INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
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Preparing Now For FDA’s START Program For Rare Disease Drug Developers
Delve into this overview of the START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.
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Bringing In Vitro Diagnostics To Market With Real-World Evidence
Explore the potential of real-world evidence in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.
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Key Insights From The FDA's DHT Guidance
Check out a summary of the FDA’s guidance Framework for the Use of DHTs in Clinical Trials and what it means for sponsors and investigators using these innovative tools.
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PV Solutions Optimizing End-To-End Safety In Clinical Development
Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.
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How Sponsors And Sites Work Together To Improve Protocol Compliance3/5/2024
Learn about strategies aimed to reduce protocol deviations and enhance compliance and quality. By implementing such measures, clinical trial teams can streamline operations and minimize the risk of regulatory issues.
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How To Improve Your Site Compliance And Performance3/5/2024
Delve into site and protocol violations to gain insights on how to assist sites in enhancing their compliance without adding undue burdens that could affect critical timelines.
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5 Broad Implications For FDA’s Project Optimus3/1/2024
While formal guidance on the reform the dose optimization and dose selection is still pending, review five common themes that could help sponsors prepare for these changes.
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The Write Side Of AI: Helping Hands, Not Replacement Plans3/1/2024
AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.
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The Importance Of Diversity In Clinical Trials3/1/2024
Diversity in clinical trials is vital for advancing research and ensuring equitable care. Explore the significance of diversity, the DEPICT Act's role, and collaborative efforts to foster inclusivity.
CLINICAL TRIAL REGULATORY SOLUTIONS
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See why TrialScope Disclose is trusted by 16 of the top 20 industry clinical trial sponsors for optimizing, streamlining, and simplifying the clinical trial disclosure process from registration to results.
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Uncover how these regulatory and partner/outsource services are invaluable for biopharma innovators in navigating the U.S. FDA regulatory process.
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IQVIA offers a complete approach that combines safety, regulatory, quality, and medical information to transform and sustain compliance.
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Advancing biologics from start to finish is highly complex and full of challenges, requiring scientific strategies and implementation.
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Applying experience, knowledge, and insights to plan and implement regulatory strategies for successful interactions with the FDA, MHRA, EMA, and other Global Regulatory Agencies.
REGULATORY MULTIMEDIA
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Avance Clinical Expands Pharmaceutical Safety Services With Oracle Argus
Find out what happened after this contract research organization turned to Oracle Argus for compliant clinical trial management.
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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.
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Practical Applications Of ICH E6(R3): What Do We Need To DO?
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
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EU CTR: An Introduction To European Clinical Trial Transparency
Listen in as regulatory expert Pierre-Frederic Omnes takes viewers through an overview of the European Clinical Trial Regulation (EU CTR) and its impact on clinical trials.
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Navigating The Unique Attributes Of Psychedelic Drug Development
This session gives an overview of the recently published draft FDA guidance on psychedelics and how to efficiently adapt the recommendations for early phase clinical development.
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Meeting Diversity Goals Through Smart Trial Design Strategies
Delve into strategies for effectively monitoring and reporting progress toward achieving patient diversity objectives.
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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.
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The Advantages Of Conducting Early Phase Trials In North America
In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.
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Big Changes Ahead For IRBs Regarding DCTs
After reviewing the new FDA Guidance on DCTs, Dr. Daniel Fox, founder and CEO of the Clinical Research Payment Network (CRPN), predicts that IRBs are going to have their hands full in the future when it comes to the acceptance and adoption of DCTs.
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Overcoming Financial Toxicity In Oncology Clinical Trials
Review the historical struggles of oncology research due to financial toxicity, what industry initiatives are breaking barriers, and ongoing D.C. advocacy for lower patient stipend taxes.