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A Day in the Life of a CRA during COVID-19: An interview with Raquel Telfer

Raquel Telfer, Senior Clinical Research Associate at Rho, has been in the clinical research industry for over 10 years. She is currently working on a cystic fibrosis study and travels throughout the country monitoring clinical sites to ensure testing and data integrity. Raquel 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.

Request for Proposal (RFP) for Clinical Trial Services
Blog Post

Conducting Successful Site Qualification Visits using Virtual Solutions

On-site facility evaluations have historically provided us with the insight necessary to determine site performance and viability for our clinical trials. With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate those same meaningful evaluations and assessments, safeguarding patient safety and data integrity.

Blog Post

Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD

Generating Antibiotic Incentives Now (GAIN) and the 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 therapies.

Joseph Watson
Blog Post

Orphan Drug Development and Single Trials

Since the enactment of the Orphan Drug Act in 1983, the number of orphan drug approvals has risen steadily. Rho has received an increasing number of sponsor requests for support of programs working towards an orphan drug approval. Can a product be approved with support from a single trial? To better understand when a single trial approval is possible, we look to FDA guidances.

Blog Post

North American Cystic Fibrosis Conference: Key Takeaways

The 33rd Annual NACF conference continues to be an action packed 3 days bringing together scientists, clinicians, health care providers, and caregivers to discuss the latest advances in CF research, care, and drug development.  These are our top 3 takeaways from the meeting and how they will impact clinical research moving forward.

Blog Post

FDA’s Project Orbis: Trendsetter or One-off

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. Is this the tip of the iceberg for process improvement?

patient-centricity-elephant
Blog Post

Practical Strategies to Simplify Patient Centricity: Part 1—Overview

This is the first in a series of blog posts on putting patient-centric principles into practice. How do you eat an elephant?  One bite at a time, right? Specifically, how do we eat the elephant of patient centricity?  We can employ simple, actionable, “bite-sized” strategies that will move us closer to a more patient-centric approach.