Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to define the process for incorporating Quality by Design (QbD) principles into clinical trial planning, conduct, and oversight. It ensures compliance with ICH E8(R1), focusing on study quality by integrating risk-based approaches and identifying critical-to-quality (CtQ) factors that safeguard participant safety and data reliability.
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The purpose of this SOP is to establish standardized procedures for the design, conduct, and oversight of Multi-Regional Clinical Trials (MRCTs) in accordance with ICH E17 guidelines. MRCTs are critical for generating data acceptable across multiple regions, facilitating simultaneous regulatory submissions, and ensuring diversity and representativeness in study populations.
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The purpose of this SOP is to establish a standardized framework for managing safety data in clinical trials in alignment with ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), E2B(R3) (Electronic Transmission of Individual Case Safety Reports), and E2F (Development Safety Update Report – DSUR) requirements. This ensures accurate and timely adverse event reporting to regulatory authorities, ethics committees, and global PV databases.
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The purpose of this SOP is to provide guidance for the application of statistical principles in clinical trials in accordance with ICH E9 and E9(R1). It defines processes for developing statistical analysis plans, handling deviations, applying the estimand framework, and ensuring robust data interpretation that supports regulatory submissions and scientific validity.
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The purpose of this SOP is to establish processes for selective safety data collection in clinical trials, in alignment with ICH E19. This approach ensures optimization of safety data collection where comprehensive data are not required, while maintaining subject protection, regulatory compliance, and integrity of safety evaluation.
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The purpose of this SOP is to define processes for managing QT/QTc signals in clinical trials in alignment with ICH E14. QT prolongation poses significant cardiac risks, and proper signal detection and management are essential for ensuring subject safety and meeting regulatory obligations.
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