PSI has applied the insight and expertise we have gained from working with the FDA to our clients' advantage. PSI has been intimately involved with and has assisted numerous pharmas in addressing their MedDRA and WHO-DD issues. Since 1998, our activities and contributions to the various MedDRA and WHO-DD communities have included:
Performing a needs assessment culminating in a complete MedDRA implementation strategy
Creating a detailed plan outlining the task timelines and resource assignments necessary for the implementation of MedDRA
Managing the MedDRA implementation process
Providing organization-wide MedDRA training support, including conventional hands-on training, train-the-trainer techniques, computer-based training (CBT) and e-Cert Solution, an innovative computerized certification program based on a mentor-protégé relationship
Coding over 1.3 million individual safety reports and over 13 million verbatims from Adverse Event, Indication and Medical History files to MedDRA
Creating corporate specific MedDRA coding guidelines which reflect the company's individual coding philosophy in compliance with the ICH MedDRA Term Selection: Points to Consider document
Creating a validation plan for tools, software, and newly created processes in association with MedDRA implementation
Providing Data exploration, retrieval and analysis support through training and consulting on strategies/queries for signal detection and analysis process
Providing WHO-DD coding support, coding guideline development and organization-wide training
References are available upon request
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