Data Validation in Clinical Data Management
Explore the importance of data validation in clinical trials, from key components & processes to modern techniques & regulatory compliance for reliable outcomes in clinical data management.
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The Role of Data Monitoring Committees (DMC) in Clinical Trials
Explore the crucial role Data Monitoring Committees play in clinical trials, ensuring patient safety, data integrity, and effective study oversight.
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BOIN Design in Early Phase Clinical Trials
Bayesian Optimal Interval (BOIN) design are growing in popularity due to their statistical robustness, practical applicability and simplicity. Learn more.
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The Effects the ICH E6(R3) Updates Will Have on Good Clinical Practice
Discover how the ICH E6(R3) updates will impact Good Clinical Practice, from enhanced ethical standards & patient-centricity to a risk-balanced approach.
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A Guide to CDISC ADaM Standards in 2024
Your guide of everything you need to know about Analysis Data Model (ADaM) standards and datasets in 2024 to ensure a smooth regulatory submission.
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What is Clinical Data Management?
Discover how Clinical Data Management ensures data integrity and regulatory compliance in clinical trials, and deep dive into the roles, stages, and essential skills required.
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Risk-Based Quality Management in Clinical Data Management
Discover how Risk-Based Quality Management (RBQM) optimizes clinical data management for improved safety, efficiency, and regulatory compliance in clinical trials
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The ALCOA+ Principles for Data Integrity In Clinical Trials
The principles outlined in ALCOA and ALCOA+ support data integrity and compliance in clinical trials to ensure a successful regulatory submission.
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A Guide to Creating and Developing a Clinical Data Management Plan
Create an effective Clinical Data Management Plan with our guide. Quanticate offers expert support for Phases I-IV & device trials. Contact us for tailored solutions.
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CDASH Standards and Conformance in Clinical Data Management
Conformance to CDASH is critical in clinical research and data management. Explore common questions and guidance on CDISC's CDASH standards in our latest blog.
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