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Digitize Preclinical Studies
with Confidence.

Zentixs Spera centralizes preclinical data capture, validation, and regulatory reporting in one intelligent platform. From protocol-driven eCRFs to automated FDA SEND submissions, every step is designed for accuracy, efficiency, and compliance.

Why Zentixs Spera?

Preclinical studies generate thousands of observations across multiple departments — animal facilities, clinical observations, pathology, bioanalysis, and toxicology. Managing this data manually leads to inconsistencies, transcription errors, delayed reporting, and complex regulatory submissions.

Zentixs Spera provides a centralized platform for collecting, validating, reviewing, and reporting study data according to the approved study design and regulatory standards.

19+

Supported SEND
Domains

10

Study Phases
Covered

21 CFR

Part 11
Compliant

100%

Protocol-Driven
Forms

Complete Study Data Collection Platform

Collect standardized data from every study phase, treatment group, and scientific domain while maintaining complete traceability and regulatory compliance.

Protocol-Driven Data Collection

Automatically generate data collection forms based on study protocol, design, animal groups, dose levels, and study schedule. No manual form creation required.

  • Study Protocol
  • Animal & Treatment Groups
  • Dose Levels
  • Study Days & Time Points

Phase-Based Data Collection

Capture observations according to each study phase with configurable forms, validations, and approval workflows.

  • Acclimatization
  • Pre-Dose & Treatment
  • Necropsy & Histopathology
  • Statistical Analysis

Domain-Based Data Collection

Collect structured data across all scientific domains following standardized templates with configurable fields.

  • Body Weight & Clinical Signs
  • Hematology & Chemistry
  • Toxicokinetics
  • Bioanalysis

Data Validation & Review

Improve data quality using built-in validation including range checks, duplicate detection, outlier identification, and cross-domain validation.

  • Range Checks
  • Missing Data Alerts
  • Query Management
  • Reviewer Comments

Real-Time Study Progress

Monitor data collection activities across every study with a live dashboard showing completion rates, pending forms, review status, and locked records.

  • Data Completion %
  • Pending Forms
  • Domain & Phase Completion
  • Review Status

Configurable Electronic Forms

Design eCRFs without programming. Supports dynamic forms, conditional fields, validation rules, calculated fields, and electronic signatures.

  • Dynamic & Conditional Fields
  • Validation Rules
  • Calculated Fields
  • Electronic Signatures

Every Phase. Every Domain. Every Animal.

Comprehensive coverage across all preclinical study components — from acclimatization through histopathology and regulatory submission.

Supported Study Phases

  • 1 Acclimatization
  • 2 Pre-Dose
  • 3 Treatment
  • 4 Clinical Observation
  • 5 Sample Collection
  • 6 Recovery
  • 7 Necropsy
  • 8 Histopathology
  • 9 Statistical Analysis
  • 10 Report Preparation

Data Domains

DemographicsAnimal AssignmentBody WeightFood ConsumptionClinical SignsDosingSample CollectionClinical PathologyHematologyClinical ChemistryUrinalysisToxicokineticsOrgan WeightNecropsyHistopathologyBioanalysisEnvironmental MonitoringDeviationsStudy Events

Treatment Groups

  • Control Group
  • Vehicle Control
  • Low Dose
  • Mid Dose
  • High Dose
  • Recovery Groups
  • Satellite Groups
  • Toxicokinetic Groups

Animal-Centric Tracking

Animal IDCageGroupStudy DayDoseClinical Obs.Lab ResultsNecropsy Findings

Automated SEND Dataset Generation

Automatically transform collected study data into SEND-compliant datasets for regulatory submission — validated and ready for FDA review.

Supported SEND Domains

DMDemographics
TDTrial Design
TSTrial Summary
EXExposure
BWBody Weight
CLClinical Observations
LBLaboratory Data
EGElectrocardiography
PFPathology Finds

SEND Validation

  • SDTM SEND Compliance Checks
  • Controlled Terminology Validation
  • Dataset Structure Validation
  • Variable Validation
  • Metadata Validation
  • Define.xml Generation
  • Pinnacle 21 Readiness

Zentixs Spera Integrates with

Empowering diverse industries with tailored digital solutions, scalable technology, and results-driven innovation.

Zentixs Labs
Zentixs Labs
Zentixs Labs
Zentixs Previa
Zentixs Vizenta
Zentixs Docs
Zentixs Caliber
Zentixs Elina
Zentixs Sign
Zentixs Labs
Zentixs Previa
Zentixs Vizenta
Zentixs Docs
Zentixs Caliber
Zentixs Elina
Zentixs Sign

Regulatory Reporting

Generate comprehensive reports at every level — from individual animal observations to complete regulatory submission packages, all in inspection-ready formats.

  • Individual Animal Reports
  • Treatment Group Reports
  • Clinical Observation Reports
  • Body Weight Trends
  • Laboratory Results
  • Pathology Reports
  • Toxicology Summary
  • SEND Packages
  • Regulatory Submission Reports
  • Final Study Reports

Report Generation

Final Study Report
Ready
SEND Package
Ready
Body Weight Trend
Ready
Pathology Report
Pending

Built for Speed, Compliance & Confidence

shield
FDA SEND Standard
shield
CDISC SEND Implementation Guide
shield
FDA 21 CFR Part 11
shield
OECD GLP
shield
EU GMP Annex 11
shield
ALCOA+ Data Integrity
shield
Electronic Records & Signatures
shield
ICH Q10 Framework

Industries We Serve

Unlike generic electronic data capture systems, Zentixs Spera is designed exclusively for the preclinical research ecosystem.

Pharmaceutical Companies
Contract Research Organizations
Toxicology Laboratories
Safety Assessment Facilities
Biotechnology Companies
Research Institutes
Regulatory Submission Teams
Quality Assurance Departments

Frequently Asked Questions

It centralizes data collection, validation, review, and reporting across preclinical study phases and scientific domains.
Built-in validation checks, missing-data alerts, queries, and reviewer workflows help identify errors before reporting.
It captures animal data, dosing, clinical observations, laboratory results, toxicokinetic, pathology, and other study domains.
It transforms collected study data into SEND-compliant datasets with validation, controlled terminology, and Define-XML generation.
Yes, configurable eCRFs support dynamic fields, validation rules, calculated values, and electronic signatures.
It provides protocol-driven workflows, audit trails, electronic signatures, controlled records, and 21 CFR Part 11 support.