An Intelligent eProtocol Design System

Medidata Designer^®, with the Designer Gateway, is a unique eProtocol design solution that can transform sponsors’ existing protocol authoring methods into a truly strategic practice that benefits the entire clinical study process. Sponsors can gain significant benefits in quality, efficiency and speed to market by enhancing authoring SOP compliance, reducing EDC set up time and eliminating unnecessary data collection efforts.

Improve Protocol Quality and Reduce Trial Costs

Built-in, real-time authoring advisories ensure explicit linkages across objectives, endpoints and procedures and detect any inconsistencies. Focusing on the most important study objectives and eliminating unnecessary data collection in the design phase lead to substantial cost savings in downstream operations such as the number and complexity of clinical procedures and data management processes—up to 20% in some cases.

Enhance & Measure SOP and Standards Compliance

Sponsors’ ability to measure and enforce governance of protocol authoring SOPs and standards is greatly enhanced with Designer:

• Reusability: Prototypical designs are captured as templates with built-in, reusable SOPs that can be enforced across the organization
• Visibility: Cross team review capabilities and collaboration tools enhance the authoring process and reduce unnecessary rework
• Maintainability: Centrally administered standard content enhances sponsors' control and reduces regulatory risks

Streamline Clinical Execution

Structured authoring with XML backbone enables eProtocol metadata to be shared with downstream systems such as EDC/CDM and statistical analysis systems. Integration at the data and process level allows work from protocol development phase to be reused throughout clinical processes, significantly reducing the time, costs and risks associated with reentry and interpretation of paper protocol documents.

Apply Closed Loop Metrics and Business Intelligence

Medidata Designer’s robust data model enriches the protocol metadata with an end-to-end clinical context that reveals critical insights into key operational metrics, which were once difficult or impossible to obtain during protocol development or execution. The impact of design decisions can now be dynamically anticipated by querying data sources such as the Medidata PICAS^® database for study costs, industry benchmarks, historical references and other performance metrics. Effective protocol design can pave the way for more efficient study execution and continuous process improvement in a true closed loop trial environment.