We Design, Do, & Deliver Studies
Founded over twenty years ago, SoundRocket can meet your social science study needs in everything from design and data collection to analysis and reporting.
Your Research Partner in Precision & Execution
Expert project management, clear communication, and scientific rigor—SoundRocket integrates seamlessly with your team to keep studies on track. We specialize in two areas:
Regulatory Studies
SoundRocket specializes in regulatory studies that support successful 510(k) submissions with scientifically sound, defensible research. Call us when you need your next…
- Label Comprehension Study
- Self-Selection Study
- User Comprehension Study
- Human Factors Study
- Actual Use Study
- Simulated Used Study
- ACNU Study
- Consumer Study
- Provider Study
- Custom Study
Academic Studies
SoundRocket partners with researchers to design and execute high-quality social science studies using proven survey methodologies. Bring a Survey Methodologist and expert Survey Manager to your next…
AncestryDNA Factor V Leiden Genetic Health Risk Test
K192944
AncestryDNA Saliva Collection Kit
K192947
AlphaID At Home Genetic Health Risk Service
K221420
FERTI-LILY Conception Cup
K222969
GlutenID Celiac Genetic Health Risk Test
K241456
Select FDA Clearances
We design and implement science-guided, defensible studies that are targeted, rigorous, and led by experts.
We just got clearance from the FDA for the AlphaID At Home Service for OTC use!
USER COMPREHENSION STUDY Genetic Health Risk Test
SoundRocket Customers
SoundRocket has served over 400 institutions and organizations since 2004.
From the Launchpad
Introducing a Specialized CRO for FDA 510(k) Study Needs
Introducing a Specialized CRO for FDA 510(k) Study Needs Bringing a medical device to market requires navigating complex FDA regulatory pathways for medical devices. These pathways—such as premarket notification (510(k)), premarket approval (PMA), and De Novo...
FAQs about the FDA’s Final Rule on ACNU for Nonprescription Drugs
What is ACNU? ACNU stands for "Additional Condition for Nonprescription Use," a regulatory framework introduced by the U.S. Food and Drug Administration (FDA) to make certain medications available over-the-counter (OTC) while ensuring they are safe and effective for...
Navigating the FDA’s Final Rule on ACNU for Nonprescription Drugs
Key Areas of Focus for Manufacturers Under the New Guidelines FDA self-selection studies are critical to the regulatory evaluation process, particularly for over-the-counter (OTC) drugs and direct-to-consumer (DTC) The FDA has recently finalized a rule about...
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.