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On 29 December 2017, the FDA released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.”  This draft guidance replaces the previous draft guidance posted in 2015 on this topic.  According to the draft guidance, from this point in time there will be 4 types of formal meetings with FDA staff. Read more to get the details on each one.

“Who’s your favorite superhero?” Regardless of who you choose the idea behind it is the same: who is someone you look up to, someone who can do anything incredibly. What we often forget is that we actually have superheroes around us every day, in real life—and at Rho.

After attending TEDMED 2017, we wanted to share highlights of the themes that were most interesting to us. Check out our summaries on Understanding the Brain, Delivering Healthcare on the Frontlines, The Opioid Crisis and The Hive.

Clinical Team Leads Caitlin Hirschman and Jamie Christensen, who have a combined 25 years of monitoring experience, share travel tips they’ve acquired over the years.

To meet or not to meet? Meetings don’t have to be a source of frustration or disruption.  To the contrary, meetings can be some of the most productive times of our day – where we solve problems, brainstorm, and find creative inspiration – provided we execute them properly.

Here are some resume and CV tips to help you stand out with the recruiters, hiring managers, and interview teams that make the difference between getting an interview or a rejection letter for the clinical research job you really want.

Whether you plan to file a new drug application (NDA), a biologics license application (BLA), or a premarket approval application (PMA) with the FDA or a marketing authorization application (MAA) with the European Medicines Agency, you’ll need an in depth understanding of how the data you have from your clinical studies, nonclinical studies, and Chemistry, Manufacturing and Controls (CMC) / Quality development map to the requirements of the application.

“How much does a clinical trial cost?” This is a question we frequently get in some form from Sponsors in early phases of development that are trying to figure out what it will cost to hire a CRO to conduct their clinical trials and associated regulatory activities. While the high degree in variability between trials would make it difficult to provide a single answer, we can explain what factors can drive costs up or down.

Preparing a database for lock can be a burdensome process and requires coordinated effort from an entire clinical study team. The team must work together to ensure the accuracy and reliability of the data, but with so many sites, subjects, visits, case report forms (CRFs), and data points it can be difficult to stay on top of the entire process.

Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success.  The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.