PRA Health Sciences Ready to Navigate RACE Act Requirements for Pediatric Oncology
The Research to Accelerate Cures and Equity for Children Act(RACE)-goes into effect August 18th. The RACE Act amends the existing PREA-Pediatric Research Equity Act-and eliminates the exemption from PREA requirements for cancer drugs that have orphan status. The new law requires pediatric evaluation of new drugs intended for the treatment of adult cancers and directed at a molecular target substantially relevant to the growth or progression of pediatric cancer. A designated PRA team is ready to utilize their collective experience in pediatric clinical development to support RACE Act-focused initiatives.
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Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
