Clinical Research Suite Features

Data Management (4)

Cloud Security - Electronic Data Capture (EDC): Hosts the EDC system in the cloud and provides data security 48 reviewers of Clinical Research Suite have provided feedback on this feature.
Role-Based User Permissions - Electronic Data Capture (EDC): As reported in 50 Clinical Research Suite reviews. Sets up and determines designated permission levels for users
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 49 Clinical Research Suite reviews.
Data Export - Electronic Data Capture (EDC): Eases the export of clinical data for tracking and reporting purposes 48 reviewers of Clinical Research Suite have provided feedback on this feature.

eCRFs - Electronic Data Capture (EDC): Facilitates the creation and storage of electronic case report forms and templates 49 reviewers of Clinical Research Suite have provided feedback on this feature.
Audit Trail - Electronic Data Capture (EDC): Based on 48 Clinical Research Suite reviews. Tracks history of and any changes made to eCRFs or captured data
Data Capture - Electronic Data Capture (EDC): Provides 1 or more methods to electronically collect clinical trial data 49 reviewers of Clinical Research Suite have provided feedback on this feature.
Randomization - Electronic Data Capture (EDC): Manages patient enrollment and study randomization 50 reviewers of Clinical Research Suite have provided feedback on this feature.
Compliance - Electronic Data Capture (EDC): Ensures compliance with regulatory requirements like 21 CFR Part 11 49 reviewers of Clinical Research Suite have provided feedback on this feature.

Site Management: Based on 132 Clinical Research Suite reviews. 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. 132 reviewers of Clinical Research Suite have provided feedback on this feature.
Data Centralization: Based on 130 Clinical Research Suite reviews. Consolidates and centralizes study-relevant data and information.
Contact Management: Gathers and collects contact information for trial participants. 126 reviewers of Clinical Research Suite have provided feedback on this feature.

Project Management: Coordinates, tracks, monitors, and manages upcoming or ongoing clinical trials. 131 reviewers of Clinical Research Suite have provided feedback on this feature.
Documentation: Records and administers study- and site-specific documents, forms, and activities. 131 reviewers of Clinical Research Suite have provided feedback on this feature.
Reporting: Enables continuous and up-to-date reporting during studies. 131 reviewers of Clinical Research Suite have provided feedback on this feature.
Milestones Management: Allows customization of study's key dates; tracks deadlines and milestones; issues progress reports. 126 reviewers of Clinical Research Suite have provided feedback on this feature.

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.

Dossier Management: Tracks submissions plans for products to report against milestones and progress. Streamlines the entire dossier lifecycle and tracks the status of all submissions.
Tech Files: Supports the creation of technical files and essential principles checklists.
Submission Planning: Provides templates and tools to create all planned regulatory content for a product.
Archiving: Stores all previously submitted documents for use in audits or future submissions.

Audit Trails: Enables traceability into the entire pre- and post-market lifecycle to monitor milestones, time to completion, and updates and approvals.
Label Management: Prepares and submits labels and UDI submissions for products, validated accordingly to regional regulatory requirements.
Live Dashboards: Maintains up-to-date dashboards for overseeing every task, deadline, project status, and workflow.
Collaborative Authoring: Allows multiple users to collaborate on documents and flag errors or updates.
Product Information: Centralizes and tracks detailed product information, such as registration status and selling status for each location and market.

Automated Notifications: Tracks key deadlines for submissions, renewals, and audits, and streamlines the document retrieval process for each activity.
Post-Market Surveillance: Streamlines post-market product data collection and analysis for safety, sentiment, and future product improvements.
Communication Tools: Fields internal team and external agency messages or tickets related to regulatory concerns, and inboxes all correspondences.
Regulatory Intelligence: Connects to regulatory databases and market sources to monitor upcoming changes that may impact product selling status.