TrialKit Features

Data Management (4)

Cloud Security - Electronic Data Capture (EDC): Hosts the EDC system in the cloud and provides data security 13 reviewers of TrialKit have provided feedback on this feature.
Role-Based User Permissions - Electronic Data Capture (EDC): Sets up and determines designated permission levels for users This feature was mentioned in 13 TrialKit reviews.
Query Management - Electronic Data Capture (EDC): Auto-generates or simplifies the manual addition of queries that require action in order to lock data This feature was mentioned in 13 TrialKit reviews.
Data Export - Electronic Data Capture (EDC): As reported in 13 TrialKit reviews. Eases the export of clinical data for tracking and reporting purposes

eCRFs - Electronic Data Capture (EDC): As reported in 13 TrialKit reviews. Facilitates the creation and storage of electronic case report forms and templates
Audit Trail - Electronic Data Capture (EDC): Tracks history of and any changes made to eCRFs or captured data This feature was mentioned in 13 TrialKit reviews.
Data Capture - Electronic Data Capture (EDC): Based on 13 TrialKit reviews. Provides 1 or more methods to electronically collect clinical trial data
Randomization - Electronic Data Capture (EDC): Manages patient enrollment and study randomization
Compliance - Electronic Data Capture (EDC): Ensures compliance with regulatory requirements like 21 CFR Part 11 This feature was mentioned in 12 TrialKit reviews.

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.

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.

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.