Blog
Former CDC Director believes medicine should look beyond randomized controlled trials
Last Thursday, an article was published in the New England Journal of Medicine in which former director of the US Centers for Disease Control and Prevention Thomas Frieden called for greater use of alternative data sources, other than randomized controlled...
More seniors needed for clinical trials
According to a recent article on the Washington Post, more than 60% of cancer patients are older adults and that number could increase to 70% by 2040. However, seniors are rarely involved with clinical trials, leading to uncertainty with how treatments...
New EMA guideline on first-in-human clinical trials slated for 2018
The European Medicine Agency’s new guideline focuses on a sponsor’s responsibility to define the uncertainty associated with the medicines tested in clinical trials. The announcement occurred last week and the EMA guideline will go into effect on January...
Live webinar covering Japanese medical device approvals from Pearl IRB partner, Brandwood Biomedical- August 15th
On August 15th, join our partner Brandwood Biomedical to learn about the Japanese regulatory process. Prior to the internationally harmonized Japanese Pharmaceutical and Medical Devices Law, the process may have seemed obscure but things aren’t as complex as you may...
How FDA listens to the voice of patients
The Food and Drug Administration (FDA) vows to never forget that their efforts to evaluate and approve new medical products is done to benefit patients. Because of this they are constantly looking to find new ways to incorporate the views and expertise of patients and...