Clinical Research Suite Features

Hosts the EDC system in the cloud and provides data security

Sets up and determines designated permission levels for users

Auto-generates or simplifies the manual addition of queries that require action in order to lock data

Eases the export of clinical data for tracking and reporting purposes

Facilitates the creation and storage of electronic case report forms and templates

Tracks history of and any changes made to eCRFs or captured data

Provides 1 or more methods to electronically collect clinical trial data

Manages patient enrollment and study randomization

Ensures compliance with regulatory requirements like 21 CFR Part 11

Provides oversight on site-specific details, participation status, enrollment planning, and site communications.

Coordinates, tracks, monitors, and manages participants enrolled in upcoming or ongoing clinical trials.

Consolidates and centralizes study-relevant data and information.

Gathers and collects contact information for trial participants.

Coordinates, tracks, monitors, and manages upcoming or ongoing clinical trials.

Records and administers study- and site-specific documents, forms, and activities.

Enables continuous and up-to-date reporting during studies.

Allows customization of study's key dates; tracks deadlines and milestones; issues progress reports.

Offers customizable dashboards and analytics to track completeness, compliance, quality, and timeliness of the study.

Offers a pre-built DIA TMF reference model hierarchy, and allows for configurable reference models to meet the specific needs of organizations and sponsors.

Supports inspections and regulatory audits by maintaining inventory and document reports, and having pre-built compliance with all relevant regulatory guidelines.

Designates customizable user roles and limit access to certain functions in the eTMF.

Allows users to upload multiple documents at once and provides dynamic indexing options.

Manages the status of all trial documentation at all stages and flags missing documentation.

Tracks each version of a document and shows changes from each version or reupload.

Allows documents and metadata to be easily searched within the system.

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.

Allows external or remote contributors to upload documents and work collaboratively in a controlled method.

Configures review, e-signature, and approval workflows for all documentation.

Tracks submissions plans for products to report against milestones and progress. Streamlines the entire dossier lifecycle and tracks the status of all submissions.

Supports the creation of technical files and essential principles checklists.

Provides templates and tools to create all planned regulatory content for a product.

Stores all previously submitted documents for use in audits or future submissions.

Enables traceability into the entire pre- and post-market lifecycle to monitor milestones, time to completion, and updates and approvals.

Prepares and submits labels and UDI submissions for products, validated accordingly to regional regulatory requirements.

Maintains up-to-date dashboards for overseeing every task, deadline, project status, and workflow.

Allows multiple users to collaborate on documents and flag errors or updates.

Centralizes and tracks detailed product information, such as registration status and selling status for each location and market.

Tracks key deadlines for submissions, renewals, and audits, and streamlines the document retrieval process for each activity.

Streamlines post-market product data collection and analysis for safety, sentiment, and future product improvements.

Fields internal team and external agency messages or tickets related to regulatory concerns, and inboxes all correspondences.

Connects to regulatory databases and market sources to monitor upcoming changes that may impact product selling status.