Adverse Event and Medication Coding Systems

Categorization of adverse events and medications is critical to understanding the safety profile of a therapy. Accurate, consistent coding of medical terminology facilitates statistical analysis and product labeling.

Explore Consulting has designed custom and implemented commercial adverse event and medication coding systems for clinical trial data and spontaneous safety reports.

Not only do we handle the technical design issues for software development and validation, we understand the coding process for clinical trials, data queries, statistical analysis, medical writing, regulatory submission, and synchronization between safety and clinical trial systems. We have in-depth knowledge of the Medical Dictionary for Regulatory Activities (MedDRA) supported by the Maintenance and Support Services Organization (MSSO) (www.meddramsso.org) and World Health Organization Drug Dictionary (WHO-DD) maintained by the Uppsala Monitoring Centre (www.umc-products.com).

To find out more about how Explore Consulting can help, contact us.