Access to the U.S. Market

Strategy, Expertise, Trial Design and Full-Service Management to Bring Your Oncology Drug to the U.S. Market

For sponsors with little to no U.S. presence, designing and managing clinical trials for oncology drugs in the U.S. is an arduous task. It’s difficult to be effective from afar, without the deep first-hand knowledge required to navigate the FDA, design the right protocol, select the best investigators, accrue patients, and analyze the data.

Medelis will design the plan for bringing a non-U.S.-based company’s drug into the clinic. This short-term consulting engagement can have a dramatic impact on your pathway to the U.S. market – giving you the assurance of a team of oncology experts, who have a comprehensive understanding of the nuances of the U.S. market, to guide your drug development plan.

Value to Sponsors

Having our team of oncology drug development experts guiding your U.S. development plan gives you:

• A detailed understanding of the U.S. market and regulatory environment
• The best solutions for a study design that works for your product or treatment
• Recommendations for the most effective investigators and the right mix of sites (of all sizes) for your trial
• Solid relationships with key thought leaders and patient advocacy groups needed to support your study design
• A full-service CRO to handle all aspects of the trial (if desired).