Comprehensive solutions for exceptional data management.
MedNet provides many sophisticated tools to ensure superior data quality and control, plus streamlined and insightful data analysis. Our industry-standard Oracle relational database, combined with our exclusive database schema, support real-time, on demand reporting, providing the exact information you're looking for - from the most granular detail to the highest level strategic overview. And since the MedNet eClinical Solution is specifically designed as an Internet-based technology, there is no need to buy and install any special software. All users can access the system using any Internet connection and any operating system.
Available tools include:
Randomization Subsystem
Provides automated patient randomization using simple, 1:1, differential, multi-arm, crossover, or adaptive methodologies, and delivers detailed randomization status reports by study and by site.
| Results: | Effortless randomization assignments, straightforward monitoring and immediate unblinding for emergency assessments/treatments. |
eMonitoring™ Subsystem
Supports highly efficient identification, communication and resolution of data queries, backed by complete query dialogue trails and in-depth reporting.
| Results: | Substantial monitoring efficiencies and dramatic improvements in data quality. |
Unscheduled Events Tally
Allows instant review of unscheduled events (e.g. withdrawals, missed visits, AEs/SAEs, etc.) across the entire study, broken out by event type and study interval, with full drill-down capabilities.
| Results: | Simplified global monitoring of unexpected study events. |
Protocol Deviations
Provides complete, study wide deviation details, all in a fully sortable format with extensive hyperlinks to support more in-depth analyses.
| Results: | Early problem identification/resolution and increased protocol compliance. |
Outlier Report
Delivers a powerful, highly configurable ad hoc reporting tool that flags data values outside of normal ranges, provides drill-down links to detailed patient data, and facilitates instant communications with appropriate site personnel.
| Results: | Data trend identification (signal detection), analysis and resolution, and enhanced data quality. |
AE Report
Details all adverse events (including both site-entered and system-identified AEs) in a sortable report, populates appropriate users' To Do Lists, and triggers automatic email/fax notifications to safety/reporting groups.
| Results: | Timely AE identification and resolution, plus superior compliance. |
MedDRA Coding
Facilitates standardized MedDRA adverse event coding by the Sponsor/CRO, the site, or a combination thereof, using either full or partial MedDRA coding libraries.
| Results: | Consistent AE coding, and timely, meaningful analyses. |
Datasets on Demand™ Subsystem
Provides real-time, when-needed access to user-defined, detailed patient data in multiple downloadable formats (SAS, ASCII, XLS, etc.), metadata in Oracle or SAS/CDISC format, annotated CRFs with edit checks and validations, and comprehensive field relationship flowcharts.
| Results: | Instant retrieval of up-to-date study information, anytime, anywhere. |
VPN Access
Enables biostatisticians and data managers to directly query MedNet's Oracle Enterprise Database using their own software tools via secure access from a remote location.
| Results: | Flexible data analyses using user's preferred third-party software package. |
Detailed Field Audit
Empowers data managers with an in-depth report that details every field change made within the study web site.
| Results: | Comprehensive auditing capabilities without the need for external reporting tools. |
Form Change Log
Presents an expandable audit trail of all modifications made to each online form beyond initial data entry, detailing user, date, time, field changed, old value and new value.
| Results: | Simplified monitoring of critical forms and early identification of problematic data trends. |
Unlocked Forms Audit
Tracks all form unlocking events per 21CFR11 guidelines, and provides a fully sortable report that includes unlocking user, reason for unlocking, and more, plus convenient drill-down links into the unlocked forms.
| Results: | Regulatory compliance and easy monitoring of unlocking/modification activities. |
System User Activity Audit
Outlines high level user activity within the web site, including date, time, action, and originating IP address, in a fully filterable report.
| Results: | Easy user activity review and superior security analyses. |
IP Activity Audit
Assesses each site's log-in activity, providing a count of the log-ins from each computer (unique IP address) that accesses the web site.
| Results: | Site activity tracking and proactive security auditing. |
Website Activity Audit
Delivers a high level analysis of overall site log-ins, regardless of the originating computers' IP addresses.
| Results: | Quick identification of relatively inactive sites and proactive site interventions. |
