Clinical Trials & Presentations

When developing a new product, it is critical to start off on the right path, rather than wasting large amounts of capital trying to correct the problem at later stages. The scientists and regulatory affairs specialists of NutriSciences provide clinical advice at the early stages of product development based on the unparalleled expertise in toxicology and regulatory issues (design specific to health claim).

Having successfully worked with numerous companies, of varying sizes, on their drug development, NutriSciences can provide the services listed below.

• Design and preparation of Phase I and Phase I/II first-in-human clinical trial protocols and coordination of input from consulting medical specialists.
• Review of clinical trial protocols to assess whether the design (endpoints, safety parameters) is adequate/appropriate for the objective(s) of the trial and taking into consideration the existing supporting toxicology and safety data.
• Provide advice on how preclinical safety findings impact the human starting dose and protocol design.
• Preparation and/or review of the Investigator's study based on knowledge of both the available toxicology and human safety data.
• Liaising with regulatory authorities, including facilitating meetings and providing independent, third-party advice on, and responses to, any scientific and regulatory issues.
• Coordination of clinical development team, including interactions between toxicologists and clinicians.
• Advising, planning, coordinating, and monitoring work with contract organizations in order to ensure consistency with protocols and compliance with GCP standards.

By coming to NutriSciences in the early stages of product development, our global perspective, efficiency and scientific expertise, will ensure that you begin the journey for long-term success.

Click here for our "Clinical Trials & Presentations" portfolio.