Study Sponsor Monitor
The OECD series on the Principles of Good Laboratory Practice and Compliance Monitoring guideline, number 11, enumerates the roles and responsibilities of the study sponsor relating to GLP. It recommends that when sponsors contract with a CRO to conduct a study, the sponsor is ultimately responsible for the integrity of the final reports. The OECD allows sponsors to hire a study monitor to act as an intermediary and control the design and implementation of a study.
SAXOCON provides you with everything you need to develop an end-to-end study strategy, including:
- Develop a study strategy for a product that covers, for example, EFSA and/or the FDA
- Find a CRO with the capabilities to conduct a high-quality, relevant study
- Act on your behalf to develop a study plan and monitor the study’s progress
- Review the study conclusions and assess the safety data and toxicological testing, including the rationales for including or excluding specific data.
Why choose us?
SAXOCON services for the study monitoring give you access to:
- Extensive, best-in-class understanding and experience with the complex landscape of international standards and regulatory guidelines
- A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
- Toxicological evaluations by our in-house experts
- Smart, cost-effective strategies that ensure your testing is well-designed and relevant
Delivery
SAXOCON reviews and compiles the necessary documentation interpreting the study results.