QbD IVD | Qarad

Oncology IVD development rarely stands still. Science evolves, technologies change and clinical practice moves with them. So how do you build an IVD programme that can adapt without sending you back to square one? This article explores three disciplines that can help you build for change from the start: state of the art, risk management and intended purpose. Read the full article 👇

Designed for approval doesn't automatically mean ready for adoption. Discover where oncology IVD clinical studies can slip, and what to consider before your study design is locked in. 👇

Regulatory approval is essential. But for an oncology IVD, it isn't the only measure of a successful clinical study. Study design choices can also influence how well your diagnostic fits clinical practice and how confidently it can be adopted after approval. In this article, we look at where oncology IVD clinical studies can slip, from study design and endpoints to samples and technical complexity. Read the full article 👇

Your intended purpose defines more than you might think: claims, study design, evidence needs and your route to market. Get the foundation of your oncology IVD right from the start. 👇

Science changes. Clinical practice evolves. Your oncology IVD programme needs to keep up. Discover how to build for change from the start. 👇

Your intended purpose is more than a regulatory requirement. It shapes your clinical claims, study design, evidence needs and ultimately your route to market. And getting it wrong early can have consequences throughout your oncology IVD development programme. In this article, we look at why intended purpose deserves strategic attention from the start, and how to define it before key decisions become difficult to reverse. Read the full article 👇