Castor Blog

Cybersecurity has become a concern for Digital Therapeutics (DTx) developers and regulatory bodies. Learn to balance functionality & security.

Researchers are looking to incorporate remote technologies into medical device trials for a wide range of device classifications. This article explores current regulations for various classes of medical devices and how this will impact the need for participants to visit research sites throughout the trial.

A robust digital therapeutics cybersecurity system is integral to protecting users’ sensitive information helps meet regulatory requirements and maintain public trust.

The Castor team is thrilled to see an increasing emphasis on diversity of race, gender, and even geography amongst clinical trial participants. Critically, experts call for not just increased diversity on a statistical basis, but that the studied population is representative of the distribution of the disease.

Although eConsent struggled to gain momentum and wider acceptance pre-pandemic, it’s now a major part of clinical research. In this article, learn three ways eConsent addresses the requirements for valid informed consent.

DTx represent an emerging field of software-driven, evidence-based products intended to “prevent, manage, or treat a medical disease or disorder.” Cybersecurity is a concern for DTx, whether they are being evaluated through clinical research or are aiming at market release.

At Castor, we hope to see DCT extend into all trials as we work alongside researchers in the pursuit of the ultimate goal of democratized clinical research.

Since it was first instituted in the 1960s, written consent to participate in research studies has undergone very little change other than tightening regulations and increased participant education of their rights.

Decentralized clinical trials (DCT) are collecting many kinds of data remotely, and this data is only expected to grow in volume. From wireless patches monitoring vitals to an ever-growing list of mobile-connected products, there are new data sources popping up almost everywhere.