CODELISA is a web based electronic data capture system which increases process efficiencies at various stages of bioequivalence studies. It is designed to streamline processes included in clinical trial by replacing traditional paper-based process. It is a closed system, fully validated, 21 CFR part 11 compliant, meeting GCP and other applicable regulatory requirements.
Different modules/process flows are - Admin, Volunteer Registration, Screening and Clinical lab currently. All the modules/process flows are linked internally with each other and are interfaced with other software/devices as applicable for the necessary data capture and its management.
Clinical – Early phase study conduction process are under development phase.
Admin module :
- Administrative functionality like access inside/outside Cliantha premises, user management, role management, master management, and password policy & authentication process.
Volunteer Registration module :
- Functionality for biometric (IRIS) verification and registration
- Centralized database for registered volunteers with unique volunteer ID generation facility
- Maintain volunteer track history (screening status, Project participation, Adverse event, Discontinuation details, next study eligibility, etc.) and volunteer blocking to avoid cross participation
- Dynamic option to search volunteer by using different criteria
Screening Module :
- Functionality to perform screening activities like demographic details, medical examination, lab test requisition, collection, lab report evaluation, etc. through wrist band barcode verification
- Online ECG and X-ray evaluation for physician
- Online tracking of screening activities at each stage
- Multiple document upload facility
- Maintain substances history like alcohol consumption, tobacco, etc.
- Project configuration facility to extract eligible volunteer according project set criteria (e.g., like BMI, Age criteria)
- Screening blocking facility for all dosed volunteers
- Extraction facility Medical Screening Record (MSR) for study data compilation and submission.
- Dynamic provision for screening data extracting facility for multi-purpose use like quick data review, study report tables preparation and CDISC dataset preparation
- Each screening activity data transcription facility
- Different screening and project specific report view with dynamic filters
Clinical Lab Module :
- Integrated with clinical lab software for online reviewing lab results
- Lab sample collection process through barcode verification
- Facility to transfer /outsourced lab test to another lab
- Lab data release process from Clinical lab software to CodeLisa through controlled and secure process
- Online tracking of lab test result status
Audit trails :
- Module wise audit trails data view facility with dynamic search options
- Activity specific audit trail facility for easy view.