…beginning and read about our story. I have certainly enjoyed writing them! I look forward to using the LaunchPad blog to write about and share our experiences. While I expect the…
Results for "our story"
Why Do You Need Campus Climate Surveys?
…welcoming atmosphere for everyone. Campus climate surveys are a critical tool for ensuring all community members feel safe, respected, and valued. A Brief History of Campus Climate Surveys A compelling …
FDA-Compliant Label Comprehension Studies for OTC Drug & Device Clearance
…website—and the individual’s personal health history. Selecting a Representative Study Population Recruiting a demographically diverse and representative study population is critical to ensuring that findings reflect real-world OTC product users….
FDA Risk Analysis for Your Medical Devices: What You Need to Know Now
…everything together. Be sure to tell your risk management story from beginning to end, including how it influenced your device design decisions, the experts you consulted when evaluating the severity…
From Academia to the FDA: How SoundRocket Launched into Regulatory Research
…reports. At the time, we saw this work as part of product development. What we didn’t realize was that it would later play a key role in regulatory history. A…
What to Know About FDA’s Self-Selection Studies Guidance
…analysis. Questions about the participant’s medical history relevant to the decision to use the health product should be asked after completing the self-selection questionnaire. This is so you don’t introduce…
Navigating the New FDA LDT FinalRule with SoundRocket’s Expertise
…Wide Range of Participant Populations Given our academic social science history, there are very few populations with which we have not engaged in a study. However, we specifically have had…
FDA Regulatory Oversight is Shifting for LDTs
…marketed, or sold in volume. They are essential to patient care, helping with diagnosis, monitoring, and treatment plans for various conditions. The history of LDTs & FDA oversight LDTs are…
A Governmental “Source of Public Randomness”
…that person later ends up founding the next Google empire and changes the course of history? Check it out – will these beacons be helpful to you in your work?…
Moving Beyond P Values: A New Era for Supporting Social Science Research
…p value less than 0.05 has traditionally been viewed as ‘significant’, this threshold is somewhat arbitrary and doesn’t convey the full story. But remember, even with a small p value,…