Most device companies spend years and large budgets getting a product approved. Once the device is on the market, the team moves on to the next launch, and post market surveillance gets whatever time and money are left.  That is a costly mistake. Regulators now treat data from post market surveillance medical devices programs as […]

Your team might get this one wrong. For most device companies, a clinical trial is the biggest cost and the longest delay on the road to market. Some run a study they never needed. Others skip one and then get stuck in regulatory review for months.  The real question is not “trial or no trial?” […]

Most clinical trials do not slip because the science fails. They slip because patients do not enrol fast enough.  According to National Library of Medicine, recruitment can take up to 30% of the drug development timeline, and delays of one to six months are common.   For pharma teams, this makes clinical trial recruitment strategies one […]

In clinical research, a blood draw or a tissue sample is a valuable raw data. If that sample is damaged in the first minutes after it is taken, no lab test, statistician or software tool can fix it later.  That is why biospecimen collection deserves the same careful planning as protocol design or site selection. […]

Imagine spending months and a six-figure budget on a supplement launch, only to watch a competitor’s bottle outsell yours because of three words on the label: “clinically proven results.”   That gap between a good product and a proven one is often what decides who wins the shelf. Supplements do not need FDA approval before they […]

Human clinical trials are supposed to answer one simple question: does this treatment work, and is it safe? But the first time a new drug is given to a person, known as a first in human study, is where many biotech programs quietly go wrong. The problem is rarely bad luck. It is usually study […]

Introduction  The oncology landscape is undergoing a remarkable transformation. Advances in precision medicine, immunotherapy, cell and gene therapies, antibody-drug conjugates (ADCs), and targeted therapies are redefining how cancer is diagnosed, treated, and monitored. These emerging oncology modalities are enabling more personalized treatment approaches, improving patient outcomes, and accelerating the development of innovative therapeutics.  Behind these […]

Most articles on choosing a CRO partner tell you the same thing. Look for experience. Check regulatory expertise. Ask about quality systems. This advice is not necessarily wrong, but it is not very useful either. Almost every CRO company will claim to tick these boxes on their website.  The real problem is different. Sponsors usually know what to look for. What they don’t have […]

Most biotechs write their protocol first. Then they bring in a CRO to help with submissions and operations. It feels like the natural order. Design the science, then handle the paperwork.  This order is usually a mistake. By the time a CRO gets involved, the big decisions are already locked in. Endpoints are chosen. The dose escalation […]

If your pharma company is planning its first trial, or bringing in a new team to run one, you have probably heard people throw around terms like “Phase II” or “Phase III” in meetings. It can feel like everyone else already knows what this mean, and you are the only one guessing.  In this blog, we have broken down clinical […]