Zentixs Vista is a comprehensive BA/BE clinical trial management software (CTMS) built for Contract Research Organizations (CROs) managing Bioavailability, Bioequivalence, and Phase 1 studies with healthy subjects.
Faster Study Setup Time
Protocol Deviation Reduction
Healthy Subjects Managed
21 CFR Part 11 Compliant
Zentixs Vista is an end to end clinical trial management platform designed for organizations conducting and supporting Bioavailability, Bioequivalence and Phase I studies.
Manage healthy volunteer registration and screening, study and protocol activities, randomization, clinical assessments, dosing, investigational products, PK sample collection, bioanalytical workflows, clinical data, statistical analysis and reporting through one connected platform.
Everything you need to manage the complete BA/BE and Phase I clinical research lifecycle in one connected platform.
Manage complete volunteer information and participation records from registration through study completion.
Capture demographic details, photographs, signatures and registration information.
Support biometric registration, IRIS scanning, wristbands and digital identity verification.
Generate volunteer IDs, barcodes and QR codes for reliable identification.
Maintain centralized volunteer profiles with participation and eligibility history.
Track volunteer status, eligibility and participation across studies.
An electronic data capture system is primarily designed to collect and manage clinical data.
BA/BE studies involve a broader operational lifecycle.
Volunteer eligibility must be established.
Subjects must be enrolled and assigned to treatment sequences.
Dosing must follow defined study conditions.
PK samples must be collected at specified time points.
Samples must remain traceable through processing, storage and shipment.
Bioanalytical results must be reconciled with clinical information.
PK parameters must be generated and reviewed.
Study data must be finalized, analyzed and reported.
Manage volunteer attendance, movement and participation throughout the study lifecycle with complete traceability.
Record study-site reporting and departure times with accurate attendance.
Track ambulatory and post-study visits with check-in, check-out and attendance records.
Manage volunteer transfers between studies or sites and record dropout status with reasons.
Temporarily block a volunteer or subject from study activities when required.
Upload signed informed consent forms and supporting documents against each volunteer.
Track compensation-related attendance for volunteers and subjects throughout the study.
Connect study-site devices to support volunteer identification, attendance and operational workflows.
From volunteer registration to final archiving, every stage follows a connected and controlled workflow.
Vista brings together operational information to provide a broader view of study progress.
Zentixs Vista is engineered to withstand the most rigorous audits from the FDA, EMA, and global health authorities. Your data is always inspection-ready.
Secure Electronic Signatures
Time-stamped, unalterable audit trails
System timeouts and forced re-authentication
Granular role-based access control (RBAC)
Native CDASH compliant forms
Automated SDTM dataset generation
Controlled terminology dictionaries
Ready for regulatory e-submissions
HIPAA & GDPR compliant infrastructure
AES-256 encryption at rest and in transit
ISO 27001 certified cloud hosting
Automated backup and disaster recovery