Medical Affairs

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 PERSPECTIVE

Real-world data and real-world evidence

We at Premier Research are meeting the challenge of developing alternative paradigms and new ways to solve old problems. One such opportunity that has emerged concerns the use of real-world data (RWD) and real-world evidence (RWE).

Data quality in decentralized clinical trials

Pandemic-related disruptions have accelerated much-needed change in clinical operations, but this change has been accompanied by questions about data collection and data quality. These trials may require different approaches for collecting and managing data and complying with evolving regulatory guidance.

Related Services

Medical affairs is part of a wide range of service offerings that include biostatistics, regulatory consulting, and pharmacovigilance. Follow the links below to learn more about how clients gain from our specialized expertise.