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

Import and export data to and from software applications

Create, design and manage workflows for repetitive tasks

Track and manage adherence to policies for any service, product, process, or supplier

Tools to manage single or multiple clinical studies within a centralized platform

Store, manage, and track all electronic documents in a centralized location

Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws

Store, manage and track all forms in a centralized location

Manage and store data in a database

Define levels of authorization for access to specific files or systems

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

Receive data and information in real time

Capture data electronically

Uses decentralized resources such as network scanners, multi-function devices (MFD), and desktop scanners to collect data and documents

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.

Receive data and information in real time

Track and manage inventory levels to maintain proper supply

Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws

Track and manage schedules and meetings via an integrated calendar

Plan, manage, and track the financial activities of an individual or organization

Store, manage, and track all electronic documents in a centralized location

Manage user accounts, profiles, roles, permissions, and other details across applications, devices or networks

Tools to manage single or multiple clinical studies within a centralized platform

Create, design and manage workflows for repetitive tasks

Track and manage adherence to policies for any service, product, process, or supplier

Store, manage and track all forms in a centralized location

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.

Generate one-off reports that meet information requirements

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.

Application programming interface that allows for integration with other systems/databases

Plan availability and assign specific time slots for tasks and resources

Randomize the displayed order of questions and answer options

Electronic signing method that validates the authenticity and integrity of a digital document

Set & manage permission levels based on user roles and restrict access to only authorized individuals

Alter the layout and content of reports

Process of checking different types of data for accuracy to avoid errors or inconsistencies

Create and securely store digital patient records

Convert paper files into digital images

A virtual assistant that uses AI to pursue goals and complete tasks on behalf of users

Compliant with HIPAA, which sets standards for sensitive patient data protection

Graphical representation of data

Import, collect, and capture data from multiple sources

Manage the enrollment and onboarding of all new members and accepted applications

Collection, analysis, and representation of numerical data and generation of reports to understand various patterns

Observing and tracking a patient's health status, condition, and wellbeing

Define levels of authorization for access to specific files or systems

Helps clinical trials/labs get patients for participation.

Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges

Dashboard to view the status of ongoing processes, identify current incidents and track past activities

Set up connections to third-party platforms to improve business processes

Observe and track the demand, usage, progress or quality of a system, product, or user

Collect and track all case report forms (CRFs) within a centralized repository

Shows that electronic documents are authentic and linked to specific records

Data entry quality control method that involves recording the same data twice to maintain integrity

Track and document all activities across devices, networks, and other systems

Reporting on how each user, task or process has advanced since its initiation

Timed notification for any upcoming task, deadline, appointment, or activity

Synchronizing data between two or more devices/systems and automatically updating changes to maintain consistency

Import and export data to and from software applications

Store and organize documents in a centralized system

Use AI to generate content in the form of text, images, videos, etc.

Allows clinics and academic institutions to create trials and studies from scratch.

Customize contracts and forms to collect specific information

Assemble applications and processes by dragging over and arranging pre-built components

A record of all activities within the system, including user access, changes made, etc.

Active monitoring of systems, applications, or networks

Import, collect, and capture data from multiple sources

Securely stores data to prevent data loss or breaches

Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges

Web form that allows users to enter data that is sent and processed for different reasons

Manage the process of evaluating documents or requests submitted for approval

Configure existing workflows to meet your organization's needs

Active reporting of data and metrics

Digitally sign online documents

Access software remotely via mobile devices

Set up connections to third-party platforms to improve business processes

Assemble applications and processes by dragging over and arranging pre-built components

Ability of websites, web applications, or mobile applications to function without an active internet connection

Add customized logos and colors to align with company branding

Use AI to generate content in the form of text, images, videos, etc.

Convert paper files into digital images

Customize data fields to support various needs and use cases

A virtual assistant that uses AI to pursue goals and complete tasks on behalf of users

Customize contracts and forms to collect specific information

Store and organize documents in a centralized system

Import, collect, and capture data from multiple sources

Graphical representation of data

Synchronizing data between two or more devices/systems and automatically updating changes to maintain consistency

Process of checking different types of data for accuracy to avoid errors or inconsistencies

Compliant with HIPAA, which sets standards for sensitive patient data protection

Alter the layout and content of reports

A record of all activities within the system, including user access, changes made, etc.

View and track pertinent metrics to find patterns and gain insights from data

Pre-designed layouts that can be customized to match preferences and requirements

Assign categories, labels, tags, or attributes to documents for organization, search and storage

Automatically retrieve and pull information from documents, websites, images, data sets, and other sources

Application programming interface that allows for integration with other systems/databases

Electronic signing method that validates the authenticity and integrity of a digital document

Dashboard to view the status of ongoing processes, identify current incidents and track past activities

Manage and support multiple languages