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
From the Launchpad
Genomes2People Expands Partnership with SoundRocket to Improve Personal Genome Sequencing Outcomes
After about seven years with Soundrocket, the Genomes2People Research Program has re-upped and expanded the partnership with the help of a new NIH grant for its PeopleSeq Consortium study.
SoundRocket Collaboration Leads to Key Publication on Predispositional Genome Sequencing in Healthy Adults
An article just released today in Genome Medical, and available here to download in its entirety, reports on a groundbreaking study of over 650 individuals who have received whole genome sequencing as a predisposition screening tool.
Decoding FDA DTC Policy in the Genetic Testing Space: The Complete Series
Prefer to read all five posts about the recent FDA Pharmacogenetics Test Report activity at once? We have compiled the full week here into this one post…
Decoding FDA DTC Policy: Part 5 – Final Thoughts
Over the course of this week, we have covered a variety of related topics that arose from the recent FDA activity around direct-to-consumer (DTC) genetic testing. Because this is so new, much is yet unknown, so the best we can do today is speculate. However, we thought we would wrap up today with a few parting ideas to consider…
Decoding FDA DTC Policy: Part 4 – The Physician/Genetic Counselor Perspective
The National Society of Genetic Counselor’s position statement on DTC testing from 2015 states that consumers have the right to make an informed decision on DTC genetic testing. As with other DTC tests based on SNP array technology, it is important that companies offering these tests are very clear when discussing their limitations. For instance, the 23andMe Personal Genome Service…
Decoding FDA DTC Policy: Part 3 – The November 1 Warning Shots
One day following the Personal Genome Service Pharmacogenetic Reports (PGSPR) approval release, on Thursday, November 1, 2018, Jeffrey Shuren, M.D., J.D. (the Director of the FDA’s Center for Devices and Radiological Health), together with Janet Woodcock, M.D., (the Director of the FDA’s Center for Drug Evaluation and Research) published a statement to warn “consumers about genetic tests that claim to predict patient’s responses to specific medications.” This statement specifically calls out tests…





