EARLY PHASE SPECIALISTS

Southern Star Research’s early phase specialist team addresses and supports the needs of pharmaceutical, biotech and medical device companies in the early states of clinical development. Drawing on a huge volume of experience built up over many years working in Australia’s clinical research industry, the team can assist with all aspects of your study including the crucial early stages of study planning.

Here we can support with:

  • Initial Study Concept and Design
  • Scientific Review
  • Pre-Clinical Data Package Assessment
  • Endpoint Development
  • Statistical Sample Size Calculation
  • Protocol Writing to ICH-GCP
  • Phase 1 unit / Site Selection

PHASE 1 THERAPEUTIC AREA EXPERIENCE

Cardiovascular
Dermatology
Gastroenterology
Infectious Disease
Medical Devices
Oncology

Depending on the project, Southern Star Research’s collaborative Early Phase Development Team may include our Managing Director, Chief Scientific Officer, Medical Monitor and Chief Biostatistician. We work with our clients to support them in strategically planning for the molecule or device development rather than focusing solely on the operational aspects of the study at hand. This enables our clients to plan their product development programs effectively and efficiently.

Southern Star Research has established relationships with the Phase 1 Units located in all of the major cities in Australia. Southern Star Research will be able to connect you with the appropriate specialist investigators or representative groups to support your study.