Clincase

Clincase is a clinical trial software company that develops an all-in-one e-clinical technology suite designed to support the data collection, management, and reporting needs of clinical trials. The platform is built to handle complex and challenging studies while meeting regulatory requirements, and it serves sponsors, contract research organisations (CROs), data managers, investigators, and study participants across more than 20 countries.

The Clincase suite provides a developer-centric programming interface alongside tools for investigators and data managers, covering the full lifecycle of clinical data from collection through processing, review, and reporting. The platform has been used in over 400 studies involving more than 100,000 subjects, and is rated 4.6 out of 5 on G2.com. AMS Advanced Medical Services GmbH, a mid-size full-service CRO, has used Clincase as its standard EDC system since 2010.

Core Modules and Products

• Electronic Data Capture (EDC): Collects, manages, and stores real-time clinical study data, supporting efficiency and regulatory compliance.
• ePRO: A patient-centric electronic patient-reported outcomes solution that facilitates submission of data by study participants.
• eCRF Design: Provides user-friendly templates and supports easy creation and modification of electronic case report forms using a scripting language.
• Randomization and Trial Supply Management (RTSM): Manages medication supply and allocation through a versatile workflow, with seamless eCRF integration, unlimited stratification parameters, and block randomization.
• SAE Functionality: Supports high-efficiency and accurate adverse event and serious adverse event reporting.
• API Integration: Enables remote acquisition of data from wearable devices, health applications, and clinical trial management systems (CTMS).
• Data Visualization: Offers self-configurable reports and dashboards for monitoring study progress and supporting decision-making.
• Alerts and Notifications: Delivers customizable alerts with configurable content and trigger conditions directed at target audiences.

Build, Maintenance, and Design Capabilities

• A powerful eCRF design environment that supports trials with complex protocol requirements.
• Automation, scripting, and API tools intended to support data managers in building and maintaining studies.
• A hybrid project management methodology used during EDC implementation, blending structured processes with flexibility to align system configurations with operational workflows.

Trial Control and Monitoring

• Metrics reporting for monitoring trial progress, efficiency, and data quality.
• Full audit trail covering all user actions within the system.
• Online visualisation of study participant status and data previews.

Compliance and Regulatory Standards

• Compliant with FDA 21 CFR Part 11, EU GMP Annex 11, ICH-GCP, and GDPR requirements.
• Includes a comprehensive software validation package.

Usability and Accessibility

• Designed with an easy-to-learn interface for both investigators and study participants.
• Compatible across browsers, smartphones, tablets, and desktop computers.
• Optionally includes an eLearning module available for the duration of a study, which is noted as useful when there are changes in site staff.

Integrations and Interoperability

• Supports ICH E2B, MedDRA, and WHODD encoding standards.
• API connectivity for synchronisation with medical applications, CTMS platforms, and wearable devices.

Clincase positions itself as a platform suited to mid-sized CROs and sponsors managing operationally complex trials, with a focus on configurability, regulatory compliance, and cross-device accessibility.