[ Clinica... Reviews ](https://www.g2.com/products/clinical-research-suite/reviews) [ Clinica... Reviews ](https://www.g2.com/products/clinical-research-suite/reviews) # Clinical Research Suite Features ##### ## Data Management (13) Cloud Security - Electronic Data Capture (EDC) Hosts the EDC system in the cloud and provides data security Role-Based User Permissions - Electronic Data Capture (EDC) 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 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 Show More ##### ## Clinical Study Support (8) eCRFs - Electronic Data Capture (EDC) 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 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 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 Show More ##### ## 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 Show More ##### ## 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 Show More ##### ## 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. Show More ##### ## 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. Show More ##### ## Document Management (4) 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. Show More ##### ## Product Management (5) 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. Show More ##### ## Regulatory Affairs (4) 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. Show More ##### ## 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 Show More ## 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