Chris Rush

Greenlight Guru

Chris Rush is a biomedical engineer and has been in the medical device field for more than a decade. He spent several years managing clinical studies for Class III devices in pivotal studies, PMA studies, and postmarket registries. He is currently a solutions engineer at Greenlight Guru.

Tue, 07/30/2024 - 12:03
Are Remote Elements Right for Your Next Study?Decentralized clinical trials
Wed, 12/04/2024 - 12:01
The U.S. Food and Drug Administration (FDA) recently published new guidance on conducting clinical trials with decentralized elements. It offers recommendations for sponsors, investigators, CROs, and other parties that are interested in implementing…
Real-World Data and Real-World EvidenceWhen and how to use them
Wed, 11/13/2024 - 12:01
While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence. Real-world data (RWD), which typically…
Data Management and Reporting in FDA-Regulated Clinical TrialsWalking you through the guidance and regulations
Tue, 07/30/2024 - 12:03
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data…