MedDRA Services

The MSSO provides coding services to clients who need experienced MedDRA coding personnel. The MSSO's MedDRA coding service includes coding by an experienced MedDRA coder and quality review by an MSSO physician. The MSSO works with you to meet your schedule constraints and provides the finished data in the format you specify.

To find out more about MedDRA coding services, contact the MSSO.

Organizations with data coded in legacy terminologies (COSTART ©, WHO-ART ©, ICD-9 ©, etc.) may face some challenges when converting these data to MedDRA.

There is an efficient, cost-effective way to meet these challenges. The MedDRA MSSO offers services to facilitate and accelerate the conversion of data coded in an older terminology to MedDRA.

The MSSO team, with its unmatched combination of technical expertise and MedDRA knowledge, has worked closely with all sectors of the biopharmaceutical, biotechnology, and medical informatics industries. Team members are fully skilled in MedDRA training, implementation, and legacy data conversion.

Typical Services in Legacy Conversion

• Analysis and design of an information technology system solution for database conversion
• Correct mapping of legacy data to MedDRA, with MedDRA recoding as required
• Creation of legacy data conversion coding conventions
• Design and execution of statistical programs for appropriate data display
• Creation of reports and tables for comparison with legacy information
• Medical analysis of converted data

To find out more about MedDRA legacy database conversion services, contact the MSSO.

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.