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Early Phase
Specialist CRO

request a proposal

As a full-service clinical research organisation, Southern Star Research has the knowledge, industry relationships and technical expertise to get your early phase clinical trial up and running safely and efficiently.

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 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. 

Our team's collective experience:

0%
projects in Phase 1 or Phase 2
0 +
Phase 1 studies
0 +
Phase 2 studies

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 and ISO standards
  • Endpoint development
  • Statistical sample size calculation
  • Phase 1 unit / site selection
  • Clinical trial data services and biostatistics
CRO Early Phase Specialist
CRO Early Phase Specialist
Our Phase 1 clinical trial therapeutic experience includes:
  • Pharmacokinetic (PK) and pharmacodynamic (PD)
  • First In Human (FIH)
  • Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)
  • Broad Phase I therapeutic experience, including:
  • Cardiovascular
  • Dermatology
  • Gastroenterology
  • Infectious Disease
  • Endocrinology
  • Neurology
  • Oncology
  • Respiratory
  • Orthopedics
  • Urology
  • Women’s and Men’s Health
  • Ophthalmology
  • Medical Devices
  • Radiopharmaceutical

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
CRO Early Phase Specialist

Request a proposal

“What a stellar job you’re doing with the SAD study – so calm, confident and professional. In my 30+ years training and managing project managers you stand out by far as one of the best I have seen. I am proud to have you as part of our team.”

Phase 1 study, local Biotech company

“Thank you, your professional attitude and constant support are much appreciated.”

CEO, Australian Medical Device Company

“Their expertise is second to none, they are on the ground working with sites intimitely with close attention to detail to ensure that the job gets done. With Southern Star you dont feel like you’re dealing with big organisation – you get a face to face personal approach.”

Director of Regulatory Affairs

“SSR take time to find out how we work and are solutions focused suggesting things that might help our business. They invest in great outcomes and are willing to think about the long term relationship and how they might work better with their partners.”

Head of Trial Management & Monitoring

“Working with Southern Star Research gives us a level of security, you know your trial will be delivered as expected without surprises. Communication is easy and they are flexible, we talk through issues and adapt continuously to fine tune and tailor to what we need.”

Clinical Trials Program Manager

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Copyright 2023 Southern Star Research Pty Ltd
1 Merriwa Street, Gordon, NSW, 2072 Australia

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