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Protocol Planning and Design for Quality Decentralized Clinical Trials

Decentralized clinical trials allow a patient-centric approach to data collection and communication compared to traditional clinical trials. While additional planning may be needed to implement a decentralized trial the most important question is the same. What is the research question?

Blog Post

FDA COVID-19 Treatment Development Update

With the recent emergency authorizations of the Pfizer-BioNTech COVID-19 vaccine by the regulatory authorities in the United Kingdom, Canada, and United States, we are on the verge of a significant breakthrough in coping with the COVID-19 global pandemic.

Blog Post

Nonclinical Considerations for 505(b)(2) Development Programs

Applicants planning to submit a product for approval through the section 505(b)(2) new drug application (NDA) can benefit from a less costly development program with the potential for a faster route to market than a traditional 505(b)(1) program. Sponsors submitting a product through this pathway can generally plan for a nonclinical development program that is substantially curtailed compared to what is required for submission via the section 505(b)(1) stand-alone NDA pathway.

Heather Kopetski
Blog Post

Introduction to Decentralized Clinical Trials

Many terms are used to describe decentralized clinical trials (DCTs) such as ‘virtual’, ‘remote’, ‘site-less’, and ‘hybrid’ but what is the exact definition? The FDA recently defined DCTs as the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data. We outline the different approaches to implementing DCTs.

Blog Post

A Roadmap to Designing and Executing a Quality Decentralized Clinical Trial

Decentralized clinical trials (DCTs) are playing a role in an increasing number of drug and biologics development programs. While much has been written about the potential benefits that these trials can bring, our experience in this space has taught us that there are several questions that sponsors should be asking as they consider the end-to-end execution of a DCT.

Blog Post

A Day in the Life of a CRA during COVID-19: An interview with Raquel Telfer

Raquel Telfer, Senior Clinical Research Associate at Rho, has been in the clinical research industry for over 10 years. She is currently working on a cystic fibrosis study and travels throughout the country monitoring clinical sites to ensure testing and data integrity. Raquel speaks candidly about her experience as a CRA, provides examples of how the clinical landscape is evolving for CRAs and patients, and how she finds energy and inspiration during these unsettling times.

Heather Kopetski
Blog Post

Statistical Guidance for COVID-19 Impacted Trials

Clinical trials conducted during the COVID-19 pandemic have been impacted by public health measures to control the virus. In June, the FDA released a guidance on  Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency. We summarized the FDA guidance and some examples of activities Rho has undertaken to maintain trial integrity and patient safety in ongoing and upcoming clinical trials.

Blog Post

Conducting Successful Site Qualification Visits using Virtual Solutions

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.