Clinical Trial Resources
Clinical Trial Resources
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.
What is AKI? AKI is a sudden, reversible decline in the kidney’s glomerular filtration rate (GFR); in other words, its ability to filter metabolic waste. This kidney damage causes an elevation of serum urea and creatinine, which affects the body's ability to function properly. Most AKI cases are reversible. However, it's important to treat AKI as early as possible to avoid its progression to chronic kidney disease or kidney failure.
Researchers are studying a few new and existing drugs to treat FSGS. FSGS needs a novel medication that regulates both high body fats and inflammasome inhibition via upstream innate immune system to block intracellular initiation of inflammatory cascade and extra cellular inflammation. Over the past five years, nearly 30% of Biorasi-initiated or ongoing studies involved chronic kidney disease. Our experience allows us to develop successful nephrology clinical trials.
To unlock more targeted, effective treatments, genetics researchers are exploring mutations responsible for some of the most common motor neuron diseases. These discoveries may lead to gene therapy treatment routes that do a better job of slowing disease progression than current medications. Much like gene therapy in oncology has brought improvement in cancer regression in recent years, we believe gene therapy—particularly therapy that targets and modulates RNA—is the future of neurology.
Biorasi’s Oncology Center of Excellence remains at the forefront of this exciting field. Our team of clinicians, program managers and other experts stay up to date on the latest developments, from Tumor Infiltrating Lymphocyte (TIL) therapy to gene therapy advances. This experience, combined with Biorasi’s worldwide site network and data-driven approach, allows us to guide oncology programs to success—on time and on budget.
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.
How to run a more efficient pediatric clinical trial: Although pediatric trials overall cost roughly the same as adult clinical trials according to one analysis, they generally produce a more modest return on investment. To ensure your neurodevelopmental or other pediatric study completes in a cost-effective, efficient manner, follow these tips:
C3 glomerulopathy (C3G), a rare kidney disease, affects only two or three people out of every one million. That’s only a couple people out of the entire population of San Jose, California or Austin, Texas. Although C3G only affects a select few, without treatment it can lead to severe kidney damage and failure, necessitating expensive dialysis or transplant. To date, there is no specific, effective therapy. As a CRO that understands the challenges involved in researching rare disease treatments, we’re here to help drug developers deliver the most effective clinical trials possible—on time and on budget. Speak with one of our rare disease experts today to find out how we can help you develop your next rare disease program.
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.