June 15, 2022
For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside..
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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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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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March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency..
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February 25, 2021
The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory..
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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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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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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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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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