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Blog Post

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?

Rho_Resource_Blog
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.

Rho_Resource_Blog
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.

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Webinar

Hindsight is so 2020: Getting Ahead of CNS Trial Enrollment in a Rapidly Changing Clinical Landscape

The past six months have highlighted both existing and unexpected enrollment challenges, as sponsors, CROs, and sites have been pressed to evolve their recruitment strategies.  Join us as Rho experts discuss their approach to adapting CNS trial enrollment to a rapidly changing clinical landscape,

Rho_Resource_Blog
Blog Post

New FDA Guidance on Enhancing the Diversity of Clinical Trial Populations, and some great related resources

The FDA recently published a new guidance on diversity in clinical trial populations, which “recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.”