Featured Articles
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Programs To Support Drug Development In Infectious Disease
11/23/2020
Programs such as Generating Antibiotic Incentives Now (GAIN), its Qualified Infectious Disease Product (QIDP) Designation, and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), described below, were designed by the FDA to streamline development and encourage investment into targeting infections that lack effective treatments, but taking full advantage of each isn’t easy without a comprehensive knowledge of the rules, incentives and eligibility requirements.
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Introduction To Decentralized Clinical Trials
11/18/2020
Many terms are used to describe decentralized clinical trials (DCTs) such as ‘virtual’, ‘remote’, ‘site-less’, and ‘hybrid’ but what is the exact definition? This blog clarifies the definition of DCTs and highlights their benefits and associated technologies.
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A Day In The Life Of A CRA During COVID-19: An Interview With Raquel Telfer
11/18/2020
Raquel Telfer, Senior Clinical Research Associate at Rho, has been in the clinical research industry for over 10 years. In this blog she 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
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Statistical Guidance For COVID-19 Impacted Trials
10/15/2020
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. Following is a brief summary of the FDA guidance and some examples of activities Rho has undertaken to maintain trial integrity and patient safety in ongoing and upcoming clinical trials.
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Tips For Planning And Executing Successful Critical Care Trials During COVID-19
9/1/2020
COVID-19 has impacted the clinical research landscape completely, prompting special attention toward critical care studies that require a nuanced approach to patient centricity and patient safety measures. Through our expertise and experience with critical care studies, we’ve been able to leverage our lessons learned into successful strategies that mitigate risks exacerbated by the pandemic.
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Conducting Successful Site Qualification Visits Using Virtual Solutions
8/25/2020
With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate meaningful evaluations and assessments, safeguarding patient safety and data integrity. Read how a CRO conducted site qualification visits virtually, which required creating hybrid approaches to utilizing our virtual platforms.
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Mitigating COVID-19 Risks In A Complex, Fast-Moving Pain Program
8/19/2020
A cutting-edge biotech was running a program with three active, concurrent, pain studies across 25 sites and 218 patients, with interim database locks scheduled during the summer of 2020 and final database lock deadlines looming close behind. The COVID-19 pandemic put that all on the line.
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RMAT Designation…What Is It And Is It Right For Your Therapeutic Product?
8/17/2020
The US FDA has a framework for the regulation of regenerative medicine products and has plans to support and expedite the development of regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps). Here is what you need to know to determine if a drug is eligible for regenerative medicine advanced therapy (RMAT).
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Antiviral Products In The Pre-IND Phase
8/3/2020
Productive pre-IND interactions with FDA are important to the success of any drug development program, including infectious disease product development. This step provides opportunities for makers of infectious disease products to engage with FDA by facilitating early communications between the Division of Antivirals or the Division of Anti-Infectives within OID and sponsors/investigators of potential new therapeutics. Here, we specifically discuss antiviral products at the pre-IND stage, and unique considerations for these products.
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CRO Implements A Successful, Patient-Centric Decentralized Solution For An On-going Clinical Trial During COVID-19
8/3/2020
A mid-sized biotech company was in the middle of conducting an open-label long-term safety study with 137 active patients across 25 sites in the US and Canada. Then the COVID-19 pandemic hit. Rho developed a customized and decentralized solution for their study that would ensure patient safety and data quality while allowing their study to progress according to FDA guidelines for conducting research during this pandemic.