Features

The data collection-centric approach of electronic data capture (EDC) systems has led to three main industry-wide limitations:

Limited User Scope
- Features benefit only data entry staff and coordinators.

Disengaged Participants
- Subjects only experience the burden of data entry

Complex Analysis
- Data analysis is a complicated, protracted and disconnected process

Clear Vision

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:

Data Entry
- Incorporate interactive, multi-media web-based materials such as audio, video, pictures, links, etc.
- Pause any time, and automatically restart where left off
- Numerous control options including sliders and directly clicking on an image
- Use phone, tablet or PC
Multi-Study Access
- Navigate between multiple studies using a single account.

Reward Points
- Earn points for completing forms / events
- Redeem points anytime for gift / debit cards.
- Auto-log redemption instructions
Secure Messaging
- Send text, files, or camera pictures
- Manage multiple conversations
Smart-Content
- 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')

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:

Central Calendar
- Coordinate and schedule events across one or more studies using a single, integrated calendar
- Select form numerous calendar view options (e.g., list, calendar; date range; study filter, etc.)
Coordinate Data Oversight
- Create 'To-Do' lists using configurable criteria (e.g., last week's incomplete events, open AEs involving headache)
  - Add a custom label to each list, assign to specific user or to user group
- Manage open queries and related communication within and across sites
- Create reports on enrollment, data quality, etc. across multiple studies, generate with single click
Event Notifications
- Configure automated event notifications using a variety of different trigger types (e.g., adverse event entered, participant reported high anxiety)

Automated Documentation
- 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)
- 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.
Study Management
- Visualize progress
  - View study events on a zoomable, visual timeline
  - Custom color code events and associated characteristics to easily identify issues
- Standardize and monitor e-Consent, screening and enrollment methods.
- Assign user roles and access (e.g., user able to randomize at Site X)
- Provide secure user access to study related training materials, SOPs, enrollment summaries, etc.
- Ensure accurate execution across various designs (e.g., clinical trials, patient registries, surveys) and data collection events (e.g., diaries, adverse events)

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:

Publish Faster
- Streamline academic output (manuscripts, abstracts, presentations) and materials (images, datasets, analysis files) in a centralized "Workbench"
- Efficient Workflow: Store and instantly locate files and datasets to address reviewer comments
- One-Click Duplication: Copy all publication-related work (e.g., variable coding, analyses, datasets) with a single click
  - Example: Use Year 1 longitudinal data analysis setup as a template for Year 2 follow-up publication
- Table Design: Directly connect study data to publication ready tables, update numbers on demand
  - Point-and-Click: Build tables by adding variable rows/columns (e.g., sex, race by study site)
  - Flexible Display: Choose summary options [e.g., n, n (%), mean, mean (SD)]
  - On-the-Fly Edits: Relabel variables instantly (e.g., "Post-surgical bleeding level" to "Bleed Level")
  - 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)
- Integrated Output: Combine tables, text, and images in a user-friendly word processor interface.

Facilitate Clinical Practice (i.e., registries)
- Create dynamic, programmable reports tailored to diverse needs (see here), featuring:
  - Configurable Text: Combine boilerplate text with data-driven values, logic-based text, calculations, and decision analysis
  - Visualizations: Include charts, graphs, color-coded data, dynamic images (e.g., tumor location-based), disease/treatment timelines, and decision-making algorithms
  - AI Integration: Auto-generate prompts with data for AI tools (e.g., Vertex AI)
  - Patient Engagement: Deliver personalized, relevant disease information to patients
Flexible Design & Methods
- Study Types: Clinical trials, patient registries, surveys
- Methods
  - Participant Only
    - Participant-Only: Fully automated online studies with planned engagement, no staff interaction required
  - Participant + Staff Combination
    - Collaborative progression and data collection involving both participants and staff
  - Staff Only
    - Staff-driven recruitment and data collection (e.g., clinic-based), with participants only providing eConsent
- Versatile Data Acquisition
  - Manage complex longitudinal collection schedules (e.g., adverse events, diaries, multiple study arms) with programmable start / continue / end

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:

Centralize Analysis Hub
- Coordinate data analysis across multiple studies in an integrated "Workbench" directly linked to study data
- 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:
  - Grant access to authorized users
  - Build and organize tailored data sets
  - Store related files (e.g., images, statistical output files, etc.)
  - Create publication-ready tables
  - Generate reports via a word-processor interface, blending text and tables with on-demand analysis updates
- Produce across-study reports, instantly refreshable (e.g., enrollment summaries for all active department studies)
Off-Load Work
- Enable non-technical, non-statistical staff to handle common time consuming, repetitive tasks (e.g., enrollment / progress / IRB reports)
- Export data anytime in multiple formats (e.g., SAS, Excel, CSV)

Streamlined Data Set Creation
- Build data sets without understanding the underlying data model, using a user-friendly point-and-click interface to add variables and study events.
- Create data sets that facilitate the analytical plan with sophisticated, integrated tools:
  - Raw: Select entire forms or individual variables for inclusion
  - On-the-Fly Variable Creation
    - Recoded Variables:
      - Nominal / Ordinal
        
        Dynamically combine groups (e.g., dummy coding)
      - Interval / Ratio
        
        Create categories based on value range (e.g., 0 - 100) and custom labels
    - Calculated Variables:
      - Perform any calculation using advanced programming (e.g., JavaScript)
      - Generate continuous (e.g., pulse pressure) or categorical values with labels
- Dynamic Extraction
  - Automate data extraction routines (e.g., baseline and latest follow-up heart rate) for efficient analysis

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:

Minimize Effort
- Share data across projects (e.g., birthdate)
- Import data from other systems / devices
- Incentivize participant data entry
- Pre-populate longitudinal forms, update only if change (e.g., seizure frequency across clinic visits)
- Create profiles to automatically assign variable values (e.g., negative medical history)
- Immediate validation feedback
- Ability to assign time range to data values, automatically associated with visits within range (e.g., medication use)
- Automated data completion dashboard, visual timeline, and data validation reports
Model Existing Workflows
- Configure data capture steps to match staff / participant touch-points (e.g., nurse --> physical therapist --> physician)

Form Design
- Flexible layout (e.g., grid) and variable controls (e.g., slider)
- Incorporate multi-media (e.g., video, images, audio), including image overlays for visually guided data entry
- In-line access to data definition and audit trail details, queries and related communication exchange, variable help / instructions
- Comprehensive validation, instant feedback
- Dynamic prompts (e.g., insert specific names on a family medical history form)
- Automated data completion status
Data Capture Methods
- Flexible data capture scheduling, including logic driven start / stop (e.g., adverse events, study arms, participant diaries, etc.)
- Guided sequencing and tracking of screening, eConsent, enrollment and follow-up data collection

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:

Streamlined Participant Payments
- Drastically cut labor costs through automated participant payment system (see here)
  - Seamless Integration: Directly tie study event completion to reward points
    - 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)
  - Automated Tracking: Monitor participant reward point totals in real time
  - Self-Service Payments: Allow participants to redeem points for gift/debit cards anytime, without assistance
  - Transparent Auditing: Maintain a complete audit trail of all disbursements
  - Comprehensive Reporting: Generate annual per-participant payment summaries for 1099 reporting

Optimize Reporting
- Enable non-technical and non-statistical staff to fulfill organizational reporting requirements (e.g., IRB / progress / enrollment / adverse event reports)
- Ensure on-time report submission
  - Reports are directly linked to study data, automatically update numbers on demand
Unified Data Standards
- Create universal forms and data definitions (e.g., Demographics, Contact Information) for consistent reporting across organization
  - Enter data once (e.g., birth date) for seamless access across all projects
Manage Access
- Wrap research activities within a 21-CFR-pt.11 compliant system
- Implement role-based access at the project level
- Configure organization-wide security rules (e.g., password policies, dual authentication)

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:

Configurable Setup
- Direct access to HTML, integrated and custom CSS, and javascript to assist with:
  - Form Design
    - Layout and design
    - Data entry validation
    - Variable options (e.g., control type, image-based data entry)
  - Screening / Enrollment Management
    - Programmatically manage even the most complicated screening 'run-in' periods and enrollment criteria
  - Advanced Reporting
    - Extensive reporting options to facilitate the immediate use of data
    - Incorporate nearly anything that can be done on the web (e.g., see here)
    - Individual participant, entire study, and multi-study reporting, updatable on demand

Advanced API
- Extensive access to application functionality through an API to allow for flexible data exchange and automation
- RESTful Web Services
Data Set Design
- Help enable statisticians and principal investigators to create robust data sets by leveraging JavaScript to dynamically generate on-the-fly variables
  - Design continuous or categorical variables
  - Write functions using Javascript to generate variable values
Workflow Lists
- 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)
  - Generate within or across projects
  - Assign to specific user or group

participants

studycoordinator

Invesigators

Statisticians

Dataentry

Administrators

Technical