LIVE Webinar - EU Clinical Trial Regulation: Applying CCI best practices to accelerate preparation of CTIS public version documents

A comprehensive review of the EMA guidance regarding CCI, best practices to operationalize and streamline your internal CCI identification and redaction processes including review of specific use cases and examples. This webinar will include audience Q&A.

Thursday, May 18th at 10am

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Disclosure Best Practices: Commercial Confidential/Business Information (CCI/CBI) -Google Ads Landing

A significant portion of initial submissions result in rejection by regulators - CBI redaction content for initial submission packages. CCI/CBI continues to be a critical component to disclosure submissions with regulators, yet, the tendency to over redact remains. This webinar will review internal business considerations, the need for strong collaboration between Disclosure, Legal and Clinical teams and balancing the needs of regulators.

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Date: Thursday, June 23rd, 2022

Time: 10am EST

Patient Voice: The Intersection of Real World Data & Natural Language Processing

Using a categorization model for Social, Emotional, Cognitive, Physical & Functional parameters we will discuss amplifying the patient voice via Natural Language Processing. By sorting through large amounts of data in ways never before possible you will learn how to generate novel insights from Patient Outcomes in Real World Data.

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Date: Wednesday, March 30th

Time: 10am EST

Google Test - Trial Disclosure: A Focus On Rare Diseases

Working with rare disease populations requires compliance strategies be thought through carefully in advance. Small populations, like those found in rare and ultra-rare disease populations can increase the likelihood of patient re-identification if advanced methods are not applied. This webinar session will focus on learnings and best practices to apply when working with rare disease trials and populations.

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Date: Thursday, April 28th

Time: 10:00am EST