Scott D. Crawford

Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension

Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension

by | Sep 9, 2024

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.

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Insights on the FDA’s Virtual Public Meeting: Home as a Health Care Hub Initiative

Insights on the FDA’s Virtual Public Meeting: Home as a Health Care Hub Initiative

by | Aug 27, 2024

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.

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Navigating the New FDA LDT FinalRule with SoundRocket’s Expertise

Navigating the New FDA LDT FinalRule with SoundRocket’s Expertise

by | May 17, 2024

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.

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How Long Should a Survey Questionnaire Be?

How Long Should a Survey Questionnaire Be?

by | Jan 2, 2023

When designing a survey questionnaire, there are guidelines to consider regarding its length, including: 1. The purpose of the survey If the survey is designed to collect detailed information from respondents, it may need to be longer to capture what is needed.  2....

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