Easy clinical data review with Clinical Studio
Collecting clinical trial data is only part of the process. The Clinical Studio clinical data review features give you and your team the ability to review and audit subject records, keeping your study in compliance with regulations. Track all data being entered, changed, updated or deleted with complete audit trails.
Clinical data risk management
According to a report published by the FDA, effective clinical data risk management is critical to the protection of human subjects and the creation of high quality studies. Clinical Studio includes a risked-based monitoring feature that can aid researchers in the identification, analysis, mitigation or isolation of clinical research risks. This feature is designed to follow risk monitoring best practices and aligns with the FDA guidance to the industry on risk-based approaches to monitoring.
Query Management System
The process of reviewing data leads to questions and, in some cases, the need for clarification. Clinical Studio includes a fully integrated query management system that allows data managers to create and organize data queries. The Clinical Studio data management system can create automatic queries which are sent off to the appropriate role(s) at the appropriate site(s). Data managers can also enter manual queries as needed and get direct feedback from site coordinators.
Clinical Studio gives you the ability to:
- Create complete audit trails on subject records
- Create configurable subject records page
- Create interactive reports with daily action items
- Implement risk-based monitoring (RBM) best practices
- Create, respond to, or close queries instantly with the Query Management System via web or conveniently with the mobile app