 2006
Exclusive: FDA ‘Guidance’ on Patient Diaries Coming Soon
Article providing an introduction to FDA ‘Guidance’ on Electronic Patient Diaries. Author: Mark D. Uehling
Bio-IT World, August 2005
The CDISC Operational Data Model: Ready To Roll?
Peer-reviewed article providing an introduction to the CDISC Operational Data Model (ODM). Author: Dave Iberson-Hurst
Applied Clinical Trials, July 2004
Electronic Diaries: Source Data Out in the Open.
Peer-reviewed article dealing with the regulatory issues surrounding eSource and electronic Paper Diaries. Author: Dave Iberson-Hurst
Applied Clinical Trials, EDC Supplement, February 2004.
EDC - turning the corner?
A preer-reviewed article overseeing EDC in 2003. Author: John Hosken
InPharm, October 2003.
Investigative Site Budget Tool
Part I of article descripting a spreadsheet tool designed to help investigative sites caculate the cost of study visits. Author: Guy P. Johnson, CPA, MS
SOCRA Source, 2003.
Investigative Site Budget Tool Part II
Part II of article descripting a spreadsheet tool designed to help investigative sites caculate the cost of study visits. Author: Guy P. Johnson, CPA, MS
SOCRA Source, 2003.
ERES Complaince and Data Integrity Issues in e-Trials
Article discussing FDA's regulations concerning electronic records and electronic signature (ERES) and EREC complaince. Author: Carol A. Connell
SOCRA Source, February 2003.
Clinical Trials: The Ultimate IT Challenge
Peer-reviewed article dealing with the challenges of clinical trials informatics.
Bio-IT Word, August 2002.
Clinical Trial Data Management: Tortured by Paper
Article dealing with the challenges of clinical trials data management technologies. Author: Mark D. Uehling
Bio-IT Word, August 2002.
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