A team from Biorasi was at ASN Kidney Week 2019. Breakthrough research and standout presentations marked this year’s @ASNKidney Week. Check out our report for the full scoop.
A team from Biorasi joined more than 900 leaders from the FDA, NIH and the pharma and bio-pharma industries for the National Organization for Rare Disorders (NORD) & Orphan Products Breakthrough Summit. Throughout two packed days of keynotes, breakout sessions and panel discussions, we gained valuable insight into the most urgent rare disease topics. Read about the a few takeaways from the event in this article.
As digital therapeutics are integrated into every aspect of the healthcare landscape, patients, payers, and providers are seeing an increasingly complex set of software-driven therapy options reaching the market. This rapidly expanding field has enormous potential but faces challenges at every stage, from design to patient perception. Focusing on the clinical trial stage, how does the trial of a digital therapeutic compare to that of a pharmaceutical? What are the specific challenges of running a digital therapeutics clinical trial, and how can sponsors adapt their approach for the highest chance of success?
In my previous article, I explained the types, causes and symptoms of Acute Kidney Injury (AKI). Here, I’ll share how physicians treat and manage AKI, as well as what to expect. CRRT or intermittent hemodialysis? To treat AKI, nephrologists primarily use renal replacement therapy (RRT), which includes intermittent hemodialysis, peritoneal hemodialysis, various forms of CRRT, and “hybrid” therapies such as prolonged intermittent renal replacement therapy (PIRRT) or sustained low-efficiency hemodialysis (SLED). A few clinical trials are taking a look at CRRT and intermittent hemodialysis under different conditions.
To execute precision medicine clinical trials, sponsors have adopted a range of new approaches, especially in early-stage studies. Many of these models allow sponsors to recruit more patients and bring drugs to market faster— goals drug developers in all therapeutic areas work toward.
As clinical trials become more complex and costly, the need for skilled project managers to oversee them is more important than ever. Project management methodologies drive success for enterprise organizations in all sectors. These same principles can help pharmaceutical and biotech companies run more efficient, successful clinical trials.
A clinical trial's operational efficiency depends on a solid oversight and response mechanism. Without vigilant monitoring, patient safety, data integrity, and the overall health of your trial come into jeopardy.
Why Do So Many Clinical Trials Fall Behind? Clinical trials are not immune to missed deadlines and cost overruns. However, with proper advance planning, you can up the odds of success and avoid major glitches. Our studies show that about 33% of all clinical trials are behind schedule at any given moment. These trials under-perform due to operational failures; meaning, they’re behind schedule, over budget, or the data produced lacks the quality needed to support an approval.
Have you ever put off talking to your significant other about expensive-but-necessary home repairs, for fear they'll hit the (leaking) roof? Most of us have, and [...]
Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.
Shortening the pharmaceutical development lifecycle and reducing costs with IBM Clinical Development®
Shortening the pharmaceutical development lifecycle and reducing costs with IBM Clinical Development® Overview: Costs, overheard and time spent are factors Biorasi strives to reduce for [...]
3 Measures to Overcome Operational Failures Every year, tens of thousands of clinical trials are initiated. Every year, thousands of those trials falter, and, if corrective [...]