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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?

Kevin Barber
Blog Post

Master Protocols and the New FDA Guidance

In September of 2018, FDA released a new FDA guidance on master protocols. So, what are master protocols, how can they benefit sponsors and patients, and what are the challenges? Kevin Barber shares his thoughts and expertise on the topic.

Blog Post

Collaboration versus Concentration: The Office

The open office concept has gained popularity in recent years, even becoming a sort of corporate status symbol suggesting that a company values openness, collaboration, and innovation. But what does the research show?

Blog Post

Rho Participates in Innovative Graduate Student Workshop for the 8th Consecutive Time

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). 

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Culture Fit Interviews: What Are They and Why Do We Do Them?

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.

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.