Articles & News

From a data protection viewpoint, clinical trials encompass a range of tasks that can be daunting for clinical sponsors. The sheer volume of compliance activities required for clinical operations is staggering, including ICF reviews, vendor assessments, protocol reviews and CTIS statements, Data Protection Impact Assessments, Records of Processing, and more. Amidst this whirlwind of obligations, one requirement often emerges as an unexpected challenge for clinical sponsors without a presence in the EU or UK: appointing a data protection representative.‍

Here's our newest conversation with Brij Mohan Lal Srivastava, CEO and Co-founder of Nijta, a company at the forefront of AI in speech anonymization. The realm of voice is an emerging and fascinating area within the life sciences, and with every new domain, issues of privacy come to the forefront.

The Biden Administration issued an executive order authorizing the Department of Justice (DOJ) and other federal agencies to take steps to prevent “the large-scale transfer of Americans’ personal data to countries of concern.” It represents an effort by the administration to put more safeguards on the data broker industry and limit the ability of US adversaries to purchase granular data on American citizens.

The European Parliament is scheduled to vote on the legislation March 13, and one of the lawmakers leading the legislation said he expects it to pass easily. Under the current timeline the law would largely take effect in 2026, although some provisions would kick in this year.

Data mapping and data flow are crucial components in the management of data, especially in the context of clinical trials. These processes not only ensure compliance with data protection regulations but also enhance the integrity and security of data handling. Here's a breakdown of the key points from your text, specifically tailored to emphasize their significance in clinical trials.