Regulatory Insights
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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.
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Realizing Business Benefit And Inspection Readiness With A Solid CAPA Framework
5/8/2024
Embracing proactive quality culture transforms CAPA from a routine task to a continuous improvement tool. Learn how senior management support and robust processes drive excellence.
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Getting The CAPA Framework Right The First Time
5/8/2024
CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.
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How Project Optimus Is Influencing Emerging Biopharma And Biotech
5/7/2024
With expertise in the evolving clinical trial landscape and solutions tailored to individual needs, discover how navigating the challenges of oncology drug development is manageable.
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A Clearer Harmony And Attractiveness For EU Clinical Trials Regulation
5/6/2024
Explore the latest insights on navigating the transition to the EU Clinical Trials Regulation (EU CTR) and ensuring alignment across stakeholders for seamless adaptation in this Pharmaphorum podcast.
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Optimizing CAGT Post-Trial Long-Term Follow-Up
5/6/2024
Uncover how navigating longer study durations presents unique challenges, necessitating efficient data collection methods and flexibility to adapt to evolving patient journeys and regulatory landscapes.
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Shifting The Approach: 4 Strategies For ICH E6(R3) Implementation
4/30/2024
In addition to codifying some best practices, R3 suggests sponsors take a proportionate approach to identifying and managing areas of risk.