Blog

Case Studies Released

Pearl is excited to announce its release of several case studies.  Check out our case study section to see how Pearl offers real solutions to companies ranging from small start-ups to large multi-nationals.  To view our IRB case studes, click here.  To see the breadth...

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INpact Meeting April 20th

Please join us for the April 20th, 2012 INpact meeting from 11:30AM-1:00PM in Indianapolis, Indiana.  Gretchen Bowker, Pearl Pathways COO, will serve as a panelist for the discussion.  The topic of discussion will be about the FDA 510(k) process and how it will change...

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FDA Public Hearing April 23-24, 2012

The FDA will hold a 2 day public hearing to obtain input from those interested in FDA's scope and direction in modernizing regulations, policies, and practices that apply to clinical trials of FDA-regulated products. Anyone interested is strongly encouraged to join...

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New FDA Informed Consent Requirements

In February, FDA released a new guidance document entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)”.   The purpose of the guidance is to help small businesses, particularly clinical trial sponsors, investigators, and institutional review...

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Are clinical trial patients doing more harm than good?

Several sources have recently pointed to possible links between poor patient adherence during clinical drug trials and unexpected adverse effects—as well as personal injury cases—once the drug is approved and marketed.  Chief among these sources is the Consumer Health...

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