INSIGHTS & ARTICLES

ICH E6(R3) is redefining Clinical Quality Assurance globally. Sponsors must now embed Quality by Design, RBQM, continuous inspection readiness, and stronger vendor oversight across all trials. Read our latest article on what this means for clinical, IVD, and CDx programs.

By David Petrich, Landrich Group Co-Founder and VP of Quality and Regulatory In part 1 of our series on consumer diagnostics, we reviewed the secular trends driving growth in this sector of IVD product diagnostics and clinical trials in the coming decade. This second part of our series focuses on key considerations for trial management and regulatory affairs. In a Boston courtroom last month, the former CEO and two high-ranking executives of the IVD firm Magellan Diagnostic

By David Petrich, Landrich Group Co-Founder and VP of Quality and Regulatory The International Council for Harmonization (ICH) announced the adoption of its E6(R3) guidelines in 2025. These changes reflect the need for modernized guidance on clinical trial conduct. The clinical research space has undergone rapid technological and procedure change in the five years since the COVID-19 pandemic began. ​ The ICH, which serves as a global forum for regulatory authorities and the m

By David Petrich, Landrich Group Co-Founder and VP of Quality and Regulatory Since the COVID-19 pandemic, clinical trials have transitioned from traditional monitoring methods towards a more flexible approach known as Risk-Based Monitoring (RBM). RBM offers a potential paradigm shift in the speed, efficiency, and costs for bringing new therapeutic, medical device, and diagnostic products to market. ​​ Drug and medical device development budgets face intense pressure, with US

Learn how clinical trial risk management helps identify, assess, control, and monitor risks to protect study participants, maintain data integrity, and support regulatory compliance.