webMethods OneData MDR for Life Sciences

webMethods OneData MDR

An Enterprise Metadata Registry Solution for the Pharmaceutical and Healthcare Industries

Clinical trial protocols are inherently different from one another, either due to the nature of the compound investigated or the therapeutic area addressed. A key business challenge is to enable each trial design to be customized to the requirements at hand, but at the same time maintain consistency of usage so as to facilitate cross-trial analysis.

Most trial-sponsoring organizations have some form of standardized data dictionary that is used to control variable and domain assignments across studies. These dictionaries typically focus strictly on usage and are treated as reusable independent variables or domains. However, there are always exceptions to the standard usage, especially if dealing with external contract research organizations (CRO).

A lack of discipline in maintaining a clean dictionary, and/or enforcing consistent usage between trials, can result in the dictionary deteriorating over time. Even variable name deviations will result in unnecessary duplicates being generated in the dictionary, reducing its utility.

Furthermore, in most cases, the evolution of standards - both internal as well as external - are not easily manageable with the standard data dictionaries used by trial-sponsoring organizations.

Other needs that are usually not satisfied with a typical setup include:

• Redundancy and duplicates over time due to the absence or poor design of a formal workflow or approval process.
• Difficulty in performing cross-trial analyses, unless the variables used in the protocol are exactly identical. Example: Arm Diastolic Blood Pressure and Diastolic Blood Pressure -- Upper Arm are the same variable. Without a proper registry, it is basically impossible to determine that programmatically.
• Challenges in maintaining the evolution of controlled vocabularies or maintenance of subsets from super-sets - this will result in the creation of redundant domain sets in the dictionary.

webMethods OneData MDR Solution Overview

webMethods OneData MDR is a central source for standard definitions, meaning, constructs and domains - all the metadata - involving all R&D phases of a pharmaceutical organization. The metadata registry allows the organization to create a platform that, on the one hand, facilitates advanced cross-trial analysis, and on the other, a flattened view to ease data collection, without compromising any aspect on either end.

The evolution of the controlled vocabulary over a period of time is handled in the registry using standard constructs. Embedded within is procedural workflow to progress standards through a formal workflow process, control versioning and retirement of standards that have been used.

Benefits of webMethods OneData MDR

• The registry enables the creation and propagation of standardized nomenclature for study design (both clinical and pre-clinical studies), irrespective of whether the terms are sourced from internal company standards or from industry standards such as CDISC SDTM.
• The registry allows for cross-trial analysis at commonality points that are variable or usage independent.
• A formal workflow can be implemented to ensure buy-in and enhance the vital communication between the various groups of people involved in a study. Ensures discipline being maintained in both definition and usage.
• Proper maintenance of controlled vocabularies as well as the evolution of controlled vocabularies over time.
• Enables variable-independent definitions of data elements. Scenarios - where the same standard element has 2 variable codes due to any reason - or the same code meaning two different elements, is easily handled in the registry.
• The registry is based on a globally accepted standard, the ISO/IEC 11179 standard used extensively by large organizations including the US National Cancer Institute (NCI).