Blog
Pearl IRB announces HBA Indiana Chapter sponsorship
We are excited to announce our sponsorship of the Healthcare Businesswomen’s Association- Indiana Chapter. HBA is a global nonprofit organization comprised of individuals and organizations across the healthcare industry. The core purpose of HBA is to...
FDA: remaining proposed and final rules for 2017
According to an updated list of Department of Health and Human Services rulemakings, the US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017. Proposed Rulemakings Among the proposals...
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...