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Clinical Trial Data Management & Biometrics

Position your product for success with deeper, more rigorous insights.

Biometrics

Empower Your Study With Our Biometrics Expertise

Biometrics is vitally important to the success of your study. Our intelligent, data-driven team provides accurate and transparent insight to your results, making the most complicated aspect of clinical trial manageable and cost-effective.

At Southern Star Research, our data managers, biostatisticians and programmers have the experience and discipline needed to ensure that we can offer you the highest quality biometric services that lead to deeper, more rigorous insights.

Data Management Solutions For Clinical Trials

Data management is one of the largest cost drivers in clinical trials, which is why we work hard to ensure your Electronic Data Capture system (EDC) and Case Report Forms (eCRFs) are accurate from the beginning. 

Our team specializes in designing high-quality, efficient and intuitive databases that streamline your clinical research data in an easy-to-understand format. The systems we use are highly adaptable and scalable, allowing us to flex our offering to meet the unique needs of your study. 

Unlike many other CROs, we cost everything upfront, so there are no unexpected charges related to data management at later stages in your trial.

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Biometrics

Our Clinical Trial Data Services Include

The services provided by our highly experienced Data Managers include:

  • EDC/eCRF database design and build to CDASH standards
  • Expertise in leading eCRF systems (Zelta and Viedoc)
  • Thorough cleaning and validation of your clinical trial data
  • Medical coding of adverse events and medications
  • Importing and reconciling of external laboratory data
  • Providing metrics to keep you up to date with study progress
  • Achieve your timelines for go-live and database lock.

Cutting-Edge Biostatistics Services: Driving Clinical Trial Excellence

Our team of in-house statisticians provide assistance in all aspects of biostatistics, from study design and statistical input to protocols, programming of statistical outputs and input to the final report. With one of the most experienced teams in the industry, we have a depth of knowledge and expertise that is unparalleled within the industry, meaning you can rest assured that your trial’s data will be both accurate and beneficial to the future success of your product.

Our biostatistic services include:

  • Input into protocol design
  • Sample size calculations
  • Randomisation schedule development
  • Statistical analysis plan development
  • Programming of tables, listings and figures
  • Statistical analysis (interim and final)
  • Publishing of statistical reports
  • General statistical advice on efficacy and patient safety
biometrics research

What our clients say

“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)

“I would also like to thank you and your colleagues very much for your dedicated and thorough work on this issue and that I am appreciating very much to work with all of you on the other side of the earth i.e.: Down Under!;-) !”

Vice President, Head of Clinical Pharmacology

Swiss Pharmaceutical company (Diabetes)

“On behalf of the Clinical Team I would like to thank-you for your wonderful assistance with our ethics application and also soon to be submitted, our SSA forms. Your assistance has really helped our team and enabled us to keep on track to submit according to our internal deadlines. Thank-you for all your advice, reviews and creation of documents.We look forward to working with you again.”

Clinical Development Medical Physicist

Australian Biotech (Oncology)

“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)

Contact us

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Head Office:

L1, 1 Merriwa Street,

Gordon, NSW, 2072 Australia

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Specialist experience

Each member of our Leadership Team boasts an average of 30 years experience. Our clients have access to an extraordinary group of Clinical Research professionals, whose experience covers Multinational Pharmaceutical companies, Biotechnology, Medical Device, CRO’s, research institutes, Universities, Industry Associations & Government Bodies. Together, we ensure that every aspect of your unique and novel drug study  clinical trial is handled with scientific precision, care, and foresight.

Our team has all of the tools, knowledge and experience to solve almost any issue that may arise during the complex clinical trial process.

We recognize that each study is unique and different and there are nuances that need to be resolved proactively.

Our advisory board of top-tier specialists in multiple therapeutic areas engage in the early stages from protocol design in constructive discussions to anticipate challenges and enhance study efficiency throughout the study.