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At Rho, we are proud of our commitment to supporting education and fostering innovative problem-solving for the next generation of scientists, researchers, and statisticians. One way we enjoy promoting innovation is by participating in the annual Industrial Math/Stat Modeling Workshop for Graduate Students (IMSM) hosted by the National Science Foundation-supported Statistical and Applied Mathematical Sciences Institute (SAMSI). 

We believe our employees are our greatest asset.   Attracting and retaining the most talented employees is critical to our success, so we put a huge emphasis on selecting the right people to join us and maintaining a culture where talented people want to stay long-term.

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.

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.

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.

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.

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?

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.

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.