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Clinical Trial Information System (CTIS) Updates: Cross-Functional Teams are Needed for Success

Clinical Trial Information System (CTIS) Updates: Cross-Functional Teams are Needed for Success

by Avery Zimmerman | Jan 4, 2023 | Blog

The Clinical Trials Information System (CTIS) is a single portal for European Union (EU) competent authority and ethics submissions for clinical trial applications (CTAs) across EU member states. The system represents the actualization of the EU Clinical Trials...
A Step-by-Step Approach to Determining Company Confidential Information (CCI) in Redaction Proposal Packages

A Step-by-Step Approach to Determining Company Confidential Information (CCI) in Redaction Proposal Packages

by Avery Zimmerman | Nov 30, 2022 | Blog

With all new regulations like Health Canada-PRCI, EMA Policy 0070  and EU-CTR requiring the publication of clinical information, it’s important to understand what is considered company confidential information (CCI) and how to protect the information being shared with...
Conducting Quantitative Risk Assessments for Anonymized Datasets and Documents: What This Means for Sponsors and Patient Privacy

Conducting Quantitative Risk Assessments for Anonymized Datasets and Documents: What This Means for Sponsors and Patient Privacy

by Olivia Grant | Oct 3, 2022 | Blog

CANTON, Mich. (10/2/2022) – Data anonymization and document anonymization in clinical trial data is now more important than ever. In recent years, clinical trial data sharing has become a requirement as part of the regulatory process for EMA and Health Canada. ...
Clinical Trial Information System (CTIS) Updates: Cross-Functional Teams are Needed for Success

How does the European Union Clinical Trial Information System (EU-CTIS) Affect Clinical Trial Transparency?

by Avery Zimmerman | Sep 15, 2022 | Blog

On 31 January 2022, the EU Clinical Trial Regulation 536/2014 (commonly known as EU-CTR) replaced the long-standing directive, the European Union (EU) Clinical Trial Directive 2001/20/EC (commonly known as EU‑CTD). There are important changes in the EU-CTR, compared...
Clinical Trial Disclosures 101: The Basics You Need to Know

Clinical Trial Disclosures 101: The Basics You Need to Know

by Avery Zimmerman | Jul 29, 2022 | Blog

As regulations around clinical trial data disclosure continue to increase in complexity, it can be difficult to keep up with the changes. We asked Raina Agarwal, Associate Director of Clinical Trial Disclosure, to give us a class in Clinical Trials 101 to go over the...
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