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Blog Post

How Many Strata can my Randomized Clinical Trial have?

When running a randomized clinical trial, if there are factors which are known during the study design phase to influence study results, it may be advantageous to utilize a stratified randomization which ensures each prognostic factor is balanced between treatment arms.

News

Tonix Pharmaceuticals Announces Engagement of Rho as CRO to Support Submission of New Drug Application to the FDA for Approval of Tonmya™ for the Management of Fibromyalgia

Rho is thrilled to announce our unwavering support for Tonix Pharmaceuticals as they prepare to submit their New Drug Application (NDA). Serving as a dedicated partner to Tonix, we are committed to providing the necessary resources and expertise to support the next steps toward regulatory approval of Tonmya™  for the management of fibromyalgia. Our collaboration underscores our shared dedication to advancing healthcare solutions that improve patient outcomes and enhance the quality of life. We are grateful to be a part of such an exciting partnership as we continue to champion breakthrough advancements in drug development.

Rho_Resource_Blog
Blog Post

Handling Efficacy Data in Long-Term Ongoing Studies for a Submission

Regulatory reviewers will expect a Clinical Study Report (CSR) and supporting electronic data packages for these studies, but that doesn’t have to delay our filing date. We have outlined suggested techniques to provide the agency with everything they need to review the application, without compromising the integrity of the ongoing study.

Rho_Resource_Blog
Blog Post

Updated Guidance on Formal Meetings Between the FDA and Sponsors: What Has Changed?  

In September 2023, the FDA announced a new draft guidance, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” The new guidance provides recommendations for formal meetings conducted by industry sponsors or applicants with the FDA for the development of either drug or biological drug products and does not apply to abbreviated new drug applications, applications for biosimilar biological products, or medical devices.

Rho_Resource_Blog
Blog Post

Confirming Confirmatory Evidence

“Do the studies in our program meet the FDA standards for demonstrating effectiveness?” is a question that sponsors frequently ask here at Rho. Demonstrating the efficacy of your product is an integral component of an application, but the flexibility surrounding what qualifies as substantial evidence from the FDA’s perspective can often leave you scratching your head.

Rho_Resource_Blog
Blog Post

PRO Data in Cancer Clinical Trials

The US Food and Drug Administration (FDA) recently finalized a guidance document outlining the agency’s thinking on Submitting Patient-Reported Outcome Data Cancer clinical Trials. The guidance illustrates the importance of choosing a PRO vendor that is capable of capturing the recommended content and framework as source data if possible.  This will reduce the need for time-consuming and potentially error prone data manipulation in SDTM and ADaM.

Rho_Resource_Blog
Blog Post

CDISC Standards for COAs using Item Response Theory (IRT)

The US Food and Drug Administration (FDA) recently finalized a guidance document outlining the agency’s thinking on Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory. The guidance lays out technical specifications to consider when submitting clinical outcome assessment (COA) information that uses Item Response Theory (IRT) in a marketing application.

News

Transformation in Trials: Becky Baggett on the Science and Strategy Behind Successful Clinical Trials

Tune in to hear Becky Baggett, Rho’s Associate Vice President of Project Delivery, navigate the world of clinical trials by “unraveling the complexities and enlightening us on the crucial collaboration between the sponsor and the CRO, the importance of clinical research sites, data management, and project management. She underscores the absolute necessity of establishing solid relationships, trust, and experience in this highly controlled and regulated field.”

Rho_Resource_Blog
Blog Post

Bringing a Medical Device or Drug to Market – Part 1: How to Tell if Your Product is a Medical Device or a Drug

Are you developing a new product and wondering whether it falls under the classification of a drug or a medical device?  While some products clearly fit in one classification or the other, with advancements in science and technology, products can have features that blur the lines between drug and device.  Navigating the regulatory landscape is often a complex but critical aspect of bringing your innovation to market.  In this series, we will explore the regulatory mechanisms available to help you distinguish a medical device from a drug product and to utilize FDA’s regulatory pathways specific to each, particularly in early development.