Developing a Tailored MedDRA Strategy for Your Enterprise

Implementing the MedDRA terminology requires a detailed, targeted plan that is specific to each organization. A needs assessment by the MedDRA MSSO will pinpoint the specific areas you should address and explain how best to address them to ensure smooth implementation of MedDRA.

The MSSO will perform an enterprise-wide assessment to identify the impacts of MedDRA, develop initial steps to be taken, recommend required training, identify resource impacts, and provide an initial schedule of implementation.

MedDRA experts will make site visits to conduct detailed interviews with the various components of the organization involved in or affected by MedDRA implementation. The MSSO team will also code sample organizational datasets to demonstrate familiar terms as coded in MedDRA. The team will provide a draft report and briefing of findings, after which it will finalize the report incorporating comments from the organization.

Key Elements of MedDRA Needs Assessment

• Initial plan of action
• Insight into the timing and implementation of MedDRA for clinical trials and data conversion
• Identification of impacted areas (e.g., clinical, drug safety, data management, labeling, information systems, dictionary management)
• Sample coded datasets mapping the organization's terms to MedDRA
• Identification and discussion of impacts of interfaces outside the organization (e.g., CROs, co-marketers/co-developers)
• Briefing of findings and recommendations
• Written assessment documents (draft and final)