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.

Important Features/Functionality:

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.