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Pre-clinical and Clinical Trial Management

We help manage pre-clinical studies to validate safety and effectiveness before human trials. We also assist with clinical trial applications (CTA) for each Phase, ensuring proper documentation.

Manage Pre-clinical Studies

We manage pre-clinical studies, ensuring that your product undergoes rigorous testing in the laboratory and animal models before human trials. Our team conducts process characterization and refines production methods to ensure consistency. Additionally, we oversee PPQ batch validation, confirming that manufacturing processes produce reliable results.
Scientists grow mini human livers from stem cells, successfully transplant them in rats

Manage Clinical Trial and Support Product's Approval

For clinical trials, we assist in CTA Phase 1, where initial human testing evaluates pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity. In CTA Phase 2, we help design studies to assess dose ranging and safety, determining the optimal therapeutic levels in a small group of people. Moving to CTA Phase 3, we manage large-scale trials to confirm safety and efficacy in diverse patient populations. Our expertise in clinical development ensures regulatory compliance, efficient trial management, and data collection to support product approval.
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Let Us Support Your Product's Success

SartoMax is committed to accelerating the future of biopharmaceutical development. Contact us to explore more how our CDMO solutions can support your biomanufacturing goals.
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Frequently Asked Questions

Pre-clinical studies evaluate your product’s safety, bioactivity, and pharmacological profile using lab and animal models. These studies are critical to gaining regulatory clearance for human clinical trials.
Process characterization involves analyzing and refining the manufacturing process to ensure consistent and reproducible results, laying the groundwork for regulatory approval and clinical reliability.
We manage PPQ batch validation, a regulatory requirement before advancing into clinical or commercial production, to confirm that your manufacturing process produces consistent and compliant batches.

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