Industry Insights
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Clinical Trial Logistics: Meeting Unique Participant Needs
2/16/2024
Uncover why delivering a comprehensive service entails establishing a robust global network equipped with the expertise, resources, and adaptability to address diverse participant needs worldwide.
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How To Improve Your Clinical Finance Function
2/16/2024
In the finale of this three-part series on clinical finance, IGM Biosciences Vice President, Financial Planning & Analysis Chris Chan discusses how to leverage the role of clinical finance for clinical trial success.
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FDA’s CBER Issues Final Guidance For CAR T Cell Products
2/15/2024
The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.
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How A Dedicated Medical Affairs Team Drives Site Engagement
2/15/2024
Learn about the improvements made to SIP, which have allowed for quick access to study documents and bulk actions for streamlined document management and enhanced user experience.
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Why Is Clinical Finance Important?
2/15/2024
In part two, IGM Biosciences Vice President, Financial Planning & Analysis Chris Chan explains just how important the role of clinical finance can be in bringing harmony and success into clinical research.
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Why Is Clinical Finance So Challenging?
2/14/2024
IGM Biosciences Vice President, Financial Planning & Analysis Chris Chan explains why the role of clinical finance can be so challenging to define, uphold, and even defend in the world of clinical research.
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Making Rare Disease Progress With Novel Strategies, Data Standardization, And More
2/14/2024
The integration of innovative research methodologies, coupled with the standardization of data and use of advanced visualization techniques, represents a holistic strategy to address the complexities of rare diseases.
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ePROM Implementation: 4 Best Practices For System Functionality
2/13/2024
Explore four of the 15 system functionality considerations highlighted in an eCOA Consortium article that aim to create a more thorough and standardized approach to ePROM implementation.
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Bridging The Gap: Breaking APAC Into The US FDA Market
2/13/2024
For APAC companies, it's important to identify the differences in care standards, formulate strategies for compliance, and develop solutions to bridge the regulatory gap and realize FDA approval.
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Trends In FDA FY2023 Inspection-Based Warning Letters
2/13/2024
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.