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New FDA Draft Guidance Addresses Data Considerations For Externally Controlled Trials
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Guest Column |
By Mark Durivage, Quality Systems Compliance LLC
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The FDA recently released for public comment Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products. This guidance provides recommendations to sponsors and investigators, addresses considerations for the design and analysis of externally controlled trials, describes considerations related to communicating with the FDA, and ensures access by the FDA to data from an externally controlled trial.
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Reduce Time, Cost, And Risk With Clinical Study Data Review Software
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Case Study |
PerkinElmer Informatics, Inc
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A Top 10 global biopharmaceutical company needed to implement a single clinical study data review system to reduce the time, cost, and risk of running their clinical trials while accelerating the time-to-market. The company deployed PerkinElmer's interactive data visualization and analysis solution, which is quickly becoming the tool of choice for clinicians and safety reviewers.
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The AI Revolution In Multivigilance
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Article |
By Bruce Palsulich, Oracle Health Sciences
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Explore how the life sciences industry is undergoing dynamic change thanks to advances in science and engineering.
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Creating A Successful ML Data Governance Strategy
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Article |
By Pankaj Manon and Christina Dinger, ThoughtSphere
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Thanks to clinical discoveries and technological advancements, the industry has witnessed an unprecedented surge in data. Consider these key principles when developing and implementing machine learning governance policies.
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Patient Over Process: The inSeption Group Difference
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Video |
inSeption Group
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Everything we do is driven to challenge the status quo in the current outsourcing paradigm. inSeption is a home for clients and professionals who have been stifled by mainstream, high-volume, commoditized outsourcing models.
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2023 PDA Advanced Therapy Medicinal Products Conference |
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The 2023 PDA Advanced Therapy Medicinal Products Conference, June 7-8, in Baltimore, MD, will focus on the theme, "Navigating through CMC Challenges." This popular conference will offer a forum for sharing best practices and learning from the experts how the industry is applying novel approaches to a wide variety of topics relating to cell and gene therapies. Register now!
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The Long-Term Impact Of COVID-19 On Monitoring And Other Trial Processes
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Guest Column |
By James Gillespie, Ph.D., JD, MPA, John Whyte, M.D., MPH, and Greg Licholai, M.D., MBA,
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Pandemics provide a massive pressure-test of healthcare systems, allowing us to isolate what works well and what merits improvement. The COVID-19 pandemic is going to create a “new normal” regarding resetting the equilibrium in a variety of policies, procedures, and processes. In Part 1, we examine five factors that more directly impact the clinical trial process and patients.
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You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. To make changes to your newsletter selections, update your topic preferences.
- Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
- Clinical Trial Technology (Tuesday)
- Decentralized Trials | Trial Management (Wednesday)
- Outsourcing Models | Regulatory & Compliance (Thursday)
- Clinical Data Management & Analytics | Trial Monitoring (Friday)
Learn more about our personalized newsletters here.
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