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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November 23, 2020

Data Standards and Submission Highlights from PHUSE EU CONNECT 2020

The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all...

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October 28, 2020

When your ADaM package is not traceable back to SDTM

About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO...

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September 14, 2020

From Before to After: Preparing and Concluding your FDA Data Submission

“A good start is half the battle” (the Before) when submitting data to the FDA and there are a couple of cherries to...

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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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