We have the team and expertise to improve the quality and integrity of your study data.
Reach your key milestones faster
Our Medical Affairs experts focus on minimizing the time to key milestones and maximizing the value of your investigational products. These physicians, based in the United States, Europe, and Asia, provide 24-hour medical monitoring services and support for project management teams and sponsors.
They have broad expertise in neuroscience, analgesia, dermatology, hemato-oncology, medical device, pediatrics, and rare diseases and understand the key clinical challenges in the countries where we conduct clinical trials. They’re fluent in local languages, medical practices, and cultures, enabling them to communicate effectively with site staff.
Our medical experts engage with sponsors early, before they enter human trials, working closely with our biostatistics, operations, and medical writing teams to minimize the time to key milestones while maximizing the overall value of product development.
Developing an orphan drug? Our success in pursuing novel applications has led to immediate increases in valuation for biotech firms, creating leverage for additional fundraising. We keep ahead of the technology curve – for example, Premier Research began electronically submitting IND applications long before the FDA started mandating e-submissions in 2018.
PREMIER INSIGHT 268
We said yes
The client asked the nearly impossible – a task so daunting that two other CROs had simply said “no, thanks.” Completing a new drug application typically takes a year to a year and a half, but the time available here was six months. And the short timeline was only the half of it.
FDA’s updated guidance
In 2019, the U.S. Food and Drug Administration updated its draft guidelines for drug discovery in rare diseases. The changes can help sponsors perform more efficient development programs and gain new insights on the development process.