When developing a new drug, it is critical to start off on the right path to avoid wasting large amounts of capital trying to correct the problem in later stages. At Ashuren Health Sciences, the scientists and regulatory affairs specialists can provide expert clinical advice at the early stages of drug development to save you time and money.

Ashuren Health Sciences can:

• Design and prepare of Phase I and Phase I/II first-in-human clinical trial protocols and coordinate 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);
• Provide advice on how nonclinical safety findings impact the human starting dose and protocol design;
• Position nonclinical safety and findings to clinicians;
• Prepare and/or review of the Investigator’s Brochure;
• Liaise with regulatory authorities;
• Facilitating meetings and provide independent, third-party advice on, and responses to, any scientific and regulatory issues;
• Provide strategic advice on regulatory agency issue resolution;
• Coordinate the clinical development team, including interactions between toxicologists and clinicians;
• Advise, plan, coordinate, and monitor work with contract organizations in order to ensure consistency with protocols and compliance with GCP standards.

Our global perspective, efficiency and scientific expertise, will ensure that you begin the journey for long-term success.