Regulatory Insights
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Reporting To The IRB: Investigator Noncompliance
4/19/2024
Reporting noncompliance concerns is crucial to protect research participants. By promptly reporting noncompliance, researchers can ensure ethical research conduct and protect the rights and welfare of participants.
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Understanding FDA’s 2024 Draft Guidance On DMCs
4/19/2024
By integrating independent Data Monitoring Committees into trial management processes, learn how sponsors can enhance trust, integrity, and the success of their clinical trials.
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The Value Of Continuity: Program-Level DSMBs
4/19/2024
Discover the strategic benefits of deploying consistent DSMB members across therapeutic programs, highlighting the pivotal role of program-level supervision in safeguarding the safety and effectiveness of novel treatments.
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When QuickBooks Leaves Your Life Sciences Venture Struggling
4/18/2024
Is QuickBooks keeping pace with your life sciences venture? Learn the signs it's time to move beyond and adopt tailored solutions for growth, compliance, collaboration, security, and automation.
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Clinical Research As A Delicate Ecosystem
4/18/2024
Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.
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Diversity And Inclusion In Oncology Clinical Trials
4/17/2024
Despite challenges, learn how sponsors can implement diversity plans to enroll and retain clinically relevant participants, including minorities, older patients, and those with disabilities.
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Success Planning For An Original NDA/BLA Submission
4/15/2024
Experts in regulatory strategy, operations, and program leadership provide strategies for initiation triggers, team coordination, submission processes, and Electronic Submission Gateway (ESG).
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2024 MedTech Regulatory Updates: 4 Areas Of Interest
4/15/2024
In 2024, McKinsey's projections foresee a promising year for the MedTech industry, driven by innovation but shadowed by regulatory uncertainty.
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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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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.