Essential functionality delivered with each ENLIGHTEN system. |
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While each study is unique, there are a common set of imperatives that tend to vary only slightly from initiative to initiative. Therefore, MedNet provides a Core set of tools and functions in every ENLIGHTENTM eClinical Solution – vital features that are fundamental to success in every clinical study. Providing this Core enables MedNet to cost-effectively meet customer needs for easy and flexible study solutions.
ENLIGHTEN’s Core Functionality includes:
Study Management Tools
Site Documents & Site Documents Status
Allows quick and easy management of individual sites' documentation submission, monitoring of study-wide document-receipt progress, and time/date-stamped records of all site communications.
Results: Fast site start-up and reduced administrative burden.
IRB Management
Automatically notifies selected parties of upcoming IRB renewals with multiple, user-configurable, fully audit-trailed messages, and optionally suspends new patient enrollments should the renewal date pass without required documentation.
Results: Enhanced regulatory compliance and site communication.
To Do Lists
Investigators, Research Coordinators, CRAs/Monitors and more receive automatically generated To Do Lists, guiding them through required activities by providing hyperlinks to specific tasks and documents needing attention.
Results: Studies stay on schedule with enhanced protocol compliance.
Visit Planner
This clinical study management tool keeps studies on track by identifying patients due for contact within a user-defined time period, patients overdue and patients on schedule.
Results: Efficient patient scheduling, workflow planning and protocol compliance.
Patient Record Management
Provides a graphical representation of protocol-required visits and attendant study forms and activities, complete with status icons, and automatically calculates the visit window (date range) for each study interval for each patient.
Results: Efficient workflow management and increased status visibility.
Comprehensive CRF History
Delivers a time sequenced view of all patient related visits and forms, including adverse events, death/withdrawal, and other forms not related to a particular visit interval.
Results: Simplified information access and superior patient management.
Hover Help
Communicates important, configurable, context-sensitive help information by means of a pop-up dialog box that the user may retain on-screen for reference during form completion.
Results: Superior protocol compliance and increased data quality.
Conditional Branching
Simplifies and streamlines CRF data entry by actively displaying (or hiding) selected data fields based on information entered in other fields or forms.
Results: Increased site productivity and enhanced data quality.
Site Enrollment
Displays the top clinical study sites, based on enrollments and other metrics, on the study's main home page.
Results: Quick snapshot of top performers and motivated site investigators.
Data Collection Status
Provides a useful summary of study-wide patient data collection, with user-defined, color-coded highlighting of site-specific performance indicators.
Results: Quick identification of underperforming sites.
Site Dashboard
A "one-stop-shop" that allows users to manage multiple aspects of a study from a single screen, providing hyperlinked drill-down capabilities into more detailed information.
Results: Rapid access to information and increased productivity.
Training Center
Provides online training resources, including training documents and an animated streaming video walkthrough of the system with accompanying explanatory voiceover, all configured using study-specific screens, terminology and workflows.
Results: Increased user efficiency and satisfaction.
Resource Center
Facilitates the downloading and printing of PDF versions of study-specific forms and documents, such as protocols, patient information sheets, reimbursement guidelines, etc.
Results: Easy access to up-to-date materials by site, sponsor and CRO personnel.
Operations Management Tools
Create / Edit Site & Create / Edit Personnel
Allows authorized customer personnel to easily add sites and users into the system, assign them to one or more studies, and assign user privileges (roles) by study.
Results: Easy creation and maintenance of a library of investigative sites and users.
Global Messaging
This clinical study operations management tool provides timely, trackable and fully user-configurable communications to entire groups of users in one or multiple studies.
Results: Instant and auditable communication of regulatory, protocol and operational information.
Data Management Tools
eMonitoringTM
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
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.
Deviation Management
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.
Adverse Event Tracking
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.
Datasets on DemandTM
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.
Complete Audit Functions
Delivers a comprehensive package including 6 major audit tools, providing the online resources needed to track every website access and all user activities.
Results: Simplified data management and FDA/GCP compliance.
