RESOURCES & PERSPECTIVES
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Optimal COA Measurement Strategy In Modern Oncology Trials: Insights
8/29/2023
Explore the challenges and opportunities in implementing patient-reported outcome measures (PROMs) in oncology trials. This article discusses the recent FDA draft guidance, emphasizing how more targeted PROM strategies could lead to better medication labeling and patient care in cancer treatment.
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EMA Paper Overview: Decentralized Elements In Clinical Trials
8/29/2023
Review a summary of themes highlighted from the recent EMA recommendation paper concerning decentralized components within regulatory submissions for clinical trials.
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What 4 Things Do All eCOA Studies Need To Succeed?
8/8/2023
Learn what else, in addition to good technology, study teams need for eCOA studies to succeed.
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3 Themes And Takeaways From FDA's Draft Guidance On DCTs
8/8/2023
Get our experts’ summary of recent regulatory guidance as well as recommendations for optimal decentralized clinical trial design and conduct.
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Computerized Adaptive Tests Using PROMIS CAT
8/8/2023
Learn how Signant’s unique PROMIS CAT captures high-quality COA data while reducing completion burden.
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Increase Participant Diversity With eClinical Tools
4/14/2023
The right technology and community partnerships can help sponsors meet FDA diversity requirements without additional expenditures, build relationships with minorities, and prepare for future trials.
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Finally, A Unified eClinical Platform With One Login
4/10/2023
Make hybrid and decentralized clinical trials expedient and cost-effective, without time-consuming integrations, lengthy start-up times, or specialized staff with unified eClinical solutions.
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The New Industry Migration Framework For FSP
2/28/2023
Review why a functional service provider should be on the top of a sponsor’s list when it comes to choosing a specialized eClinical data management provider for its next study.
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FDA Guidance Has Implications For EDC And EHR eSource Capabilities
2/28/2023
Gain insight from an eSource study observing digitally received data as far back as 2007 to just before initial guidance was released by the U.S. FDA in 2013.