Clinical Trials
InfoEd’s Clinical Trials module brings order to the complex world of human studies. The system combines comprehensive standalone functionality with built-in integration to InfoEd’s other software solutions so trials can be linked in meaningful ways to related protocols, grants or contracts, publications, and patents. With InfoEd institutions can phase out disjointed legacy applications and paper-based processes and replace them with a single browser-based application that facilitates collaboration between the research personnel that support all the various aspects of a trial.
- Centralized trial database facilitates system consolidation, improved data integrity, and shared access.
- Browser-based module provides a unifying online hub for collaborative trial management allowing individuals to contribute from either Macs or PCs from on and offsite.
- Capture all trial information in a single study record (e.g. personnel; sponsor contacts; trial design; visit schedule; protocol approvals; financials; enrollment activity; etc.).
- User-friendly interface with field level help, links to product manuals, and integrated email support.
- Add any number of user-defined fields (e.g. pick lists; check boxes; radial buttons; text boxes; and numeric fields) to any page in the Clinical Trails module to accommodate unique institutional requirements.
- Code all administrative details (e.g. sponsors; procedures; populations; methods; locations; centers; keywords; etc.) using normalized look-up tables for meaningful cross-study reporting.
- Upload supporting documentation (e.g. investigator brochures; study protocols; case report forms; agreements; etc.).
- InfoEd’s ad hoc Reporting Tool provides access to all fields in all records, enabling customizable views of the data on demand. The module can export data in SAS format, and is also ODBC compliant for data exports to 3rd party statistical analysis packages and institutional data warehouses.
- Clinical Trials module leverages the InfoEd platform’s central contact management system. Communication history is maintained both centrally at the contact profile level, as well as discretely within each record.
- Clinical Trials provides for links with other InfoEd modules, enabling tight coordination with other research offices on related grants, protocols, and agreements.
- The status of all office records can be viewed at a glance via InfoEd’s Workflow Manager.
- Workflow security enables the flexible division of administrative functions between distinct areas of operation (e.g. trial design; contract administration; participant management; etc.).
- Access to trials is highly controlled. By default researchers only have access to those studies to which they are directly associated. Individuals with departmental or central management roles can be granted access to all trials in their area.
- User activity is tracked at the system, record, and field level. Change history is available on demand.
- Clinical Trials can capture the status and high-level details of all associated protocol reviews. The module is tightly integrated with the InfoEd Human Subject module, allowing changes in protocol status to seamlessly update linked studies.
- Adverse Event Reports are tracked as independent submission objects within the Clinical Trials module, They can be batch associated to multiple protocols based on the event’s attributes (e.g. PI, drug, method, procedure, sponsor, etc.).
- The system can track the status, terms and conditions, documents and communication history of every agreement related to a trial.
- The system can track the inventory of study drugs within each trial. The trial design can account for use on a per visit basis. As clinicians record visits, the inventory counts are automatically decremented, which can in turn trigger alerts based on pre-defined minimums.
- Flexible study binder for uploading important trial related documentation (e.g. investigator brochures, 1572s, consent forms, certifications, logs; etc.) facilitates regulatory compliance.