FDA recently issued a warning letter to clinical investigator Betty Tuller, PhD, after she purportedly violated several requirements under 21 CFR Part 312 while working at Florida Atlantic University’s Center for Complex Systems and Brain Sciences. According to the...
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...
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...
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...
A report released Feb. 29th by the Institute of Medicine (IOM) provided a review of the benefits of current federal laws that offer incentives for or require drug and biologic developers to conduct pediatric studies. The report also highlighted several areas where...
This event will be a great gathering for clinical research professionals. Gretchen Bowker, Pearl IRB COO is speaking at the event. The title of the event is: Ask the IRB’s- Answers might be different than what your IRB is telling you. Pearl will also be...
