IBM Clinical Development solutions cover the entire study
Patient engagement (ePRO)
IBM provides ePRO technology that replaces conventional reporting methods and allows patients to share important information with caregivers at any time. With this immediate connectivity, typical overhead requirements are often unnecessary. Patient populations, once thought inaccessible, can now participate easily in timely studies. ePRO can be used via mobile devices or web entry.
The IBM data integration solution enables timely, automatic integration of data from diverse sources – minimizing data entry and maximizing study team efficiency. An established in-house training program teaches users to build studies and control data integration. Data is integrated directly into the multi-tenet SaaS solution for ease of access, stability and security that instills confidence in your trial data.
Reporting and analytics
IBM® Clinical Development lets you uncover fresh insights, patterns and relationships in your data that may be hidden. Create single-study and cross-study reports that help you draw better visual and logical conclusions across data sets and trials. Reporting options range from industry-standard reports to those that offer the latest advancements in analytics.
Quality and compliance
Safe Harbor and ISO-certified, IBM Clinical Development supports all GCP and associated regulations – including -21CFR Part 11 -EU GMP Annex 11. The platform meets all relevant FDA guidelines for software validation and computerized systems, including industry-standard encryption, enterprise-level firewalls, backup/disaster recovery, automatic archival and hosting in security-rich environments.
Directly integrated into IBM Clinical Development's EDC, all users access the same system. Users who perform medical coding can access electronic data capture for data review, queries and other study tasks. IBM Clinical Development offers medical coding features that go beyond stand-alone service – using trial data and management workflow to give users more power. Standard dictionary updates provide a complete and clear process for all coding procedures.
Site coordinators and adjudicators have immediate online access to content they need. With point-and-click logic, further development and programming are unnecessary, and users achieve full independence once adopted. At the click of a button, a dossier is compiled from all endpoint details and source documents. Endpoint cases progress through the entire adjudication process automatically. The system handles virtually any size study and essentially any number of sites and events.
Randomization and Trial Supply Management (RTSM)
Randomization and dispensing capabilities are designed, configured and updated quickly based on study requirements, without the need for programmers. One dashboard houses randomization and data capture needs so users don’t have to purchase expensive, customized connections. Stratify by data point, site, study or other criteria. This system provides real-time status of research inventory and helps to coordinate the entire tracking and dispensing process.