Perspectives on Enquiry & Evidence

Cytel's blog featuring the latest industry insights.

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Aligning Clinical Trial Design with Investment Priorities

When working with investors, it’s critical that drug and device developers consider how their clinical trial design aligns with investment priorities. Natalia Muehlemann and Ari Brettman (Blackstone Life Sciences) discuss what investors look for when evaluating clinical development programs, and the value of simulation-guided design in informing decisions and facilitating communication with investors.

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Perspectives on Enquiry and Evidence

December 18, 2020

Submitting Software Programs to the Regulatory Agencies

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

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July 28, 2020

Therapeutic Area User Guidance – The hidden Gems

CDISC standards have been around for a while with the first SDTM Standard version released in 2004. However, it was...

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April 27, 2020

Highlights from the 2020 Virtual CDISC EU Interchange - Part 2

In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC...

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April 24, 2020

Highlights from the 2020 Virtual CDISC EU Interchange by Angelo Tinazzi

In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C)...

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May 12, 2016

Lost in Traceability- From SDTM to ADaM

Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home. Their...

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