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.
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.
Supported SEND
Domains
Study Phases
Covered
Part 11
Compliant
Protocol-Driven
Forms
Collect standardized data from every study phase, treatment group, and scientific domain while maintaining complete traceability and regulatory compliance.
Automatically generate data collection forms based on study protocol, design, animal groups, dose levels, and study schedule. No manual form creation required.
Capture observations according to each study phase with configurable forms, validations, and approval workflows.
Collect structured data across all scientific domains following standardized templates with configurable fields.
Improve data quality using built-in validation including range checks, duplicate detection, outlier identification, and cross-domain validation.
Monitor data collection activities across every study with a live dashboard showing completion rates, pending forms, review status, and locked records.
Design eCRFs without programming. Supports dynamic forms, conditional fields, validation rules, calculated fields, and electronic signatures.
Comprehensive coverage across all preclinical study components — from acclimatization through histopathology and regulatory submission.
Automatically transform collected study data into SEND-compliant datasets for regulatory submission — validated and ready for FDA review.
Empowering diverse industries with tailored digital solutions, scalable technology, and results-driven innovation.
Generate comprehensive reports at every level — from individual animal observations to complete regulatory submission packages, all in inspection-ready formats.
Unlike generic electronic data capture systems, Zentixs Spera is designed exclusively for the preclinical research ecosystem.