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Clinical Operations

From study feasibility and recruitment to trial monitoring and quality assurance.

Clinical operations

Our Approach

At Southern Star Research, we have extensive experience across all aspects of clinical operations and a wide range of therapeutic areas. We specialize in providing flexible, high-quality, and custom solutions that help you deliver regulator-ready data on time and at a predictable price.

As a large proportion of our clients are geographically dispersed, we understand how important it is to be able to trust that your CRO is working in your best interests. That’s why we pride ourselves on building strong, transparent, and close relationships with our clients.

Our team of experts will guide you through the clinical trial process using a proactive and collaborative approach, ensuring that your stakeholders are always informed, in control, and confident throughout the journey. 

Site Management and Monitoring

Our site management and monitoring team, within the clinical operations department, consists of expert Clinical Research Associates (CRAs) with a broad range of experience across different therapeutic areas, phases, and intervention types. A highly skilled CRA plays a crucial role in ensuring the success of a clinical trial by:
  • Monitoring compliance with regulations and protocols
  • Identifying and managing safety issues
  • Maintaining data quality and integrity
  • Identifying and mitigating risks
  • Ensuring investigator and site compliance
  • Facilitating site communication and collaboration

Developing and maintaining strong relationships with sites comes naturally to our CRAs. A respectful and trusting relationship enables all aspects of site management and monitoring to be conducted efficiently. Working closely with sites (and other vendors) assists with timely recruitment whether that be healthy volunteers or the more complicated type of participants.

We have Clinical Operations Staff throughout Asia Pacific including Australia, New Zealand, Philippines, Malaysia, Singapore, South Korea.

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Clinical operations

Accelerating Clinical Trial Site Activation

We are deeply committed to activating your trial sites as quickly as possible. We understand the importance of time in the clinical trial process and strive to incorporate efficiencies and economies of scale at every opportunity without compromising quality. Our dedicated site liaison team will handle all aspects of site start-up, including site identification, site feasibility, ethics, regulatory, budget, and contract negotiations. With our streamlined study start-up process, we can help you achieve accelerated timelines, reduction in costs, and deliver new treatments to patients sooner.

Study Feasibility

We conduct in-depth site feasibility assessments, identifying the right sites with the right participants to meet your project’s specific needs.

Leveraging our well-established and extensive network of engaged investigators and key study sites ensures timely, comprehensive, and accurate responses, including:

  • Health condition incidence/Disease states
  • Treatment patterns
  • Protocol design
  • Participant recruitment rates
  • Competing studies
  • Site resource and facilities
With over 50 years of combined industry experience, our site liaison team goes above and beyond to identify sites that deliver both quantity and quality.
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Biometrics

Site Relationships

Our site liaison team invests the time needed to build and maintain site relationships, through mutual trust and respect. We promote open and timely communication to foster collaboration with investigators and study site teams.

Project Management

Our team of Project Managers are among the most experienced in the Asia-Pacific region. With a focus on building proactive relationships with our clients, sites, and investigators, you can rely on them to drive your study forward and strive to deliver reliable data rapidly, and within budget.

Clinical operations

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.