JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more
The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more
The U.S. Securities and Exchange Commission’s (SEC) impending cyber disclosure rule, slated to commence on 15 December 2023, underscores an imperative shift towards a more transparent and accountable cybersecurity posture for...more
ACI’s Practical Guide to FCPA Data Analytics will take place on July 19 – 20, 2021 (EDT). This is a uniquely interactive event on how to harness data analytics, AI and machine learning for FCPA compliance, investigations and...more