In the high-stakes world of drug development, data is more than numbers—it’s the foundation for regulatory approvals, clinical trial design, and patient safety. For sponsors navigating preclinical development, data integrity is not just a regulatory checkbox—it’s a strategic imperative.
At InfinixBio, we partner with biotech and pharmaceutical clients to ensure that every data point generated in preclinical studies is accurate, reliable, and audit-ready. Here’s how sponsors can uphold the highest standards of data integrity from the very beginning.
Data integrity refers to the accuracy, completeness, and consistency of data throughout its lifecycle. The concept is often summarized by the ALCOA+ principles:
For preclinical studies, this means every observation—whether from a toxicology report, pharmacokinetic assay, or bioanalytical readout—must be traceable, reproducible, and protected from tampering or loss.
Data generated during preclinical development supports critical decisions, including:
Compromised data can lead to study repetition, regulatory rejection, or worse—patient risk. Regulatory authorities such as the FDA, EMA, and OECD expect sponsors to demonstrate that their data is trustworthy and their systems are compliant with Good Laboratory Practice (GLP) guidelines.
Start with the right partner. Ensure your CRO operates under a validated Quality Management System (QMS) and is routinely audited for GLP compliance.
At InfinixBio, our facilities and workflows are designed to meet the strictest regulatory standards.
All data should be recorded in real-time, be clearly attributed, and be stored in validated systems.
This includes lab notebooks, electronic data capture systems, and audit trails. Avoid transcription errors with direct data input when possible.
Every person involved in study conduct must understand their role in protecting data integrity.
This includes training in SOPs, GLP expectations, and handling deviations or anomalies.
Build internal checks into the study lifecycle. Quality Assurance (QA) personnel should conduct audits of critical phases, including protocol adherence, data entry, sample handling, and reporting.
Whether performing a toxicokinetic analysis or a stability assay, all equipment and software must be calibrated, validated, and documented.
This ensures the reproducibility and reliability of results.
We understand that our clients depend on defensible, high-quality data to advance to the clinic. Our approach includes:
Whether supporting IND-enabling toxicology or bioanalytical method validation, we treat data integrity as a core value.
In drug development, data drives decisions—and trust drives partnerships. Sponsors that prioritize data integrity not only satisfy regulators but also build a foundation for efficient development and long-term success.
Ready to strengthen your preclinical data strategy? Contact InfinixBio to learn how our quality-first approach can help safeguard your program’s integrity from the start.
Our experienced lab team is here to help. Reach out today to learn more.
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