Clinical Data Management
You shouldn’t have to be an Oracle database programmer to use your EDC solution. The diverse range of EDC users, from registered nurses to data managers to a VP Clinical, requires a solution that can manage data simply, as well as be deployed in multiple clinical environments.
Whether it’s a small Phase I study, or a large international post-marketing registry, ClinicalAnalytics 4.0 provides easy-to-use features that enable sponsors and CROs to automate the management and validation of their data on demand. This allows you to review, identify and approve data across sites, trials and global locations in real-time, on demand.
Using permission-based rules, ClinicalAnalytics 4.0 enables users to code with standard or custom dictionaries and to utilize configurable reporting and query tools. With an intuitive browser interface, ClinicalAnalytics 4.0 eliminates the need to hire expensive database experts. All your organization needs is access to a Web browser.
Clinical Data Management Features:
Post Data Entry (PDE) Validation enhances the accuracy of data across multiple forms and subjects based on a study’s configuration and associated data rules. The feature simplifies and accelerates the validation of data and ensures that it is consistently managed.
Dictionary Management automates the administration of MedDRA and WHODrug Dictionaries, which enables users to access, release and maintain coded records of patient safety data.
Industry Standard Data Export uses an easy-to-use wizard to export data to Excel, SAS and SPSS for analysis or a custom report design.
Interactive Discussion Forumprovides a secure platform to post messages and share documents from multiple sites. With read, access and edit permissions, data managers can create groups and sub-groups with select access to available documents and discussion areas.
Integrated Data Clarification Form (DCF) Managementaccelerates and streamlines data cleaning. Users can raise, clarify, interact, log resolution and audit DCFs.
Source Data Verification (SDV) Tracking records and audits SDV signature and dates after it has been completed.
Electronic Signature accounts for electronic signature and dates for the completion and accuracy of eCRF form data. Permitted users utilize controls to identify eligiblibility for electronic signatures.
Document Generation configures event-driven document generation to produce documents reporting Adverse Events, CIOMS and Medwatch data.
