Featured Articles
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Recruitment, Retention, And Relationships In Your Rare Program
4/17/2020
When it comes to treating rare diseases, Rho understands that advancements don’t come easy and the rarity of the diseases alone can hinder patient recruitment and retention.
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6 Things To Consider When Selecting A CRO For Your Next Pain Trial
4/15/2020
Pain trials are unique among clinical trials, and it is important to select a clinical research partner that understands and embraces the many differences. There are several key factors to consider when choosing a CRO to work with on your next pain trial.
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5 Challenges To Starting A New Parkinson’s Disease Clinical Trial
4/14/2020
Clinical studies in Parkinson’s disease (PD) have a high degree of complexity. Researchers working in this area face unique challenges in both study design and conduct, which are critical to consider during the planning phase of a clinical trial. Considering the following early in your PD clinical trial planning process can help ensure a high quality clinical trial.
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Changes To Study Visits And Assessments During COVID-19: Subject Safety Considerations
4/14/2020
The COVID-19 pandemic has understandably generated a surge of concern among clinical researchers about how best to minimize the risk to study subjects of exposure to COVID-19 while also preserving study integrity and a favorable risk-benefit of study participation for subjects. Here we shed some light on specific topics that might be considered during this time.
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COVID-19 FDA Response: Guidance Released For Conduct Of Ongoing Trials
4/13/2020
Since the emergence of Coronavirus Disease 2019 (COVID-19) in the US, the FDA has released new guidance and information rapidly and continuously in a comprehensive response to the current pandemic. This blogs discusses topics covered in the guidance and what they mean for sponsors, investigators, and IRBs.
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The H1N1 Study: Conducting Public Health Research During A Pandemic
4/7/2020
This article describes Rho’s involvement in a recent clinical trial that assessed the safety and immunogenicity of the 2009 H1N1 vaccine in adults and children (aged 12-79 years) with severe asthma.
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Breakthrough Therapy Designation And Accelerated Approval With Inadequate CMC Program Development: Hurry Up And Wait
3/26/2020
This article examines the development and marketing application review processes for the chemistry, manufacturing, and controls (CMC) aspects of products targeting serious conditions in the context of the FDA’s expedited accelerated approval (AA) and breakthrough therapy designation (BTD) programs.
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Tips For A Smooth Marketing Application Submission
3/26/2020
Marketing application submissions, including NDAs, BLAs, and MAAs, are the culmination of years of research and the final hurdle before a product makes it to market. This article shares tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.
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FDA's Project Orbis: Trendsetter Or One-Off
11/6/2019
With the announcement of Project Orbis, FDA’s Oncology Center of Excellence (OCE) excited both patients and the pharmaceutical industry with the program’s future possibilities for collaborative regulatory authority interaction in accelerating product approvals worldwide. So the question immediately comes to mind as to whether this is the tip of the iceberg for process improvement for future coordinated international regulatory marketing approvals or is this an isolated incident where all the stars were aligned.
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Risk Evaluation And Mitigation Strategies: FDA Guidances For Assessing Effectiveness
8/5/2019
In January 2019, the Food and Drug Administration (FDA) released 2 draft guidance documents regarding assessment of Risk Evaluation and Mitigation Strategies (REMS). These documents are meant to provide industry additional information to more accurately assess the effectiveness of their REMS. This article gives an overview of each of these documents and what they could mean for you.