Regulations & Compliance STREAM

  1. 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.

  2. 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.

  3. Taking A Risk-Based Approach To An Inspection-Ready Audit Trail 2/10/2021

    Regulatory agencies agree that a risk-based approach is the best way to ensure quality in clinical trials. But knowing how to implement such a process can be daunting. In this session, we will explore how to implement RBM to ensure your TMF Audit Trail is ready for inspection.

  4. 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.

  5. psiXchange: Intelligent, Automated Safety Reporting 3/25/2024

    Say goodbye to manual burdens and embrace efficiency by fully automating your safety reporting. This will significantly cut down on effort and costs, all while enhancing compliance standards.

  6. An Overview Of Health Canada's CTA Process 10/24/2023

    Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.

  7. Tackling The EU CTR Compliance Challenge 10/4/2018

    Maintaining disclosure compliance is tricky enough with ClinicalTrials.gov, but when it comes to EU CTR compliance, the complexity rises to a whole new level. As a sponsor, do you find your organization “guilty” of these common errors?

  8. An Innovative Approach To Trial Results Summaries 12/3/2019

    See how sponsors are employing technology to replace outdated, paper-based patient communications about trial results. This innovative approach enables clinical trial sponsors to meet their ethical obligations to trial participants while simultaneously increasing patient engagement.

  9. Evaluating Abuse Potential Of CNS-Active Drugs For EU And US Submissions 1/30/2023

    Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.

  10. Plain Language Summaries Becoming A Mandate Worldwide 6/13/2024

    A growing number of countries are requiring clinical trial protocol and results disclosures to be written in plain language, influencing how these documents are authored.