Our Blog
Blog Post
Age Diversity in Clinical Trials: Addressing the Unmet Need
The fundamental assumption of clinical trials research is that we can take data from a relatively small, representative selection of subjects and generalize the results to the larger patient population. Unfortunately, our industry has long struggled with underrepresentation of important demographic groups, especially women, racial and ethnic minorities, and the elderly.
Blog Post
Site Investigator vs. Sponsor SAE Causality: Are they different?
Causality assessments may differ between the site investigator and sponsor. It is important to understand the difference in assessments to ensure proper reporting and conduct through a trial. To better understand how to handle these situations it’s important to understand the differences.
Blog Post
What We Learned at PhUSE US Connect
The three-day event attracted over 580 data scientists, biostatisticians, statistical programmers, and IT professionals from across the US and around the world to focus on the theme of “Transformative Current and Emerging Best Practices.” Here is a round-up of some of the main themes of the conference and trends for our industry.
Blog Post
Cellular Therapy Studies: 7 Common Challenges
Cellular therapy has become increasingly-popular largely due to the fact that cells have the ability to carry out many complex functions that drugs cannot. When successful, cellular therapy can result in a more targeted and thus more effective treatment.
Blog Post
The Future, Today: Artificial Intelligence Applications for Clinical Research
Artificial Intelligence apps use machine learning algorithms to improve the user experience. Machine learning (ML) algorithms make predictions and, in turn, learn from their own predictions resulting in improved performance over time. What does all this mean for clinical research?
Blog Post
Challenges in Clinical Data Management: Findings from the Tufts CSDD Impact Report
The most recent Impact Report from the Tufts Center for the Study of Drug Development presented the results of a study including nearly 260 sponsor and CRO companies into clinical data management practices and experience. These findings represent the challenges those of us in clinical data management are struggling with given the current state of the clinical research industry and technological changes.
Blog Post
Revised Draft Guidance: Formal Meetings with the FDA for Drug Products
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.
Blog Post
What Makes a SuperheRho: More Than a Coworker in a Cape
“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.
Blog Post
Highlights from TEDMED 2017
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.
Blog Post
50 Must Have Travel Tips from Experienced CRAs
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.