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On-site facility evaluations have historically provided us with the insight necessary to determine site performance and viability for our clinical trials. With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate those same meaningful evaluations and assessments, safeguarding patient safety and data integrity.

A cutting-edge biotech was running a program with three active, concurrent, pain studies across 25 sites and 218 patients, with interim database locks scheduled during the summer of 2020 and […]

As research teams develop more cellular and gene therapy products for the treatment of a wide array of medical conditions, the need for custom nonclinical and clinical programs required to support market approval of products that are based on human cells, tissues, or HCT/P will rise. And for RMAT designated products, the study designs may be substantially different from more traditional IND programs.

Productive pre-IND interactions with FDA are important to the success of any drug development program, including infectious disease product development. The Pre-IND Consultation Program through the Office of Infectious Disease (OID), one of 27 review divisions within the Office of New Drugs, provides opportunities for makers of infectious disease products to engage with FDA by facilitating early communications between the Division of Antivirals or the Division of Anti-Infectives within OID and sponsors/investigators of potential new therapeutics – these products include drugs and therapeutic biologics for the treatment of bacterial, fungal, and viral infections (including SARS-CoV-2 infection).

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.