Regulatory Insights
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Enhance Audit Readiness
5/16/2024
Explore how tools like Scout Academy help maintain clinical trial audit readiness by ensuring regulatory compliance, patient safety, and data integrity.
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Raw Material Control For Biotechs (Part 2): Clinical Development Considerations
5/15/2024
Take a deep dive into several strategies being used to enhance raw material control to facilitate successful regulatory submissions and commercialization efforts.
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IRB Review Of Changes To Previously Approved Research
5/15/2024
Learn why understanding the intricacies of IRB review for study changes is essential for researchers and institutions, covering everything from minor amendments to significant modifications, ensuring compliance and participant safety.
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Proposals From The DIA/Harvard-MIT CRS CGT Executive Roundtable
5/15/2024
Gain insight into the critical importance of proactive engagement, collaborative partnerships, and continuous education to navigate these challenges effectively.
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Key Items Auditors Look For When Reviewing An Investigator Site File
5/15/2024
Gain insight on how to prepare investigator site files (ISF) for audits and what teams should consider when looking to enhance efficiency and compliance.
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Navigating Audit Trail Data Regulations And Accessibility Changes
5/15/2024
Data is the single most important thing in a clinical trial. Leverage the power of clinical trial data with effective utilization and access in a changing regulatory landscape.
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How To Improve Site Compliance And Performance
5/14/2024
Creating new drugs or devices profoundly affects health and safety. See why it's vital for clinical research stakeholders — sponsors, CROs, and sites — to work together, meeting rigorous regulatory standards.
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Rare Disease Clinical Research: It Is Time To Tackle What Matters Most To Patients
5/13/2024
Addressing patient needs is crucial in rare disease clinical research. With millions worldwide affected, understanding individual experiences and enhancing patient-centric approaches is vital for progress.
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Examining A Phase 1 COVID-19 Clinical Trial
5/10/2024
Uncover how we were able to efficiently activate the site and enroll 130 participants within six months, demonstrating our expertise in clinical trial management.
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Global Regulatory Excellence Throughout The Clinical Development Lifecycle
5/8/2024
Navigating the intricate global regulatory path is crucial for clinical development success. See how expert-backed support has consistently propelled sponsors toward regulatory excellence.