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Blog Post

505(b)(2) Regulatory Pathway: What are the Advantages and Does Your Product Qualify?

The advantages afforded the 505(b)(2) applicant are significant in that the applicant is able to reference safety and efficacy data in the marketing application of the innovator product rather than conduct costly preclinical and clinical studies. Find out if your product qualifies.

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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.

Rho_Resource_Blog
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.

Rho_Resource_Blog
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.

Rho_Resource_Blog
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.

Rho_Resource_Blog
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.