Kristen Rosati and Amanda Coulter Advise AHLA on COVID-19’s Impact on Clinical Trials
The COVID-19 public health crisis is having a profound impact on all aspects of the health care system. Kristen Rosati and Amanda Coulter teamed up to inform the American Health Law Association (AHLA) about how it will affect clinical trials.
AHLA Weekly published their article, “How the COVID-19 Pandemic Immediately Impacts Clinical Trials: Considerations for Sites and Investigators,” which addresses the need for sites and investigators to be simultaneously rigorous and flexible. It also covers determining criteria to determine which trials will continue; vetting, implementing, and documenting changes for continuing trials; and communicating changes with sponsors and participants.
Kristen, a nationally recognized and respected leader in health care law, has served in numerous leadership positions within AHLA – including president of the association from 2013-2014. She is considered one of the nation’s leading Big Data and HIPAA compliance attorneys. With extensive experience in data sharing for research and clinical integration initiatives, clinical research compliance, and biobanking and genomic privacy, she regularly speaks on these topics at national conferences and forums.
Amanda advises clients in the health care industry on clinical research matters. She has extensive experience with industry-sponsored clinical trial agreements, developing research compliance policies and processes, template forms, and template agreements. Additionally, she assists clients by reviewing and negotiating confidentiality agreements, data use agreements, business associate agreements, and federal grants and subcontracts.
Read the full article here.