REGULATIONS & COMPLIANCE
Taking A Risk-Based Approach To An Inspection-Ready Audit Trail
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 inspec...
psiXchange: Intelligent, Automated Safety Reporting
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.
An Overview Of Health Canada's CTA Process
Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.
Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence
Watch this exploration of real-world case studies of companies utilizing intelligent process automation and embedded, regularly updated safety reporting regulatory intelligence of psiXchange software.
Driving Product Launch Success In Europe
Explore key steps for preparing your medicinal product for the European market, including insights on challenges, timelines, and a success story.
AI In Action: Transforming Clinical Trials
Tala Fakhouri, associate director for data science and ai policy at the FDA, along with industry consultant Elena “Ella” Sinclair of FlexPoint Bio, talk about common applications of AI in clinical development and the new AI-focused regulatory Guidance from the...
How ICH Oversight And AI Are Shaping The Future Of Clinical Trials
Explore how the new ICH E6 (R3) revisions are reshaping clinical trial oversight and examine how AI-driven tools like the Clinical Decision Suite can help sponsors enhance trial efficiency.
Navigating Special Regulatory Pathways For Advanced Therapy Development Success
Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.
Think Canada: The Team Behind Your Clinical Trials
Altasciences has a bioanalytical and clinical facility in Canada. In this video, we unveil the advantages of conducting trials in Canada while introducing some of the faces that work behind the scenes on your studies.
Addressing Opportunities And Challenges In Digital Health Data
Experts from diverse industry sectors unpack key points from the FDA’s final guidance on Digital Health Technologies (DHT) for remote data collection in clinical investigations.
Accelerating Clinical Data Review With Traceable Workflows
Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.
Risk-Based Quality Review: Inside Out
Walk through how to manage and resolve the often conflicting internal and external directives to find the right path for you.
TMF SUMMER SHORTS: House Of The Inspector
Discover key steps you can take to not just survive an inspection, but take the TMF Throne.
Should Sponsors Provide Source Document Templates?
Here, we debate sponsor-provided source document templates, weighing regulatory guidance, compliance risks, and operational impacts for smarter clinical trial documentation decisions.
Achieving Regulatory Compliance With A Unified Immunogenicity Strategy
This presentation equips viewers with the knowledge and tools needed to navigate the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations.
Plain Language Summaries Becoming A Mandate Worldwide
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.
TrialScope Intelligence
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.
Managing A Continually Evolving Disclosure Landscape
Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.
What Should You Ask The FDA About AI
Understanding what some of the common questions the FDA gets about AI may help you as you plan to interact with the agency.
The Many Facets Of Early Phase Evaluation Of Psychedelics In Psychiatry
Altasciences and Sygnature Discovery discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs.
Exploring The Principles Integral To Rare Disease Drug Development
This on-demand webinar offers valuable insights into successful rare disease drug development, including study design, regulatory engagement, and market access strategy.
Accelerate Time To Target Endpoint In Cardiometabolic Studies Using Patient-Centered Technology Solutions
In this webinar, industry experts share their perspectives on how to address drug development challenges within cardiometabolic clinical studies and provide input on the impact of new regulatory guidance such as the DEPICT Act.
PLS Perspectives: Sponsor, Author & Regulatory Viewpoints
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 ...
Ensure Regulatory Success With Support From Your IRT Partner
In this presentation, you’ll get recommendations to help you stay inspection-ready and learn about the importance of clear roles, audit trails, data integrity, and training.
Reporting To ClinicalTrials.gov: Reflections And Challenges
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.
Navigating The Unique Attributes Of Psychedelic Drug Development
Join our panel of experts for an in-depth review of the FDA's guidance on psychedelic drug development, exploring necessary methodological adaptations for safety, pharmacology, and efficacy.
Unlock The Secrets Of Managing CTR In A Complex Development Landscape
Lost in the CTR maze? Watch this webinar to get your burning questions answered by industry experts. Ask about vendor coordination, CTIS integration, and EU strategies.
Strategies For Research Institutions In An Evolving Era Of Oncology
As biomarker-directed therapies drive advancements in the oncology space, experts are reviewing cutting-edge trends and strategies that help institutions address ethical and regulatory challenges.
How Standardized Terminology Can Accelerate Global Regulatory Performance
Watch this panel of regulatory experts taking part in an interactive roundtable examining the benefits of establishing standard terminology and its potential to help significantly improve regulatory quality, data accuracy, and efficiency.
An Innovative Approach To Trial Results Summaries
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 ...