In today’s dynamic development landscape, a strong medical affairs partner isn’t just helpful—it’s essential. From strategic study design to real-time safety oversight, a dedicated Medical Affairs team helps ensure scientific integrity, regulatory readiness, patient-centricity, and operational efficiency across the clinical development lifecycle. The right partner brings medical insight to every decision, enabling faster, smarter progress and better outcomes.

At Premier Research, our global Medical Affairs team is made up of senior medical and scientific executives who are deeply committed to minimizing time to key development milestones while maximizing the value of your investigational products. Our team partners closely with yours, integrating deep therapeutic knowledge and functional expertise to support our cross-functional project team in making strategic decisions that meet the demands of today’s complex clinical landscape.

With more than 50 physicians across North America, Europe, and Asia Pacific, we also deliver around-the-clock medical monitoring and support services. Our regionally based experts bring not only clinical research experience, but also a practical understanding of the day-to-day challenges faced at investigative sites. This firsthand insight enables more effective site engagement, proactive risk mitigation, and improved patient recruitment strategies.

Integrated Strategy for Clinical Success

From early-stage development and strategy, to clinical trial design and execution, to regulatory submission, our Medical Affairs team supports your program with a strategic, cross-functional approach. We combine therapeutic insight with data-driven decision-making to help optimize study design, site selection, and the patient experience.

Our services include:

• Clinical Development Program Consulting
• Medical and Scientific Support for Regulatory Submission Planning and Preparation
• Protocol and Investigator Brochure Development
• Strategic Statistics Consulting
• Informed Consent Review
• Site Selection and Enrollment Enhancement
• Patient Journey Mapping and Recruitment Strategy
• 24-Hour Medical Monitoring by Board-Certified Physicians
• Medical Coding and Medical Data Review
• Data Monitoring Coordination (DMC, DSMB, Adjudication Panels)
• Access to Global Key Opinion Leaders (KOLs)
• Publication Planning and Scientific Manuscript Support
• Regulatory Agency Support
• Physician-to-Physician Engagement
• Pediatric Program Support (PREA Compliance)

Why Choose Premier?

• Strategic Alignment: Medical Affairs embedded early to drive informed planning, recruitment acceleration, and operational success
• Global Physician Network: Deep therapeutic expertise with direct site relationships across three continents
• 24/7 Safety Oversight: Continuous monitoring and immediate response to emerging safety signals
• Seamless Integration: Medical support that’s fully aligned with clinical operations and project management teams

Contact Premier today to discuss how our Medical Affairs experts can help you accelerate timelines, strengthen study integrity, and bring life-changing therapies to patients faster.