Industry Insights
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A Guide To RTSM For Clinical Trials
4/15/2024
Looking ahead, the evolution of RTSM in clinical trials points towards cloud-based solutions, heightened emphasis on patient safety, and greater collaboration among stakeholders. Learn how you can prepare.
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Should You Bring Your Trial Master File In-House?
4/15/2024
The decision to bring the TMF in-house or contract with a CRO depends on the specific needs and resources of the sponsor, and it is important to carefully consider the implications before making a decision.
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FDA’s Updated Draft Guidance On Reporting Of Diversity Data
4/15/2024
To ensure the safety and effectiveness of medical products for different populations, learn how the FDA is standardizing data collection and reporting for all new clinical trials and studies.
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Next Generation Of Clinical Monitoring | Part 2: Detecting Clinical Trial Fraud & Misconduct
4/15/2024
Discover how modern data and surveillance technologies revolutionize the detection of clinical trial fraud and misconduct in the evolving landscape of clinical monitoring.
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Looking Back & Moving Forward With J&J’s Global Development Leader For Immunology
4/15/2024
In this Q&A, David Gordon, M.B., Ch.B. recounts lessons learned from past clinical trial challenges and shares current-day strategies, like figuring out how to run a study that’s both scientifically sound and actually doable for patients and doctors.
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Mission: Remission — Patient Need For Durable Treatment Informs J&J’s Ulcerative Colitis Trial
4/15/2024
J&J Global Therapeutic Area Head, Immunology, David M. Lee, MD, Ph.D., talks about the progression from treating PsO and PsA to UC, the importance of integrating patient needs into the trial’s design, and the quest for a durable treatment that lends itself to total remission.
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EMA’S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation
4/12/2024
As the EU prepares to implement the new eCTD 4.0 standard for regulatory submissions, the European Medicines Agency (EMA) is taking steps to ensure a smooth transition for industry.
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Key Takeaways From The ISPE Ireland Annex 1 Event
4/12/2024
Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.
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FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions
4/11/2024
The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.
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Future Clinical Trials: Embracing Standardization And Automation
4/10/2024
Through standardized protocols and automation integration, uncover how the industry is poised to unlock new levels of productivity and innovation, advancing the development of safe and effective treatments for patients worldwide.