Clincase EDC
Empowering Precision and Efficiency through Data Management Transformation
Our approach delivers unparalleled end-user experiences, enabling seamless data collection and validation, dynamic data visualization, effortless monitoring, and robust data extraction and analysis for unrivaled insights
Enabling Clinical Trials with Advanced EDC and Data Management Capabilities
Comprehensive EDC and Clinical Data Management Solution: Clincase is a powerful EDC and clinical data management solution that enhances control over the clinical trial process. It provides a comprehensive range of features and functionalities to streamline the collection and management of clinical trial data.
Extensive Usage and Industry Adoption: Clincase is widely adopted in pharmaceutical and biotech industries, utilized in Phase I-IV trials. It's used by organizations globally, including CROs, research centers, and university hospitals in Europe, the U.S., and Asia. It has been deployed in 400+ studies, documenting data for 100,000+ subjects.
Adaptation to Regulatory Landscape and Enhanced Data Collection: Clincase has adapted to evolving regulatory requirements, integrating advanced reporting and data visualization features. The added capabilities of Clincase empower users to implement strategic and risk-based approaches in their clinical trials.
Clincase simplifies EDC, making data management easier and more efficient
Ease of
Use
The user interface is intuitive, easy to navigate and requires minimal training. It incorporates clear and concise icons, and interactive elements that guide users through each step, ensuring a smooth and efficient workflow.
Configuration
& Integration
Clincase is configurable to support the study requirements, including the use of electronic signatures, data export formats and assignment of tasks and workflows to user groups.
Quick &
Easy Access
Accessible from multiple devices and locations, allowing users to enter data from anywhere with an internet connection.
Essential and robust EDC features at your disposal
The foundation lies in exceptional eCRFs
Our core system combines flexible EDC and eCRF functionalities while seamlessly integrating ePRO questionnaires for efficient data collection.
No data import/export or compatibility worries. Our Modules are seamlessly integrated with EDC, designed for a cohesive workflow from the start.
Streamlined Workflow and Simplified Data Capture with Clincase
Our solution prioritizes simplicity and efficiency, streamlining setups for desired outcomes.
Clincase seamlessly handles real-time calculations and field dependencies. Data is automatically saved when you leave a field, removing the need for manual saving. Our Edit Checks feature simplifies query management with a single query. Clincase also excels in mapping various trial types and page structures.
Guided Workflow System: Seamlessly Navigating UsersCollection Through Each Step
User-Friendly Interface with Intuitive Design for Enhanced User Experience.
Based on your user role, you will be guided to the next action, such as signing data, resolving queries, or completing missing data for investigators. For monitors, this may involve performing SDV or selective/targeted SDV. Data managers, on the other hand, are responsible for reviewing data and closing queries. Additionally, they may visualize key data for the clinical team.
Compliant Electronic Signatures and Comprehensive Audit Trail Functionality
Compliant, Secure, Transparent, Streamlined.
Clincase ensures compliance with FDA 21 CFR part 11 through electronic signatures. Signature fields can be defined at different levels in the study metadata, with associated roles and meanings. Password authentication is required for any signature changes. Clincase also provides a detailed audit trail for tracking modifications at various levels.
Study amendments & eCRF changes
Make changes in a controlled way, but without big time delays
Protocol amendments lead to eCRF changes, and Clincase simplifies this step for data managers and eCRF designers, making it easier and more efficient to update and implement the necessary modifications.
Compliance
Clincase is compliant with good practices and regulatory requirements for clinical trials such as ICH GCP, HIPAA, 21CFR part 11 and FDA, EMA, NMPA, PMDA
Everything you’d expect + more
Powerful Form Builder
Simple drag-and-drop plus powerful scripting language, Edit Checks, and constraints
Forms & Organization
Organize the form structure to build an intuitive eCRF
SDV + RBM
Real-time data and SDV flagging workflows enable risk-based monitoring.
Flags, Comments, Queries
Everything you need to enable collaborative study workflows
50+ Standard Reports
Spend less time creating the basics by using our standard reports
Data Visualization
Online data preview and chart visualization of your key metrics
Audit Trail
Complete audit trail of all data changes and user actions
User Management
Flexible and complete control over visibility and access management
PDF creation
Complete copy of eCRF to PDF including audit trail, queries and workflow flags
Essentials
Audit Trail
User Roles & Access
eSignatures
Data Security
Data Export
Training
Integrated Modules
Optional ePRO solution
eLearning
AE/SAE notifications
IWRS / Supply Management