Our Blog
Blog Post
Patient-Focused Drug Development: Incorporating the Patient’s and Caregivers’ Perspectives into Product Development
Patient-centricity and family-centricity has been a hot topic for the past few years in clinical research, as more groups in pharmaceutical companies and CROs are working on patient engagement and patient-centric approaches to clinical research programs. Recruitment and retention are one part of patient-centricity, but the more important up-front and overarching aspect of patient-centric research comes from Patient-Focused Drug Development (PFDD).
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?
Blog Post
Risk Evaluation and Mitigation Strategies: FDA Guidances for Assessing Effectiveness
In January 2019, the Food and Drug Administration (FDA) released 2 draft guidance documents regarding assessment of Risk Evaluation and Mitigation Strategies (REMS). . These documents are meant to provide industry additional information to more accurately assess the effectiveness of their REMS.
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
Patient Reported Outcomes and the Common Terminology Criteria for Adverse Events (CTCAE)
The Common Terminology Criteria for Adverse Events (CTCAE) was developed to standardize reporting of adverse events (AEs). In order to integrate the patient’s perspective into AE reporting, the NCI developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Blog Post
Accentuate the. . . Negative: The Importance of Publishing Negative Clinical Study Results
Negativity often gets a bad rap, but not when it comes to scientific research. Jamie Chang discusses how focusing on the negative can bring about positive advances in clinical research.
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).
Blog Post
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.