FDA self-selection studies are critical to the regulatory evaluation process, particularly for over-the-counter (OTC) drugs and direct-to-consumer (DTC) medical devices. These studies evaluate whether typical users can accurately choose if a health product is right...
Understanding LDTs with Real-World Examples
Laboratory Developed Tests (LDTs) have become an essential part of healthcare diagnostics. These specialized tests, developed and processed within CLIA-certified laboratories, offer customized solutions that help close diagnostic gaps left by commercial options. They are particularly important in areas where traditional diagnostics fall short, such as personalized healthcare.
Advancing LGBTQIA+ Representation: The FDA’s Role in Inclusive Diversity in Clinical Trials
Inclusive clinical trials are essential for ensuring that new treatments and medical interventions benefit all populations, particularly those historically underrepresented in research. By addressing barriers such as non-inclusive screening processes and lack of awareness in LGBTQIA+ communities, the FDA is making strides toward more diverse and representative clinical trial cohorts. This commitment to inclusivity will help create safer, more effective treatments that reflect the needs of all individuals, regardless of gender identity or sexual orientation.
Understanding Response Rate vs. Completion Rate: What’s the Difference?
This article will explain the difference between response rate and completion rate, why each matters, and how both can impact the overall data quality of your survey.
How Patient Preferences Shape Medical Device Development: Insights from FDA Draft Guidance
Explore how Patient Preference Information (PPI) impacts medical device development and regulatory submissions, with insights from the FDA’s draft guidance and key benefits for manufacturers.
Campus Climate Survey Examples in Higher Education: Case Studies and Outcomes
Ensuring a positive campus experience for all students requires understanding each university’s campus climate – an essential part of guaranteeing a school’s sustainability for faculty and students alike. A campus climate survey is an excellent resource designed to...
Example Campus Climate Survey Questions for Higher Education
Universities looking to achieve diversity objectives often implement campus climate surveys to assess student and faculty life and comfort. A campus climate survey measures how students, faculty, and staff feel supported within a university environment regardless of...
Moving Beyond P Values: A New Era for Supporting Social Science Research
[Estimated Reading Time: 3-4 min] At SoundRocket, we often hear from our research partners who want to include p values in their summary databooks. These numbers have long been a staple in not just social science research but in many scientific inquiries. However, the...
What Are Campus Climate Surveys & How Do They Benefit Your Institution?
Campus climate surveys are powerful tools that help colleges and universities gauge campus environment. These surveys provide valuable insight into various aspects of campus life — everything from inclusivity to safety, and play a crucial role in shaping a welcoming...