Based on the effects that social distancing and quarantine are having on current and upcoming clinical studies, decentralization offers many benefits over the traditional approach to clinical trial execution – leveraging digital technology and home health to facilitate site-less trials and patient-centric protocols.
Biorasi, a leading global full-service contract research organization (CRO), has been named on the Inc. 5000 list of the fastest-growing private companies for 2020.
The Evolution of Digital Therapeutics and the Need for Clinical Evidence: Lessons Learned from DTx West 2020
With digital therapeutics experiencing an evolution, Biorasi was on hand at DTx West 2020 to highlight the importance of evidence as a differentiator in clinical trials. Read more about our event experience >>
When stem cell industry innovators from across the globe congregated in Miami at the end of January 2020 to discuss the current state and future expectations of the regenerative medicine industry, Biorasi had more than one reason to be excited about the event. Read the full article for highlights >>
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.