User:Shawndouglas/sandbox/sublevel4

Medical research laboratories (e.g., central and contract labs) form the backbone of today's effective medical treatments, through the pathway of clinical trials. These clinical trials involve analytical testing and other activities across many domains, including pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management. These activities require extra features beyond those found in a basic clinical diagnostics LIMS in order to effectively collect and use the clinical trial data in a secure and meaningful way.

In addition to the essential features of a standard LIMS, the central and contract research lab conducting clinical trials will also be looking for a system that can (or allows users to):

• Manage and track clinical trial kits.
• Manage multi-site logistics of specimens.
• Provide a reservation function for specimens.
• Manage clinical trials and their various functions, including recruitment, study protocols, treatment groups, metadata, multi-site master scheduling, consent checks and other required reporting.
• Provide special access privileges to sponsors, monitors and investigators.
• Support a wide variety of data transfer formats, including CDISC, ASCII, SAS and XML.
• Provide patient management, including demographics, consent forms, clinical notation and test results.
• Provide highly configurable "blinding" features for reports and the user interface.
• Track contracts, budgets and other financials.
• Develop exclusion rules and monitor exclusions.
• Support testing for a wide variety of disciplines.
• Provide study-specific monitoring and alerts.
• Provide granular cumulative reporting.
• Provide study-specific project portals that allow review of documents, data visualizations, training material and other study information.