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Oracle InForm 6.1 is a market leading electronic data capture (EDC) system.
- The database design and user interface accommodate studies with multiple treatment arms and cohorts with different assessment schedules and frequencies. The system provides the ability to define multiple potential pathways a patient might take through a complex study and display only the relevant eCRF pages expected for the patient, based on reported patient data.
- Embedded data management workflows allow discrepancies to be managed efficiently by Data Managers. In InForm, the discrepancy data management capabilities provide systematic routing to specific study personnel.
- Sophisticated edit checks across all eCRF pages can be implemented for very complex studies.
- The need for source data verification can be defined at the CRF level to support risk based monitoring.
- Mid study protocol changes can be made without data migration, making it much easier to roll out the changes. Complete control over protocol amendments is provided. The rollout of amendments to sites can be carefully staggered and scheduled in accordance with local regulatory timelines. Study version assignments in InForm are specified per site and sites can be upgraded to new study versions on their own schedule. In Place Revisions can apply changes to all existing and new subjects.
- Images can be embedded into eCRFs.
- Outstanding reporting capability is provided. Standard reports include Audit Trail Reports, CRF Aging by Site, CRF Cycle Time Detail by Site, CRF Site Performance Summary by Site, CRF Status Detail by Site and Subject, CRF Status Detail by Visit and Site, CRF Status Summary by Site, CRF Status summary by User and many more! User defined reports are quickly configurable. There are over 150 operational reports, self served by the user. Preprogrammed operational?and clinical data models are provided
to build ad hoc reports, graphs, and charts with no technical experience required.
- The InForm Data Viewer Provides Actionable Insight. The user can assess and lock a site, multiple sites, or an entire trial in minutes. A data comparison tool reduces manual checks.
AE and Con Med comparison views simplify reconciliation. The user can
review trends across clinical or operational data,
easily view comments for clinical data and
export to Excel. This reduces programming support and allows for ad-hoc reporting on both operational AND clinical data without a delay or change order.
- New databases and eCRFs can be fully debugged in a Test Mode prior to committing them to Production Mode.
- Page elements can be saved in a Global Library for use on new studies. Study Templates can be created using objects from the existing library.
- Data is easily exported to SAS data sets for statisticians. This can support interim analysis.
- Built on powerful and robust Oracle technology, InForm has proven scalability and performance, having successfully supported thousands of clinical studies throughout the global clinical trial industry. These have included studies in all development phases and vast patient populations, with submissions approved across many therapeutic areas and geographies. InForm has been deployed in 5000+ trials to more than 100,000 sites.
- Medical coding with the latest MedDRA and WHO Drug dictionaries is fully integrated. Coding is automatic yet can be defined specifically for:
- therapeutic areas
- geographic regions
- Uses a state-of-the art Oracle 11g 64-bit database
- ClinDatrix performs dictionary upgrades annually under change control, thereby maintaining full validation of the system.
- A self-paced e-learning system is utilized for training clinical site personnel, sponsors and CRAs in the use of the system.