Secure Full Oversight and Data Integrity

Under the OECD Principles of Good Laboratory Practice (GLP), the study sponsor remains ultimately responsible for the integrity of final reports, even when testing is contracted to a third-party CRO. To mitigate the risk of technical failures or regulatory rejections, the OECD permits sponsors to appoint a study monitor to oversee the study’s design and implementation. SAXOCON acts as your expert intermediary, ensuring that every study is scientifically sound and fully compliant.

SAXOCON provides the end-to-end oversight required to manage your external testing programs, including:

• Strategic Study Development:
  Designing a comprehensive testing strategy tailored to specific regulatory frameworks, such as FDA, EMA, or EFSA.
• CRO Selection:
  Identifying and vetting Contract Research Organizations with the specific capabilities to deliver high-quality, relevant data.
• Active Monitoring:
  Acting on your behalf to develop study plans, oversee progress, and ensure strict adherence to protocols.
• Technical Review:
  Critically assessing study conclusions, toxicological data, and the scientific rationales for data inclusion or exclusion.

Why Choose SAXOCON?

Our study monitoring services provide the expert vigilance needed to protect your investment:

• Extensive Regulatory Knowledge:
  Best-in-class understanding of the complex international standards governing GLP and safety testing.
• In-House Toxicological Expertise:
  Direct access to a multidisciplinary team that can interpret raw data and challenge CRO findings when necessary.
• Strategic Relevance:
  Smart, cost-effective strategies that ensure your testing is designed correctly the first time, avoiding the high cost of repeat studies.
• Unbiased Advocacy:
  We act exclusively in your interest, serving as a technical bridge between your organization and the laboratory.

Delivery

SAXOCON reviews and compiles all necessary documentation, providing an expert interpretation of the study results. Our deliverables ensure that your final reports are robust, defensible, and ready for submission to global regulatory authorities.