Accurate MedDRA coding is essential in clinical trials to ensure that safety and efficacy data are properly categorized for statistical analysis. MedDRA (Medical Dictionary for Regulatory Activities) is the global industry-standard dictionary used for the classification of adverse event data, and precise coding is critical for the correct interpretation of clinical trial results.
At ClinBAY, we leverage advanced technology to streamline the MedDRA coding process while maintaining the highest level of accuracy and reliability. Our innovative AI tool, SafeTerm, automates the initial coding by using sophisticated algorithms to efficiently match medical terms with the appropriate MedDRA codes. This significantly speeds up the coding process and reduces the manual workload, saving time, reducing customer costs and improving efficiency.
However, AI is not a complete replacement for human expertise. We understand that the ideal approach combines the strengths of both AI and human coders. SafeTerm handles routine tasks, allowing human coders to focus on complex cases and oversee overall accuracy. Every coding decision made by SafeTerm is reviewed and validated by a MedDRA coder to ensure that the final coding is accurate and fully compliant with regulatory requirements. Human oversight is critical in addressing ambiguous cases and maintaining the integrity of the data.
Additionally, we stay aligned with MedDRA’s frequent updates by ensuring that our coding processes are fully adaptable to the latest dictionary versions. Our services also include validation of externally coded data, where both AI and human review work together to check and verify the accuracy of previously coded data, and updates from older MedDRA versions to a desired version using a combination of AI and human reviewer.
With this AI-human hybrid approach, sponsors benefit from faster turnaround times without compromising on the quality and precision of the coded data. This method allows for streamlined workflows, efficient handling of large data volumes, and the confidence that each coding is thoroughly validated by experienced professionals.
Why MedDRA Coding Matters in Clinical Trials
Proper MedDRA coding is fundamental to clinical data analysis. Accurate and consistent coding ensures that adverse event (AE) data is categorized uniformly, which is crucial for safety assessments, regulatory submissions, and the overall interpretation of clinical trial outcomes.
Well-executed coding is essential to help statisticians and clinical teams maintain data integrity by ensuring that no safety signals are lost due to incorrect or inconsistent categorization. If adverse events are not properly coded, statistical analysis may miss critical safety signals, leading to delays, misinterpretation of data, or even jeopardizing the success of the trial.
By choosing our MedDRA coding services, you ensure that your clinical trial data is not only ready for statistical analysis and submission but also meets the highest standards of precision and reliability.
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