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© 2022 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2022 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
Applied Clinical Trials
October 01, 2010
Pharmacists and patient groups welcome the new European Union directive on pharmacovigilance.
Updates on the pian drugs market.
Collecting too many metrics can lead to misappropriation and misinterpretation.
Industry news focusing on the people and organizations who work in the clinical trials profession.
View from Brussels
Routine inspections and regulations can help maintain GCP standards in global trials.
View from Washington
Reform law requires tracking and disclosure of fees to investigators and research consultants.
Access to all available medical evidence can profoundly improve treatment effectiveness.
Clinical grant expenditures represent a major portion of the budget for later phase clinical trials.
Waiving inclusion/exclusion criteria affects investigators, subjects, sponsors, and the trial itself.
A Closing Thought
The act creates serious concerns about the industry's ability to recruit and retain well-qualified investigators.
Knowing when to outsource and when to conduct pharmacovigilance in-house is a crucial decision.