GDPR and Cross-Border Data Transfers in Clinical Trials
Cross-border data transfers are a critical yet complex aspect in clinical trials. With global collaborations becoming the norm, personal...
MSK iHub Challenge Part 2: Insights and Collaboration
Participating in the MSK Innovation Hub Challenge (MSK iHub Challenge) has been an eye-opening experience. As we transitioned from...
Ensuring Data Security Throughout the Trial Lifecycle
Clinical trials rely on robust data security measures to protect sensitive participant information, including personally identifiable information (PII) and...
Data Minimization: Balancing GDPR & Research Insights
Data minimization is one of the fundamental principles of the General Data Protection Regulation (GDPR), aimed at ensuring that...
Top 3 GDPR Compliance Questions in Clinical Trials
In the fast-evolving world of clinical trials, GDPR compliance is more than a legal obligation—it’s a pillar of trust,...
A Journey into the MSK iHub Challenge Part 1: Initial Approach
When Jae Zhong, a Senior Program Manager in Memorial Sloan Kettering (MSK)’s Office of Technology Development, contacted me on...
FDA Update on ICH E6, E8, QbD and RBM in Clinical Trials
The recent FDA workshop, “Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD)...
Dynamic Consent: A New GDPR Standard for Clinical Trials
In an era where data is the cornerstone of innovation, the concept of dynamic consent is emerging as a...
The Emergence of Superintelligence in Healthcare, Biotech, and Clinical Trials
The journey toward superintelligence unlocks extraordinary capabilities poised to revolutionize medicine and healthcare. These systems can process vast amounts...
How The Trump Administration Will Impact The Future of Clinical Trials and Biopharma
The re-election of Donald Trump in 2024 marks the start of a dramatic transformation in healthcare, biotech, and clinical...