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Next-Generation BA/BE Clinical Management

Zentixs Vista is the comprehensive eClinical platform designed specifically for Clinical Research Organizations managing Bioavailability, Bioequivalence, and Phase 1 studies with healthy subjects.

Zentixs Vista UI

40%

Faster Study Setup Time

99.9%

Protocol Deviation Reduction

150k+

Healthy Subjects Managed

100%

21 CFR Part 11 Compliant

Comprehensive BA/BE Modules

An integrated suite designed to handle every aspect of clinical pharmacology and BA/BE trials with absolute precision and regulatory adherence.

Subject Screening
Subject Screening

Manage volunteer databases, track medical histories, and automate screening workflows for healthy subjects with integrated eligibility checks.

Electronic CRF (eCRF)
Electronic CRF (eCRF)

Build complex case report forms visually. Capture clinical data in real-time with automated edit checks and source data verification tools.

Pharmacokinetics (PK)
Pharmacokinetics (PK)

Integrated modules for capturing, processing, and analyzing PK sample data seamlessly, connecting lab results directly to subject profiles.

Clinical Scheduling
Clinical Scheduling

Automated dosing and sampling schedules. Prevent protocol deviations with real-time alerts for clinical staff during study execution.

IP Inventory & Dispensing Activities
IP Inventory & Dispensing Activities

Tracks investigational product stock levels, records dispensing to subjects, and manages accountability of study drugs throughout the trial.

Adverse Event & Safety Reporting
Adverse Event & Safety Reporting

Captures, documents, and escalates adverse events or safety findings observed during the trial in compliance with regulatory reporting requirements.

Sample Tracking & Deviation
Sample Tracking & Deviation

Monitors the collection, labeling, and chain of custody of bioanalytical samples, while logging any protocol deviations related to sampling procedures.

Subject Check-in & Check-out
Subject Check-in & Check-out

Handles subject arrival and departure workflows for study visits, including confirmation of scheduled activities and time-stamped attendance records.

Protocol Design
Protocol Design

Collaborative study design tools allowing medical writers to map out cross-over, parallel, or replicate BA/BE study designs efficiently.

Deep dive into Zentixs Vista capabilities

Explore the four core pillars that make up the most comprehensive clinical software suite for BA/BE research.

Healthy Subject Registry & Recruitment

Maintain a high-quality, reliable pool of healthy volunteers. Protect subject safety and ensure protocol compliance before the trial even begins.

Biometric Authentication & Washout Tracking

Biometric Authentication & Washout Tracking

Integrate fingerprint scanners to verify subject identity instantly. Automatically calculate washout periods and block ineligible enrollment.

Quality Assurance

Quality Assurance

Built-in CAPA management, automated audit trails, and digital signatures to ensure strict adherence to FDA and EMA guidelines.

Dynamic Screening Questionnaires

Dynamic Screening Questionnaires

Build custom medical history and eligibility forms with automated subject flagging based on lab results and criteria.

Healthy Subject Registry Recruitment
Healthy Subject Registry Recruitment

Clinic Floor Execution

Digitize your clinic floor. Replace clipboards and stopwatches with ruggedized tablets, barcode scanners, and automated device integration.

Barcode-Driven IP Administration

Barcode-Driven IP Administration

Scan the subject's wristband, scan the investigational product, and confirm dosing time. The system guarantees the right drug for the right subject in the right sequence.

PK/PD Sample Scheduling & Alarms

PK/PD Sample Scheduling & Alarms

Generate precise, minute-by-minute schedules for phlebotomists based on actual dosing times. Visual and audible alarms alert staff to upcoming critical timepoints.

Direct Medical Device Integration

Direct Medical Device Integration

Capture vitals (BP, Heart Rate, Temp) directly from connected monitors into the eCRF via API, eliminating manual transcription errors and speeding up data collection.

Bioanalytical LIMS Integration

Bridge the gap between the clinical unit and the bioanalytical laboratory. Track samples from the subject's arm to the analytical instrument.

Centrifuge & Aliquot Tracking

Centrifuge & Aliquot Tracking

Track the entire processing lifecycle of a sample. Record centrifuge parameters, separation times, and generate child barcodes for multiple aliquots automatically.

Deep Freezer Management

Deep Freezer Management

Virtual freezer mapping allows lab technicians to visually locate samples. Track freeze-thaw cycles and integrate with temperature monitoring systems for excursion alerts.

Shipment Manifest Generation

Shipment Manifest Generation

Create digital shipment manifests with one click. When samples arrive at the sponsor or central lab, they can be batch-scanned for instant reconciliation.

Healthy Subject Registry Recruitment

Why standard EDCs fail in BA/BE Trials

Generic electronic data capture systems are built for long-term Phase III oncology trials, not the rapid-fire, high-volume operational demands of a Phase I clinic floor.

The Industry Challenge

Fragmented Systems

Using separate tools for recruitment, screening, EDC, and bioanalytical LIMS leads to massive data reconciliation efforts.

Manual Clinic Operations

Paper CRFs and manual vital/dosing logs result in missed time points, illegible entries, and protocol deviations.

Volunteer Cross-Participation

Inability to track healthy subjects across multiple studies risks volunteer safety and invalidates study data.

The Zentixs Vista Solution

Deep Freezer Management

A single database from recruitment to final CDISC export. Data is entered once and flows seamlessly across modules.

Digital Clinic Floor

Barcode-driven dosing, automated PK sampling alarms, and direct integration with medical devices to ensure 100% accuracy.

Biometric Subject Registry

Fingerprint or facial recognition integrated with a central database to enforce washout periods automatically.

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Promising Regulatory Compliance

Zentixs Vista is engineered to withstand the most rigorous audits from the FDA, EMA, and global health authorities. Your data is always inspection-ready.

21 CFR Part 11 21 CFR Part 11
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Secure Electronic Signatures

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Time-stamped, unalterable audit trails

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System timeouts and forced re-authentication

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Granular role-based access control (RBAC)

CDISC Data Standards CDISC Data Standards
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Native CDASH compliant forms

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Automated SDTM dataset generation

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Controlled terminology dictionaries

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Ready for regulatory e-submissions

Data Security & Privacy Data Security & Privacy
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HIPAA & GDPR compliant infrastructure

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AES-256 encryption at rest and in transit

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ISO 27001 certified cloud hosting

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Automated backup and disaster recovery

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Frequently Asked Questions

BA/BE clinical management software helps CROs manage subject screening, dosing, sampling, PK data, scheduling, and study documentation in one system.
Automated schedules, sampling alerts, eligibility checks, and notifications help prevent missed activities and timing errors.
It centralizes healthy subject records, eligibility checks, biometric identification, and washout-period tracking.
Yes, it connects clinical workflows with bioanalytical LIMS processes for traceability from sample collection to analysis.
It supports electronic signatures, audit trails, role-based access, time-stamped records, and secure authentication.
It reduces manual data entry, connects workflows, improves study visibility, and enables faster, more reliable trial execution.