Textbook of Clinical Trials
Editors: David Machin, Simon Day, Sylvan Green (John Wiley & Sons, Ltd, 2004), 428 pages, hardcover, ISBN: 0471987875, £150
Steering a Trial by the Seat of Your Pants
Digital dashboards will allow you to pilot your clinical trial from the captain's chair.
Congress, Agencies Probe Conflicts of Interest
FDA and NIH investigate staff relationships with industry to eliminate any outside influence on regulatory decisions and clinical trial procedures.
Asking the Impossible of European Understanding?
To present the new scheme as a time-saver rather than a time-waster, the new guidance points out that the data required is a subset of the data required in any case for the request authorization.
Vocel's mDiary, Clinical Systems, Inc.'s ClinBook, and Provisio Inc.'s iTrials
The CDISC Operational Data Model: Ready to Roll?
Think about how you wish to use ODM across an organization, not just within a single trial. All that needs to happen is for the same identifier to be used to denote two different studies and the data for both appear to come from the same study!
2 Commerce Drive Cranbury, NJ 08512