FDA’s New Clinical Trial Guidance Allows you to Streamline!

On May 2, 2023, FDA published a draft guidance for Decentralized Clinical Trials for Drugs, Biological Products, and Devices – Guidance for Industry, Investigators and Other StakeHolders. In this draft guidance, the FDA states that “regulatory requirements for...

Device Software and Data Collection Transparency

Decentralized clinical trials (DCTs) are becoming more and more popular as a means of improving patient access and participation, reducing costs, and increasing efficiency. However, DCTs also present unique challenges in terms of data collection and management,...