Clinical Guest Contributors
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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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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.
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Addressing Underrepresentation In Cancer Trials: A Q&A With Stand Up To Cancer & Triage Cancer
2/13/2024
Clinical Leader heard from both sides of the collaboration — SU2C researcher Dr. Chanita Hughes-Halbert, Ph.D., and grant recipient Triage Cancer co-founder and COO Monica Fawzy Bryant, Esq. — to explore each’s efforts to together bring health equity to those diagnosed with cancer.
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Strategies For Seeking Multiregional Regulatory Approval
2/12/2024
Consultant Peter Embley discusses the importance of developing a regulatory strategy (RS) that intends to support both U.S. and EU regulatory approval.
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FDA Guidance On Standardizing Diversity And Inclusion Terminology And Collection
2/9/2024
Last week, the FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.
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9 Ways Unified Clinical Data Cloud Platforms Solve Data Challenges In Rare Disease
2/8/2024
A unified clinical data cloud platform is a data and analytics platform that contains a data hub to aggregate clinical data from multiple data sources and in multiple formats — and it could be the cure for disordered rare disease data.
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Transforming Clinical Trials For Women In 2024
2/7/2024
Change is long overdue, and it begins with a fundamental shift in how we design clinical trials, placing women's perspectives and needs at the core of planning and implementation.
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3 Areas Where AI Could Revolutionize Patient Recruitment And Retention
2/6/2024
Explore three ways in which AI can make a positive impact on patient recruitment and retention, as identified by life sciences consultant Ross Jackson.