Perspectives on Enquiry & Evidence

For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside..

I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B..

There has been an increasing use of digital measures in drug development recently. New wearables technologies can help..

As of today, our Industry has not defined any approach, nor does an official regulatory agency..

The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory..

In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM...

The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected..

2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog..

Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit..