Clinical Excellence (Cx)

Clinical Excellence (Cx) by MasterControl is a clinical manufacturing management solution designed for life science companies that need to connect, manage, track, organize, and store documents, images, and other essential digital content as part of their electronic trial master file (eTMF) throughout the clinical trial lifecycle. The platform is purpose-built to unite clinical operations and clinical quality teams on a single, centralized system, eliminating the inefficiencies that arise from using disparate tools.

Clinical trials generate an ever-growing collection of data, activities, and relationships that can shift dramatically from day to day. MasterControl Clinical Excellence addresses this complexity by replacing manual, paper-based processes with streamlined digital workflows, giving organizations real-time visibility into critical clinical processes across all operational teams.

Core Capabilities

• Centralized eTMF management that digitizes, automates, and connects all documents and artifacts required throughout the clinical trial lifecycle
• Orchestration of site protocols, standard operating procedures (SOPs), and reporting across multiple sites
• Real-time visibility into critical clinical processes across operational teams on one unified platform
• Seamless integration of clinical quality processes directly into clinical trial operations
• Risk management tools embedded within clinical workflows to support proper oversight
• GCP compliance enablement through operationalized quality processes

Key Benefits

• Eliminates costly, time-consuming bottlenecks caused by manual and paper-based documentation processes
• Accelerates clinical trials by improving alignment between clinical operations and quality teams
• Maintains indivisible connections between clinical operations and clinical quality on a single platform
• Supports efficient, consistent, and well-managed clinical processes that contribute to successful trial outcomes
• Enables faster and smarter clinical quality manufacturing through modernized operations

Who It Is For

• Life science companies managing complex clinical trials requiring robust eTMF solutions
• Clinical operations teams seeking to reduce reliance on disparate systems
• Clinical quality teams that need to embed quality management directly into trial workflows
• Organizations preparing for FDA inspections of clinical investigators and requiring strong GCP compliance documentation

MasterControl Clinical Excellence is part of the broader MasterControl platform, which also includes Manufacturing Excellence and a Quality Management System (QMS). MasterControl tailors pricing plans to fit individual business needs, making the solution accessible to organizations at various stages of their clinical development lifecycle.