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https://www.cytel.com/blog/in-a-virtual-room-with-the-fda-reviewers
July 30, 2021
I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B..
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https://www.cytel.com/blog/7-steps-to-an-evidence-dossier-for-wearables
April 13, 2021
There has been an increasing use of digital measures in drug development recently. New wearables technologies can help..
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https://www.cytel.com/blog/the-integration-dilemma
March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency..
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https://www.cytel.com/blog/use-of-wearables-in-confirmatory-clinical-trials
February 25, 2021
The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory..
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https://www.cytel.com/blog/avoiding-lost-in-translation-with-submission-terminology
February 24, 2021
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM...
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https://www.cytel.com/blog/wearables-based-clinical-trials-the-biostats-and-clinical-overview-of-a-growing-clinical-development-strategy
February 11, 2021
The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected..
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https://www.cytel.com/blog/year-end-roundup-your-favorite-blog-posts-of-2020
December 21, 2020
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog..
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https://www.cytel.com/blog/submitting-software-programs-to-the-regulatory-agencies-what-should-you-know
December 18, 2020
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit..
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https://www.cytel.com/blog/mapping-the-landscape-of-covid-19-clinical-trials-in-the-us
December 1, 2020
An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread. As..
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