Insights on Clinical Trials
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Advancing From Single Country Phase 1 Success To Multinational Phase 1/2 Trial
1/3/2024
Explore how this partnership aims to contribute to the success of the trial by leveraging global resources and streamlining processes for efficient and timely results.
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HIV – Global Clinical Trial Landscape
1/3/2024
Get a comprehensive overview of the global HIV clinical trial landscape since 2018, showcasing regional leadership, trial phases, and growth rates.
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High-Velocity Development: Gene Therapy Vs. Small Molecule
12/26/2023
Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.
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Protocol Designs That Maximize The Value Of Hybrid Clinical Trials
12/21/2023
Sponsors can maximize the value of hybrid clinical trials by prioritizing patient experience in trial design, balancing technologies with in-home care, site visits, and more to achieve the right design.
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Cell & Gene: The Podcast Episodes From ARM’s 2023 MOTM
12/21/2023
All three episodes of Cell & Gene: The Podcast recorded at ARM's 2023 Meeting on the Mesa have now aired. Here's a look at my guests and the important CGT topics we discussed.
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WHO’s 6 Principles For An AI Regulatory Framework For Medical Product Development
12/14/2023
In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.
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How Automation Improves Safety And Efficacy Of Source Material Collection
12/13/2023
Implementing more automated workflows in cell therapy manufacturing can serve to minimize open processes and manual touchpoints, increasing reproducibility and improving traceability.
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Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement
12/12/2023
The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.
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In Focus: The C Of CDMO
12/11/2023
Delve into the intricacies of a successful CDMO relationship and learn how a collaborative approach built on shared goals and open communication can maximize the potential of your cell therapy program.
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2024: The Year Of EHR eSource In Clinical Trials
12/8/2023
Discover the power of EHR eSource in 2024—unlock 10 compelling reasons to elevate your approach and enhance clinical research outcomes.