History:

Achieving MedDRA coding accuracy, specificity, and overall consistency presents quite a challenge to every organization. These are the essential qualities of every MedDRA coded dataset, and are the basic requirements for reliable data analysis. Maintaining these attributes is always a concern, but especially when outsourcing coding services to a third party. Our MedDRAhelp team is experienced in reviewing manufacturer submitted MedDRA coding of individual safety reports and uniquely positioned to assist your organization in achieving high coding quality.

What we offer:

At present, our QA team already reviews individual safety report coding submitted by manufacturers to the FDA. We have also provided Quality assurance support and monitoring to numerous industry clients, to ensure consistency among the customer's internal coding team or other coding entities, such as Contract Research Organizations (CROs). Our experience in utilizing proven methods, which promote accuracy, specificity, and consistency, will enable your organization and its network of CROs to overcome the steep learning curve associated with MedDRA and reap the benefits MedDRA has to offer.

Our electronic certification (eCert) solution was developed to allow automated quality assurance training and/or QA monitoring of coded data. The eCert concept is used to train coders to ensure that your coding team gains proficiency using MedDRA and achieves medical accuracy and consistency while following your organization's MedDRA coding guidelines, SOPs, and good coding principles. eCert allows QA personnel to correct codes and note the nature of any coding issues so that the coders have the benefit of the complete insight and feedback. PSI's eCert system provides an audit trail to permit a review of the protégé's progress throughout the training. PSI can offer mentors on-site or remotely, and QA the work of your coders no matter where they are located. The eCert Solution can also be used to periodically test your coding team's consistency, or to perform an independent QA of your CRO's coding results. Learn more about eCert here.

Another common approach by our clients is to send us a coded file for QA Review. We review each record and verify or modify the verbatim-LLT code assignment. If a code is changed, we provide a comment, explaining the reason for the modification. After delivering the reviewed file, we hold a telecom with the client in order to discuss the results and highlight any areas of concern.

 


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