Navigate The Early Phases Of Product Development With Ease

With a broad range of experience delivering Phase 1 Healthy Volunteer, First in Human, First in Patient and Phase 2 trials, we know just how important it is for your asset to succeed in the early development lifecycle. Our experienced team will help you obtain high-quality data that will appeal to future investors, meet the requirements of international regulatory bodies such as the FDA, EMA, PMDA, and Health Canada, and prepare your product for larger Phase 3 and 4 studies, partnerships, licensing, and sale.

Whatever your clinical trial needs, we can provide a flexible, bespoke solution that will not only meet your regulatory requirements but also position your product for commercial success.

Support

We can support you with any / all of the following areas:

• Initial study concept and design
• Scientific review
• Pre-clinical data package assessment
• Clinical trial protocol writing to ICH-GCP standards
• Endpoint development
• Statistical sample size calculation
• Phase 1 unit / site selection
• Clinical trial data services and biostatistics

Our Phase 1 Experience

• Pharmacokinetic (PK) and pharmacodynamic (PD)
• First In Human (FIH)
• Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)
• Food effect (FE)
• Drug-drug interactions (DDI)
• Healthy Volunteer and Patient cohorts
• Anti-infective challenge trials
• Oncology
• Longstanding, ongoing relationships with all Phase 1 units

Why choose Southern Star Research?

• Full-service, early-phase specialists
• Flexible, bespoke clinical trial solutions to meet your unique needs
• Accurate, detailed pricing, without any surprises
• Proactive team of experts ready to drive your study forward
• Unparalleled experience across a range of areas and trial phases
• Nimble, responsive, and streamlined approach
• Customer-focused, honest, and open relationships
• Dependable data, results, and insights