TrialKit Features
Data Management (13)
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Cloud Security - Electronic Data Capture (EDC)
Hosts the EDC system in the cloud and provides data security
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Role-Based User Permissions - Electronic Data Capture (EDC)
Sets up and determines designated permission levels for users
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Query Management - Electronic Data Capture (EDC)
Auto-generates or simplifies the manual addition of queries that require action in order to lock data
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Data Export - Electronic Data Capture (EDC)
Eases the export of clinical data for tracking and reporting purposes
Data Import/Export
Import and export data to and from software applications
Workflow Management
Create, design and manage workflows for repetitive tasks
Compliance Management
Track and manage adherence to policies for any service, product, process, or supplier
Clinical Study Management
Tools to manage single or multiple clinical studies within a centralized platform
Document Management
Store, manage, and track all electronic documents in a centralized location
Audit Management
Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws
Forms Management
Store, manage and track all forms in a centralized location
Data Storage Management
Manage and store data in a database
Access Controls/Permissions
Define levels of authorization for access to specific files or systems
Clinical Study Support (8)
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eCRFs - Electronic Data Capture (EDC)
Facilitates the creation and storage of electronic case report forms and templates
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Audit Trail - Electronic Data Capture (EDC)
Tracks history of and any changes made to eCRFs or captured data
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Data Capture - Electronic Data Capture (EDC)
Provides 1 or more methods to electronically collect clinical trial data
Randomization - Electronic Data Capture (EDC)
Manages patient enrollment and study randomization
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Compliance - Electronic Data Capture (EDC)
Ensures compliance with regulatory requirements like 21 CFR Part 11
Real-Time Data
Receive data and information in real time
Remote Data Capture
Capture data electronically
Distributed Capture
Uses decentralized resources such as network scanners, multi-function devices (MFD), and desktop scanners to collect data and documents
Operational Data (15)
Site Management
Provides oversight on site-specific details, participation status, enrollment planning, and site communications.
Participant Management
Coordinates, tracks, monitors, and manages participants enrolled in upcoming or ongoing clinical trials.
Data Centralization
Consolidates and centralizes study-relevant data and information.
Contact Management
Gathers and collects contact information for trial participants.
Real-Time Data
Receive data and information in real time
Inventory Management
Track and manage inventory levels to maintain proper supply
Audit Management
Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws
Calendar Management
Track and manage schedules and meetings via an integrated calendar
Financial Management
Plan, manage, and track the financial activities of an individual or organization
Document Management
Store, manage, and track all electronic documents in a centralized location
User Management
Manage user accounts, profiles, roles, permissions, and other details across applications, devices or networks
Clinical Study Management
Tools to manage single or multiple clinical studies within a centralized platform
Workflow Management
Create, design and manage workflows for repetitive tasks
Compliance Management
Track and manage adherence to policies for any service, product, process, or supplier
Forms Management
Store, manage and track all forms in a centralized location
Operational Performance (5)
Project Management
Coordinates, tracks, monitors, and manages upcoming or ongoing clinical trials.
Documentation
Records and administers study- and site-specific documents, forms, and activities.
Reporting
Enables continuous and up-to-date reporting during studies.
Milestones Management
Allows customization of study's key dates; tracks deadlines and milestones; issues progress reports.
Ad hoc Reporting
Generate one-off reports that meet information requirements
Regulatory Compliance (4)
Dashboards and Reporting
Offers customizable dashboards and analytics to track completeness, compliance, quality, and timeliness of the study.
TMF Reference Models
Offers a pre-built DIA TMF reference model hierarchy, and allows for configurable reference models to meet the specific needs of organizations and sponsors.
Inspection Readiness
Supports inspections and regulatory audits by maintaining inventory and document reports, and having pre-built compliance with all relevant regulatory guidelines.
Role Permissions
Designates customizable user roles and limit access to certain functions in the eTMF.
Content Management (7)
Bulk Upload and Indexing
Allows users to upload multiple documents at once and provides dynamic indexing options.
Document Tracking
Manages the status of all trial documentation at all stages and flags missing documentation.
Version Controlling
Tracks each version of a document and shows changes from each version or reupload.
Search Engine
Allows documents and metadata to be easily searched within the system.
File Planning and Milestones
Establishes study level, country level, and site level milestones and what amount of mandatory and optional documents need to be collected throughout the study lifecycle.
Real-Time Authoring and Collaboration
Allows external or remote contributors to upload documents and work collaboratively in a controlled method.
Content Workflows
Configures review, e-signature, and approval workflows for all documentation.
Additional Functionality (71)
API
Application programming interface that allows for integration with other systems/databases
Scheduling
Plan availability and assign specific time slots for tasks and resources
Randomization
Randomize the displayed order of questions and answer options
Digital Signature
Electronic signing method that validates the authenticity and integrity of a digital document
Role-Based Permissions
Set & manage permission levels based on user roles and restrict access to only authorized individuals
Customizable Reports
Alter the layout and content of reports
Data Verification
Process of checking different types of data for accuracy to avoid errors or inconsistencies
EMR/EHR
Create and securely store digital patient records
Document Imaging
Convert paper files into digital images
AI Copilot
A virtual assistant that uses AI to pursue goals and complete tasks on behalf of users
HIPAA Compliant
Compliant with HIPAA, which sets standards for sensitive patient data protection
Data Visualization
Graphical representation of data
Data Capture and Transfer
Import, collect, and capture data from multiple sources
Enrollments/Onboarding
Manage the enrollment and onboarding of all new members and accepted applications
Reporting & Statistics
Collection, analysis, and representation of numerical data and generation of reports to understand various patterns
Patient Monitoring
Observing and tracking a patient's health status, condition, and wellbeing
Access Controls/Permissions
Define levels of authorization for access to specific files or systems
Patient Recruiting
Helps clinical trials/labs get patients for participation.
Alerts/Notifications
Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges
Activity Dashboard
Dashboard to view the status of ongoing processes, identify current incidents and track past activities
Third-Party Integrations
Set up connections to third-party platforms to improve business processes
Monitoring
Observe and track the demand, usage, progress or quality of a system, product, or user
CRF Tracking
Collect and track all case report forms (CRFs) within a centralized repository
21 CFR Part 11 Compliance
Shows that electronic documents are authentic and linked to specific records
Double Data Entry
Data entry quality control method that involves recording the same data twice to maintain integrity
Activity Tracking
Track and document all activities across devices, networks, and other systems
Progress Tracking
Reporting on how each user, task or process has advanced since its initiation
Reminders
Timed notification for any upcoming task, deadline, appointment, or activity
Data Synchronization
Synchronizing data between two or more devices/systems and automatically updating changes to maintain consistency
Data Import/Export
Import and export data to and from software applications
Document Storage
Store and organize documents in a centralized system
Generative AI
Use AI to generate content in the form of text, images, videos, etc.
Trial Design
Allows clinics and academic institutions to create trials and studies from scratch.
Customizable Forms
Customize contracts and forms to collect specific information
Drag & Drop
Assemble applications and processes by dragging over and arranging pre-built components
Audit Trail
A record of all activities within the system, including user access, changes made, etc.
Real-Time Monitoring
Active monitoring of systems, applications, or networks
Electronic Data Capture
Import, collect, and capture data from multiple sources
Secure Data Storage
Securely stores data to prevent data loss or breaches
Alerts/Notifications
Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges
Web Forms
Web form that allows users to enter data that is sent and processed for different reasons
Approval Process Control
Manage the process of evaluating documents or requests submitted for approval
Configurable Workflow
Configure existing workflows to meet your organization's needs
Real-Time Reporting
Active reporting of data and metrics
Electronic Signature
Digitally sign online documents
Mobile Access
Access software remotely via mobile devices
Third-Party Integrations
Set up connections to third-party platforms to improve business processes
Drag & Drop
Assemble applications and processes by dragging over and arranging pre-built components
Offline Access
Ability of websites, web applications, or mobile applications to function without an active internet connection
Customizable Branding
Add customized logos and colors to align with company branding
Generative AI
Use AI to generate content in the form of text, images, videos, etc.
Document Imaging
Convert paper files into digital images
Customizable Fields
Customize data fields to support various needs and use cases
AI Copilot
A virtual assistant that uses AI to pursue goals and complete tasks on behalf of users
Customizable Forms
Customize contracts and forms to collect specific information
Document Storage
Store and organize documents in a centralized system
Data Capture and Transfer
Import, collect, and capture data from multiple sources
Data Visualization
Graphical representation of data
Data Synchronization
Synchronizing data between two or more devices/systems and automatically updating changes to maintain consistency
Data Verification
Process of checking different types of data for accuracy to avoid errors or inconsistencies
HIPAA Compliant
Compliant with HIPAA, which sets standards for sensitive patient data protection
Customizable Reports
Alter the layout and content of reports
Audit Trail
A record of all activities within the system, including user access, changes made, etc.
Reporting/Analytics
View and track pertinent metrics to find patterns and gain insights from data
Customizable Templates
Pre-designed layouts that can be customized to match preferences and requirements
Document Classification
Assign categories, labels, tags, or attributes to documents for organization, search and storage
Data Extraction
Automatically retrieve and pull information from documents, websites, images, data sets, and other sources
API
Application programming interface that allows for integration with other systems/databases
Digital Signature
Electronic signing method that validates the authenticity and integrity of a digital document
Activity Dashboard
Dashboard to view the status of ongoing processes, identify current incidents and track past activities
Multi-Language
Manage and support multiple languages


