
Features
The data collection-centric approach of electronic data capture (EDC) systems has led to three main industry-wide limitations:
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Limited User Scope
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Features benefit only data entry staff and coordinators.
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Disengaged Participants
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Subjects only experience the burden of data entry​
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Complex Analysis
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Data analysis is a complicated, protracted and disconnected process
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Studytrax eliminates this blind spot with features that target the needs of all user groups, creates a personalized, interactive experience for participants, and integrates the analytical and publication process.
Users:
For Participants...
Provide an interactive, personalized experience through a portal that delivers dynamic information exchange, reward point incentives, close communication and a consistent experience across studies.
Examples:
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Data Entry
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Incorporate interactive, multi-media web-based materials such as audio, video, pictures, links, etc.​
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Pause any time, and automatically restart where left off​
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Numerous control options including sliders and directly clicking on an image
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Use phone, tablet or PC
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Multi-Study Access
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Navigate between multiple studies using a single account.
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Reward Points
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Earn points for completing forms / events
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Redeem points anytime for gift / debit cards.​
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Auto-log redemption instructions
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Secure Messaging
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Send text, files, or camera pictures
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Manage multiple conversations
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Smart-Content
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Automatically generate personalized disease information and/or educational materials based on participant's own data (e.g., show wheelchair transfer training video if 'Transfer Difficulties?' marked as 'Yes')
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For Study Coordinators...
Provide a smart, integrated platform that streamlines research operations, ensures quality data, fits existing workflows, enables secure communication, and optimizes oversight.
Examples:
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Central Calendar
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Coordinate and schedule events across one or more studies using a single, integrated calendar
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Select form numerous calendar view options (e.g., list, calendar; date range; study filter, etc.)
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Coordinate Data Oversight
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Create 'To-Do' lists using configurable criteria (e.g., last week's incomplete events, open AEs involving headache)
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Add a custom label to each list, assign to specific user or to user group
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Manage open queries and related communication​ within and across sites
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Create reports on enrollment, data quality, etc. across multiple studies, generate with single click
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Event Notifications​
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Configure automated event notifications using a variety of different trigger types (e.g., adverse event entered, participant reported high anxiety)​
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Automated Documentation
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Instantly generate required documentation (e.g., protocol violation, AE report, medication change summary), flexible word-processor-based setup of formatting and display options, drag-and-drop controls (e.g., charts, tables)
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Generated documentation can range from simple boilerplate text auto-filled with participant data to sophisticated text generation logic, decision analysis, and/or summary of information from one or a combination of events. ​
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Study Management
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Visualize progress
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View study events on a zoomable, visual timeline
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Custom color code events and associated characteristics to easily identify issues
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Standardize and monitor e-Consent, screening and enrollment methods.​
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Assign user roles and access (e.g., user able to randomize at Site X)
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Provide secure user access to study related training materials, SOPs, enrollment summaries, etc.
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Ensure accurate execution across various designs (e.g., clinical trials, patient registries, surveys) and data collection events (e.g., diaries, adverse events)
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For Investigators...
Provide tools that accelerate research, streamline analysis and reporting, and leverages data real-time for better clinical decisions, treatments, and patient education.
Examples:
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Publish Faster
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Streamline academic output (manuscripts, abstracts, presentations) and materials (images, datasets, analysis files) in a centralized "Workbench"
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Efficient Workflow: Store and instantly locate files and datasets to address reviewer comments
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One-Click Duplication: Copy all publication-related work (e.g., variable coding, analyses, datasets) with a single click
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Example: Use Year 1 longitudinal data analysis setup as a template for Year 2 follow-up publication
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Table Design: Directly connect study data to publication ready tables, update numbers on demand​​​​
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Point-and-Click: Build tables by adding variable rows/columns (e.g., sex, race by study site)​
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Flexible Display: Choose summary options [e.g., n, n (%), mean, mean (SD)]
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On-the-Fly Edits: Relabel variables instantly (e.g., "Post-surgical bleeding level" to "Bleed Level")
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Dynamic Recoding: Simplify variables (e.g., 8 racial categories to 2) or create new variables (e.g., normal vs. hypertension split on 130 systolic blood pressure)
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Integrated Output: Combine tables, text, and images in a user-friendly word processor interface. ​​​
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Facilitate Clinical Practice (i.e., registries)
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Create dynamic, programmable reports tailored to diverse needs (see here), featuring:
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Configurable Text: Combine boilerplate text with data-driven values, logic-based text, calculations, and decision analysis
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Visualizations: Include charts, graphs, color-coded data, dynamic images (e.g., tumor location-based), disease/treatment timelines, and decision-making algorithms
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AI Integration: Auto-generate prompts with data for AI tools (e.g., Vertex AI)​
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Patient Engagement: Deliver personalized, relevant disease information to patients
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Flexible Design & Methods
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Study Types: Clinical trials, patient registries, surveys​
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Methods​​
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Participant Only
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Participant-Only: Fully automated online studies with planned engagement, no staff interaction required
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Participant + Staff Combination
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Collaborative progression and data collection involving both participants and staff
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Staff Only
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Staff-driven recruitment and data collection (e.g., clinic-based), with participants only providing eConsent
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Versatile Data Acquisition​​
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Manage complex longitudinal collection schedules (e.g., adverse events, diaries, multiple study arms) with programmable start / continue / end
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For Statisticians...
Provide tools to create and manage complex datasets, streamline data cleaning and review, off-load compliance and progress reporting, and eliminate redundant work.
Examples:
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Centralize Analysis Hub
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Coordinate data analysis across multiple studies in an integrated "Workbench" directly linked to study data
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Create a dedicated 'Workspace' for each planned academic (e.g., manuscript, poster) or reporting initiative (e.g., QA reports) to coordinate all related activities and content:
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Grant access to authorized users
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Build and organize tailored data sets
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Store related files (e.g., images, statistical output files, etc.)
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Create publication-ready tables
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Generate reports via a word-processor interface, blending text and tables with on-demand analysis updates
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Produce across-study reports, instantly refreshable (e.g., enrollment summaries for all active department studies)
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Off-Load Work
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Enable non-technical, non-statistical staff to handle common time consuming, repetitive tasks (e.g., enrollment / progress / IRB reports)
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Export data anytime in multiple formats (e.g., SAS, Excel, CSV)
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Streamlined Data Set Creation
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Build data sets without understanding the underlying data model, using a user-friendly point-and-click interface to add variables and study events.
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Create data sets that facilitate the analytical plan with sophisticated, integrated tools:
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Raw: Select entire forms or individual variables for inclusion
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On-the-Fly Variable Creation
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Recoded Variables:
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Nominal / Ordinal​
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Dynamically combine groups (e.g., dummy coding)​
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Interval / Ratio​
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Create categories based on value range (e.g., 0 - 100) and custom labels​
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Calculated Variables:
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Perform any calculation using advanced programming (e.g., JavaScript)
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Generate continuous (e.g., pulse pressure) or categorical values with labels
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Dynamic Extraction ​​
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Automate data extraction routines (e.g., baseline and latest follow-up heart rate) for efficient analysis ​
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For Data Entry Staff...
Deliver powerful tools for fast, accurate data input—featuring intuitive forms, multimedia support, image overlays, built-in validation, real-time dashboards, and streamlined communication and tracking workflows.
Examples:
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Minimize Effort
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​Share data across projects (e.g., birthdate)
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Import data from other systems / devices
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Incentivize participant data entry
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Pre-populate longitudinal forms, update only if change (e.g., seizure frequency across clinic visits)
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Create profiles to automatically assign variable values (e.g., negative medical history)
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Immediate validation feedback
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Ability to assign time range to data values, automatically associated with visits within range (e.g., medication use)
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Automated data completion dashboard, visual timeline, and data validation reports
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Model Existing Workflows
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Configure data capture steps to match staff / participant touch-points (e.g., nurse --> physical therapist --> physician)
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Form Design
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​Flexible layout (e.g., grid) and variable controls (e.g., slider)
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Incorporate multi-media (e.g., video, images, audio), including image overlays for visually guided data entry
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In-line access to data definition and audit trail details, queries and related communication exchange, variable help / instructions
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Comprehensive validation, instant feedback
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Dynamic prompts (e.g., insert specific names on a family medical history form)
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Automated data completion status
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Data Capture Methods
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​Flexible data capture scheduling, including logic driven start / stop (e.g., adverse events, study arms, participant diaries, etc.)
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Guided sequencing and tracking of screening, eConsent, enrollment and follow-up data collection
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For Administrators...
Enable data collection standards and access controls, ensure accurate participant screening and enrollment, automate required reporting, and streamline the participant payment process
Examples:
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Streamlined Participant Payments
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Drastically cut labor costs through automated participant payment system​ (see here)
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Seamless Integration: Directly tie study event completion to reward points
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Flexible Triggers: Award points based on participant actions (e.g., form completion), staff actions (e.g., procedure data collection), or system-driven events (e.g., data imports) ​
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Automated Tracking: Monitor participant reward point totals in real time
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Self-Service Payments: Allow participants to redeem points for gift/debit cards anytime, without assistance
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Transparent Auditing: Maintain a complete audit trail of all disbursements
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Comprehensive Reporting: Generate annual per-participant payment summaries for 1099 reporting
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Optimize Reporting
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Enable non-technical and non-statistical staff to fulfill organizational reporting requirements (e.g., IRB / progress / enrollment / adverse event reports)
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Ensure on-time report submission ​
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Reports are directly linked to study data, automatically update numbers on demand ​
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Unified Data Standards
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Create universal forms and data definitions (e.g., Demographics, Contact Information) for consistent reporting across organization
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Enter data once (e.g., birth date) for seamless access across all projects
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Manage Access
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Wrap research activities within a 21-CFR-pt.11 compliant system
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Implement role-based access at the project level
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Configure organization-wide security rules (e.g., password policies, dual authentication)​
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For Technical Staff...
Studytrax delivers intuitive functionality requiring no technical expertise. For advanced needs, it provides full customization via HTML, CSS, and JavaScript for tailored forms, validation, and reporting and a robust API for seamless integration and task automation.
Examples:
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Configurable Setup
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Direct access to HTML, integrated and custom CSS, and javascript to assist with:
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Form Design​
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Layout and design​
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Data entry validation
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Variable options (e.g., control type, image-based data entry)
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Screening / Enrollment Management
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​​​​Programmatically manage even the most complicated screening 'run-in' periods and enrollment criteria
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Advanced Reporting
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Extensive reporting options to facilitate the immediate use of data
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Incorporate nearly anything that can be done on the web (e.g., see here)​​
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​Individual participant, entire study, and multi-study reporting, updatable on demand​​
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Advanced API
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Extensive access to application functionality through an API to allow for flexible data exchange and automation​
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RESTful Web Services
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Data Set Design
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Help enable statisticians and principal investigators to create robust data sets by leveraging JavaScript to dynamically generate on-the-fly variables​
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Design continuous or categorical variables​
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Write functions using Javascript to generate variable values
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Workflow Lists​
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Assist with study execution and workflow via creation of filters that can be named and run to generate custom participant lists (e.g., due in next two weeks)​
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Generate within or across projects​
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Assign to specific user or group
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