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.
Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension
At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.
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...
Why Do You Need Campus Climate Surveys?
Many universities and colleges conduct regular campus climate surveys. But some may wonder, what insights do they truly bring? Can they actually be used to make higher education institutions a better place? In our experience, when done well, campus climate...
Demographic Questions: Finding the Right Place in Your Survey
Demographic questions are often necessary to include in survey research. Here we visit the age-old question–where in the survey should they go? Recently a collaborator designing a survey for an academic research study asked if it...
When I Asked ChatGPT About AI & Survey Research
The essay linked below was written almost exclusively by ChatGPT based on a series of requests and feedback I provided as the essay evolved. I was looking to understand better what may be the potential impact of emerging artificial intelligence (AI) technologies on...
ChatGPT—Could There Be an AI Survey Methodologist?
When I first heard about the new artificial intelligence (AI) chat tool called ChatGPT (created and offered as a free research tool by OpenAI), I was excited to play with it. Social media was abuzz with others in professional fields who had identified ways that this...