Regulations & Compliance STREAM
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TrialScope Intelligence
7/16/2024
This easy-to-use platform reduces the risk of clinical trial disclosure noncompliance by tracking global disclosure regulations for you. Browse comprehensive regulatory authority and trial registry requirements.
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Beyond First Impressions: CTIS Lessons Learned In First 3 Months
5/19/2022
Now that the EU’s Clinical Trials Information System (CTIS) is up and running, disclosure and transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KgaA discuss the ins and outs of registering clinical trials and submitting study information to the portal.
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Quality Checks Vs. Quality Review
8/22/2023
Watch this presentation where speakers share how teams can improve inspection readiness and reduce potential regulatory risks that could negatively impact operational activities.
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Navigating Early Phase CNS-Active Drug Development
2/14/2023
Early development of CNS-active drugs requires in-depth clinical expertise. Altasciences’ Dr. Beatrice Setnik, Chief Scientific Officer, examines the strategies to ensure early comprehensive data collection to fulfill regulatory requirements and aid in evaluating the risk/benefit profile.
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PLS Perspectives: Sponsor, Author & Regulatory Viewpoints
2/24/2020
In this informative webinar, Jazz Pharmaceuticals will provide tips on launching a PLS program. A medical writer from ClaritiDox will give an overview of PLS best practices. And TrialScope’s chief strategy officer will share – and analyze – results from TrialScope’s recent PLS survey.
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Illuminating IHC: Right-Sizing Your Validation And Regulatory Strategy
5/2/2025
In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).
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Reporting To ClinicalTrials.gov: Reflections And Challenges
11/7/2019
Who can reflect better on this topic than Dr. Deborah Zarin, former director of ClinicalTrials.gov? Dr. Zarin, now with the MRCT Center, shared her experiences and advice at the recent EXTRA: TrialScope Transparency Experience.
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How To Take Advantage Of Early Access Programs For The EU
6/12/2024
Learn how to leverage Early Access Programs (EAPs) in the EU to expedite market entry for innovative life science products. Gain insights into running successful EAPs, including crucial steps for France.
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The Many Facets Of Early Phase Evaluation Of Psychedelics In Psychiatry
2/3/2023
Altasciences and Sygnature Discovery discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs.
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Moving In Unison: Proprietary Scheduling Platform
6/18/2024
Join us for an exclusive discussion that uncovers the science behind our efficient management of key sponsor deliverables and critical milestones, driving our projects to success.