RECENT POSTS

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.

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 Diagnostics pleaded guilty to criminal charges with the possibility of up to three year

The International Council for Harmonization (ICH) announced the adoption of its E6(R3) guidelines last month. 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 medical industry, now provides greater clarity for globally harmonized Good

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 health care spending predicted to reach 20% of US GDP in the coming decade, d

Clinical Trials are essential for developing new treatments, drugs, and medical devices. They are carefully designed and conducted to evaluate their safety and efficacy. However, conducting Clinical Trials also involves a certain degree of risk for the participants and the trial sponsors. Risk Management is, therefore, a critical component of any clinical trial. It involves identifying potential risks and implementing strategies to minimize or mitigate them. What is Risk M