by Jessica Etheridge | Aug 27, 2024 | Articles, Clinical Investigation
Contract Research Organizations (CROs) play a significant role in supporting regulatory compliance in clinical investigations. Here are several ways CROs support regulatory compliance: 1. Expertise in Regulatory Requirements: CROs have in-depth knowledge of regulatory...
by Jessica Etheridge | Sep 20, 2023 | Articles, Clinical Investigation
The field of diagnostic devices is complex, highly regulated, and fundamentally vital to public health. When designing, developing, and commercializing a new diagnostic product the stakes are high. Partnering with a CRO that holds an ISO 13485:2016-certified quality...
by Jessica Etheridge | Sep 20, 2023 | Articles, Clinical Investigation
Introduction The development and commercialization of diagnostic devices are a complex endeavor that involves a multitude of steps, from the initial conceptualization to market launch and post-market surveillance. Given the critical role diagnostic devices play in...
by Jessica Etheridge | Jun 29, 2023 | Articles, Clinical Investigation
Clinical trials are research studies that involve testing new treatments, therapies, and interventions on volunteering participants to determine the effect on human health. They play a crucial role in medical advancements as they help to bring these new drugs,...
by Jessica Etheridge | Apr 19, 2023 | Articles, Clinical Investigation
NAVIGATING REGULATORY APPROVAL WITH A CRO IN IVD DEVELOPMENT The development and commercialization of medical devices, including diagnostics, require a significant investment of time, resources, and expertise. To navigate the complex regulatory approval process and...
by Jessica Etheridge | Mar 2, 2021 | Clinical Investigation
INSFRASTRUCTURE, TECHNOLOGY AND REGULATION FOR DCTs In this presentation, we discuss how decentralized clinical trials provide better patient engagement by removing common barriers that can have a negative impact on recruitment and retention. We examine various...
