MedDRA Services

The MSSO offers comprehensive services to assist the user community in implementing MedDRA. In addition to training, the MSSO can provide services such as assessment of MedDRA's impacts on your organization, help with a single MedDRA implementation task, or full MedDRA implementation services.

Needs Assessment

Developing a Tailored MedDRA Strategy for Your Enterprise

Implementing MedDRA requires a detailed, targeted plan that is specific to each organization. A Needs Assessment by the MedDRA MSSO pinpoints the specific areas you should address and explains how best to address them to ensure smooth implementation of MedDRA.

The MSSO performs 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 make site visits to conduct detailed interviews with the various components of the organization involved in or affected by MedDRA implementation. If requested, the MSSO team also codes sample organizational datasets to demonstrate the impact of a conversion to MedDRA. The team provides a draft report and briefing of findings, after which it finalizes the report incorporating comments from the organization.

Key Elements of a 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
• How MedDRA may impact the organization's contractors (e.g., CROs) and partners
• Briefing of findings and recommendations
• Written assessment documents (draft and final).

To find out more about MedDRA needs assessment services, contact the MSSO Help Desk.