The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Wearables-based Clinical Trials: The biostats and clinical overview of a growing clinical development strategy

February 11, 2021

The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected changes to the industry ushered in by the COVID-19 pandemic has highlighted the need for remote monitoring and patient-centric outcomes and accelerated the changes in the trials conduct.

Below we identify six elements critical to integrating wearables into your clinical development program.

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Highlights from the 2020 Virtual CDISC EU Interchange by Angelo Tinazzi - Part 2

April 27, 2020

In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC converted our physical event into a virtual one and was held on April 1-2, 2020. I provided a summary of the updates received from the three main health authorities - the US FDA, the Japanese PMDA and the European EMA.

This post offers an overview of the other sessions I attended at the 2020 Virtual CDISC EU Interchange. The agenda was well planned and organized. The distinguished speakers were extremely prepared and answered numerous questions after their presentations. Continue reading for further highlights from the event.

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Highlights from the 2020 Virtual CDISC EU Interchange by Angelo Tinazzi

April 24, 2020

In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C) together with CDISC decided to cancel our physical event in Berlin, planned for April 1-2, 2020. It was a tough decision, but unavoidable and necessary.

We did not let this dampen our spirits and immediately came up with an alternative plan – go virtual with the event! In only two weeks the team managed to pull together a revised program and the registrations were opened on the CDISC website. The scale of the event went from being Europe-only to Global, and around 300 people attended it worldwide. In the end, the event was a hit. Everything worked out very well, with no major technical disruptions and the speakers respecting the allocated time slots.

In this two-part blog post, I share a summary of the sessions I was able to attend, while simultaneously ensuring business continuity for my regular projects.

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Lost in Traceability- From SDTM to ADaM

May 12, 2016

 

Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home.  Their story can be an allegory for the concept of traceability in clinical data where we need to  lay a clear path to ensure that the results we have created can be reproduced. This blog looks at some aspects of a presentation Lost in Traceability  by Angelo Tinazzi at the CDISC EU Interchange. 

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5 Hot Topics from the CDISC EU Interchange

May 4, 2016

Last week was the CDISC EU Interchange conference in Vienna, a key event on the calendar for Cytel’s statistical programming subject matter experts . Angelo Tinazzi, Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel co-chaired the sessions on Foundational Standards and Standards Governance alongside Astrazeneca’s Daniel Graham, and delivered a presentation on Traceability within the Foundational standards track.

In this blog, Angelo highlights some of the hot topics which emerged from the presentations he attended during the meeting. 

 

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