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Press Releases

Rho Names HR Expert Pam Myers as Chief People Officer  

Rho Names HR Expert Pam Myers as Chief People Officer 

Rho_Resource_Blog
Blog Post

Innovative Designs in Early-Stage Studies

Innovation in early-stage studies presents the best opportunity to streamline the drug development process. Such designs may not only reduce costs and accelerate timelines but give us better flexibility to address the questions of interest in an increasingly evolving clinical development landscape.

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Blog Post

Transitioning Trials Approved under the Clinical Trials Directive to the Clinical Trials Regulation and CTIS

The new European Union (EU) legislation regulating clinical trials harmonises the processes for assessment and supervision of clinical trials throughout the EU. It enables sponsors to submit 1 online application via a single platform (CTIS) for approval to run a clinical trial in several European countries, making the conduct of such multinational trials more efficient.

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Blog Post

Planning for a Successful Centralised Marketing Authorisation Application in the European Union

In the dynamic landscape of pharmaceuticals, obtaining a centralised marketing authorisation in the European Union (EU) is a crucial step for companies looking to bring their medicines to a broad market. The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorizations in the EU, offering a streamlined process that enables companies to submit a single marketing authorisation application (MAA) and to market their products across the entire European Economic Area (EEA), which includes the EU countries, Iceland, Norway and Liechtenstein, based on a single authorisation.

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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.

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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.

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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.

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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.