Clinical Trials and Research
Simonne counsels life sciences companies, including major pharmaceutical, biotechnology and medical device companies to support drug and device research and development. She routinely negotiates and supports the development of clinical trial agreements, informed consent forms, vendor and CRO agreements, and other research collaboration agreements in the U.S. and abroad. She also advises clients on collection and use of clinical data, including pseudonymized research results, genetic samples and de-identified health data.
Privacy and Cybersecurity
Simonne advises clients in a variety of sectors on compliance issues related to the GDPR, CCPA, HIPAA, CAN-SPAM Act, TCPA and other privacy statutes and regulations. In particular, she works closely with clients to manage compliance with the CCPA/CPRA and other state data protection laws. She also drafts and negotiates data protection agreements, consumer-facing privacy notices and policies, and internal privacy resources. Finally, Simonne helps clients navigate international data transfer restrictions to facilitate cross-border transactions.
From 2020-21, Simonne clerked for U.S. Magistrate Judge Joel C. Hoppe in the Western District of Virginia.