Early Phase Clinical Trials
As a full-service contract research organization, 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, 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
What our clients say
“Your CRAS are top notch and I would work with Southern Star Research any opportunity I could get! Thank you. I know this program was a head banging experience for the team, and they handled it all beautifully.”
Project Director, Clinical Operations, US CRO (Oncology)
“As you know we have wrapped up the project, and I wanted to let you know that our internal PM, had really great things to say about your team at the wrap up of the study, especially your PM. Thank you for your commitment to the project and your help with the client over the years.”
Vice President, US based CRO (Pancreatic Cancer)
“I just wanted to touch base to sing praises about your wonderful CRA, now we have handed over responsibilities for the trial. They are such a pleasure to work with! We are really going to miss having them on our team. He has the most lovely manner of working and is flexible, positive, organised and we have loved having him on board with us”
Global Clinical Trials Manager, Australian Pharmaceuticals (Urology)
“Thank you all for doing a lot of preparatory works during SSU period, let us keep up our good work and effective communication so as to let a high-quality study delivered. Thanks again!”
Clinical Operations Manager, Chinese Biotech (Healthy Volunteer)
“I just wanted to say Thank you for a fantastic job you do with our SAEs and staying on top of everything. It is a real pleasure to work with you and I appreciate all you do to support our study.You do a fantastic job!!”
Head, Clinical Operations, US Biotech (Epilepsy)