June 15, 2022
For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside..
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..
April 13, 2021
There has been an increasing use of digital measures in drug development recently. New wearables technologies can help..
March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency..
February 25, 2021
The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory..
February 24, 2021
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM...
February 11, 2021
The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected..
December 21, 2020
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog..
December 18, 2020
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit..