Experts in social science survey research.
From study design and data collection to analysis and reporting, if you need help with your research study, weโve got you covered.
With loads of experience under our belt and a skilled in-house team, we can help you design and execute high-quality, defensible, survey-based social research studies.ย We specialize in campus climate surveys, FDA human factors studies, social science research, and custom survey services to meet your research needs. Learn more about Co-Pilot, our approach to FDA human factors studies.
Experts in health and science communications
As leading experts in the field, we can help you with FDA regulation compliance through our Co-Pilot process, including health risk user comprehension, label comprehension studies, self-selection studies, simulated use studies, and human factors studies.
Experts in survey methodology and implementation
Take advantage of our expertise in study design, questionnaire design, sample design, sampling, survey development & testing, survey methodology, qualitative research methods (cognitive interview, focus groups, etc.), data collection (all modes and methods), and data reporting for your next research endeavor.
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What to Know About FDA’s Self-Selection Studies Guidance
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: Whatโs 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.
Do Laboratory Developed Tests Now Need Premarket Review and FDA Clearance?
Learn about the FDAโs new regulatory changes for Laboratory Developed Tests (LDTs) and how they impact premarket review and authorization. Explore key takeaways and implications for healthcare providers and innovators
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.