Bioanalysis Software

The Sapio Bioanalytical LIMS and ELN is a comprehensive platform designed to manage bioanalytical studies with flexibility and reproducibility. It supports both small and large molecule workflows, as well as multi-modal processes in clinical and non-clinical settings. The platform ensures complete traceability and control from the initiation to the closeout of studies, featuring built-in data validation, study design, and information management capabilities.

Bioanalysis involves the quantitative measurement and analysis of drugs, metabolites, and biomolecules within biological systems. This process is crucial for understanding the absorption, distribution, metabolism, and excretion (ADME) of compounds, supporting pharmacokinetic, pharmacodynamic, and toxicological studies.

Key Features

• Master Assay Creation and Quality Control: Create master assays to maintain quality across analytes, utilizing built-in curve fitting and statistics for validation and quality control.
• Configurable Workflow: Tailor protocols and methods to suit different experiments and research objectives, allowing for quick modifications and hypothesis testing.
• Traceability End to End: Manage sample registration, approval, receipt, and storage with a robust tracking system, ensuring compliance and visibility throughout the workflow.
• Seamless Instrument Integration: Integrate with lab systems through APIs and webhooks for real-time communication and workflow orchestration.
• Compliance Built-In: Adheres to GLP, GCP, GMP, and other regulatory standards, ensuring data integrity and compliance with FDA and EMA guidelines.

The platform also offers pre-built bioanalytical templates, instrument and materials management, method development, and sample preparation tools. It supports method validation and execution, interactive 3D plater, reusable assays, and science-aware data analysis and visualization.

Sapio Bioanalysis streamlines the bioanalytical process with ready-made workflows and experiment templates, supporting detailed tracking of dosing, sample, and measurement scheduling. It enhances method validation and data analysis through integrated analytics, ensuring high standards of accuracy and reproducibility essential for regulatory submissions and scientific research.