e-FORM

Managing clinical trials is a complex process that requires seamless coordination of multiple activities, strict adherence to regulatory guidelines, and efficient data management. e-FORM is designed to streamline every aspect of trial management, providing a centralized platform for research teams to collaborate, monitor, and report on trial progress in real time. Below are the key functions of e-FORM that empower organizations to run clinical trials more efficiently and effectively:

• Management and configuration of clinical trials
• Easy access to study data
• Clinical data entry directly from browser
• Management of errors and warnings on data entry
• Management of incomplete/unavailable/missing forms
• Conditional form filling
• Automatic and manual query management
• Use of dictionaries (MedDRA, ATC, ICD10, CTC, etc.)
• User management
• Site management
• Messaging management
• Calendar and visit reports
• Patient tracking
• CRF tracking
• Configuration of procedures for querying the data base
• Form generation and final CRF in PDF format
• Event history log
• Statistical analysis of events
• Audit trail
• Search functions (patients, visits, forms, variables, queries, …)
• Data export in various formats
• Statistical report management (study, patients, visits, forms, queries, centers, users)
• Descriptive statistics on variables
• Descriptive/graphic statistics on all variables in a form
• Data extraction via ad hoc queries (patients, forms, variables)
• Management of analysis laboratories and normal ranges
• Laboratory analysis unit converter
• Drug management and randomization
• Ad hoc reporting management
• Management of enrollment projections
• Geolocation management of trial centers
• Patient flowchart
• Configurable annotated CRF generation
• Management of events in diary
• Accounting of monitoring activities to centers
• e-PRO, e-Consent modules
• Clinical data import
• Source Data Verification (SDV)
• SAE Management
• Document Management
• Trial Master File Management
• Monitoring visits