The COVID-19 pandemic created challenges and opportunities in the implementation of decentralized solutions. To fully realize all the advantages and benefits of a truly decentralized approach, partnering with a reliable […]
The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss some considerations for successfully implementing decentralized solutions.
The FDA continues to release additional information and update their website as the COVID-19 pandemic continues and both regulatory professionals and drug developers react to the potential for novel and repurposed products to treat COVID-19. This blog post is the latest installment in a series of COVID-19 related blog posts and updates information provided in a recent webinar.
With the industry-wide push towards patient-centricity, electronic clinical outcome assessments (eCOAs) have become a more widely used strategy to streamline patient data collection, provide real-time access to data for review and monitoring, enhance patient engagement, and improve the integrity and accuracy of clinical studies. Rho answers some commonly asked questions about eCOAs.
As with other incentive programs, FDA created the Rare Pediatric Disease (RPD) designation to encourage drug development in products with questionable financial viability; in this case, the treatment of certain rare pediatric diseases. One of the main benefits of RPD designation is the potential to receive priority review vouchers, which can be used to obtain priority review on a subsequent human drug or biologic application, should the product with RPD designation be approved.
Development programs in rare diseases are becoming a major focus for small biotech and pharmaceutical companies. A crucial consideration is the choice of control group used to assess efficacy. Through recent case studies, we will discuss factors to consider, appropriate analysis,
If you are considering development of a product for treatment of COVID-19 or COVID-19-related indications, ensuring no time is wasted between idea and engaging FDA via the appropriate pathway with all the required information is essential. In this webinar, we’ll review the pathways you might consider,
Successful implementation of RBQM is a challenge many in our industry are facing. To understand what it is and how it impacts the management of your clinical trial, this webinar will address what exactly E6R2 is. We will use Rho as a case study for designing and implementing a strategy, discuss common
