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Your Trial Pathway Partner

Our Vision
Our Vision

A close collaboration with sponsors, patients and researchers

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Our Mission

Accelerating clinical trial success with innovative solutions and uncompromised integrity—your ultimate Trial Pathway Partner!

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Our Philosophy

At SAPRO, we collaborate closely with sponsors, researchers, and patient groups to drive the future of medicine and human health with an unwavering commitment to quality.

Clinical research is a human endeavour, and the success of any trial relies on the collective experiences of everyone involved in the value chain.

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Our Why

Empowering early-stage biotech and pharma with gold standard processes and platforms for Phase I and II trials—at a fraction of the cost! Our senior teams ensure every trial is expertly planned and executed, with tailored solutions aligned to your regulatory strategy, study design, and pipeline.

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What Drives Us

SAPRO aims to revolutionise the support system for start-up and biotech companies within the clinical research industry, with a goal to redefine the traditional image associated with CROs and transform the delivery of clinical trials. SAPRO aims to become the trusted Trial Pathway Partner for these organisations, offering invaluable and flexible assistance in their journey towards success.

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Nimble Is Our Niche

Our ISO 9001:2015 validated QMS allows efficient deployment of their expertise to meet the diverse requirements of our clientele. Our experience includes running over 228 trials in 20 years across 13 countries and 24 therapeutic areas.

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Patients Are Our Priority

Prioritising the patient journey and experience in clinical trials Improves recruitment and retention around the world and ensures ethical conduct, enhances data quality, promotes regulatory compliance, and fosters trust amongst stakeholders, ultimately advancing medical research and Improving patient outcomes.

Who We Are
Who We Are

A truly experienced and committed team 

By choosing SAPRO as your Trial Pathway Partner, you are choosing access to a dedicated team focused on delivering high-quality clinical trial outcomes. Our expertise, technology, and commitment to excellence ensure precise, efficient, and integrity-driven trials from start to finish.

Our experienced Project Directors and Managers excel across various phases and therapeutic areas, including oncology.

Using tools like MS Project and our 21 CFR Part 11 compliant e-TMF (Florence), we meticulously plan every detail.

With over 15 years of experience, our Principal and Senior Clinical Research Associates (CRAs) monitor progress, ensure protocol adherence, and maintain data integrity, facilitating efficient communication and risk mitigation for successful trial execution.

Kim Steel 


Founder & Managing Director

Kim Steel, Founder & Managing Director

Kim has proven herself as a strategic, proficient, and driven leader with 18 years’+ experience in senior positions within the CRO,  Pharma and Biotech field;  she has worked across a variety of therapeutic areas with a diverse range of clients and cultures, competently directing, problem solving and managing First in Human (FIH) and Phase I-IV full service global and regional clinical drug and device studies. In recent times, she has noted a change in the clinical research industry and the application of a cookie cutter attitude by some CROs being applied to innovative and exciting studies, and clients’ being sold a solution that didn’t necessarily benefit them. As a result, Kim founded SAPRO with a mission to change how the Clinical Research Industry supports small start-up and biotech’s and ultimately change the stereotype the industry knows as a “Clinical Research Organisation” (CRO) and re-envisioned how clinical trials are delivered by allowing SAPRO to become your Trial Pathway Partner (TPP).

Quote to live by: “If nothing changes, nothing changes.”

Rhona Macdonald

Director, Clinical Innovation & Delivery

Rhona Macdonald, Director, Clinical Innovation & Delivery

Rhona is a passionate clinical research leader with over 25 years of experience across the healthcare, pharmaceutical, and clinical trial sectors. She is dedicated to driving innovation in therapies that address unmet medical needs across Australasia. Her diverse career spans pharmaceutical roles, cardiac catheterisation labs, and acute care, equipping her with a comprehensive, cross-functional perspective on the clinical development lifecycle.

With a proven track record of building and leading high-performing teams, Rhona’s leadership style fosters collaboration, consistency, and inclusivity. She excels in delivering clinical operations with precision, ensuring milestones are met through strong stakeholder relationships and cross-functional alignment.

Known for her problem-solving mindset and adaptability, Rhona champions continuous improvement and creative thinking in every aspect of clinical delivery. Her commitment to excellence and innovation supports SAPRO’s mission to deliver world-class clinical trial outcomes.

Nicole Haberman

Associate Director, Project Management

Nicole Haberman, Associate Director Project Management

Nicole is a distinguished leader in the field of clinical research, with an impressive career spanning 18 years. She has earned recognition for her significant contributions to the successful execution of numerous clinical trials, particularly in the challenging area of oncology, as well as across various other therapeutic fields. Nicole’s journey began as a Study Coordinator at renowned institutions such as Peter MacCallum and Genesis Care, where she developed her deep commitment to advancing medical research. She brings a comprehensive skill set in clinical trial management, regulatory compliance, and team leadership to her role as one of SAPRO’s Project Directors.

Throughout her career, Nicole has progressed through roles as a Clinical Research Associate (CRA) and Project Manager (PM), becoming well-regarded for her ability to adeptly navigate the complexities of the clinical research industry. Her expertise extends beyond management; she is highly skilled in developing precise protocols, negotiating complex studies, and expertly managing the intricacies of oncology, theranostics, and stem cell research. Nicole’s approach consistently challenges conventional methods, driving innovation and fostering strong collaborations with clients, cross-functional teams, and research sites.

Nicole’s unwavering dedication ensures the timely delivery of impactful outcomes for the biotech and pharmaceutical sectors, solidifying her reputation as a pivotal figure in clinical research.

Quote to live by: “Love the life you live. Live the life you love.”

Kylie Tarascio

Project Manager/Senior Clinical Research Associate

Kylie Tarascio, PM/Principal CRA

Kylie is a seasoned professional, bringing over 22 years of invaluable experience within the ANZ region to her role as a Project Manager/Principal CRA at SAPRO.
A highly skilled and dedicated individual in managing clinical trials across various sectors.  Kylie’s patient and understanding nature has meant that she has built the strongest relationships with sites and colleagues within the industry. Throughout her career, Kylie has honed her expertise within CROs, demonstrating proficiency in overseeing both device and pharmaceutical trials. Her extensive portfolio encompasses a wide spectrum of trials, from first-in-human studies to large-scale phase IV trials. Kylie has navigated the complexities of the industry with finesse, working seamlessly with companies of all sizes.. With a passion for advancing medical research and improving patient outcomes, Kylie continues to make significant contributions to the field of clinical research, embodying professionalism, leadership, and a commitment to excellence.

Quote to live by:   “It’s the simple things in life!”

Marn Ying Lum

Principal Clinical Research Associate / Quality Assurance

Marn Ying Lum, Principal CRA / QA

Marn is an accomplished professional with 20 years of experience in the clinical research industry, boasting a range of roles within small, medium, and large-sized CROs.  With a predominant background as a Principal Clinical Research Associate and a keen interest to further expand her skill set within the Quality department of SAPRO, Marn brings forth a poised and composed demeanour to every endeavour. Throughout her career, she has skilfully monitored a myriad of first-in-human and Phase I-IV global pharmaceutical drug and device trials across diverse therapeutic areas. Recognised for her serene disposition, Marn adeptly navigates challenges, leading teams with a calm yet decisive approach. She excels in fostering positive site relationships, crucial to the seamless execution of clinical studies. Marn’s positive outlook and adept problem-solving abilities make her an invaluable asset, earning commendations from both project teams and clients as a pivotal member of study initiatives.

Quote to live by: “The more grateful I am, the more beauty I see” -Mary Davis

Laine Gourley


Clinical Research Associate

Laine Gourley , Clinical Research Associate

Laine Gourley joined the SAPRO team in 2023 from the lab to ensure the clinical operations teams are fully supported. Laine has secured the confidence of her teams and Sponsors alike with her keen eye for detail, thirst for knowledge and her willingness to go the extra mile, always.  Laine is a Super User of the Florence e-TMF that SAPRO offers as a gold platform and has enjoyed her ongoing exposure to new processes, systems and company developments that being part of the Quality Assurance team has allowed her, conjoined with the travel that the unblinded monitoring role allows her to do.

Quote to live by:  “Good things happen outside your comfort zone”.

Christina Lake

Director, Pharmacovigilance

Christina Lake, Director of Pharmacovigilance

Christina has over 24 years of experience in the healthcare and biopharmaceutical industries, blending her background in nursing, marketing, and drug development. After a decade in nursing, including as a Clinical Trial Site Nurse, she transitioned to the biopharma sector in 2001. Throughout her career, Christina has worked across various settings, from biotech startups to multinational organizations, specializing in Pharmacovigilance, Medical Information, and Medical Systems. She has led teams and managed projects at local, regional, and global levels, with expertise in governance, operational efficiency, and strategic coordination.

Christina is passionate about a patient-centric, collaborative approach, focused on continuous improvement to ensure patient safety, regulatory compliance, and operational excellence. She has contributed to industry education through roles with the Australian Association of Regulatory & Clinical Scientists (ARCS), the MIMS Digital Advisory Board, and the International Society of Pharmacovigilance.

Lauren Cominos

Senior Clinical Trials Assistant

Lauren Comino, Senior CTA

Lauren brings over a decade of hands-on experience in the CRO and pharmaceutical industries, with a strong background in project support and clinical trial coordination. Known for her calm, organised, and solutions-focused approach, Lauren plays a key role in ensuring seamless trial operations across all phases of clinical development.

With deep expertise in Trial Master File (eTMF) management, audit readiness, and team coordination, Lauren supports both project teams and managers with exceptional precision and care. She is passionate about streamlining processes, mentoring colleagues, and upholding the highest standards of quality and compliance.

Whether she’s guiding team members or troubleshooting challenges under pressure, Lauren’s steady leadership and eye for detail make her a trusted and valued member of the SAPRO team.

Belinda Williams

Clinical Research Associate

Belinda Williams, Clinical Research Associate

Belinda Williams is an accomplished clinical research professional with extensive experience supporting and leading early-phase (Phase I and II) clinical trials across mental health, oncology, women’s health, gastroenterology, and healthy volunteer studies. With a strong clinical foundation as a Registered Nurse and Clinical Educator, Belinda brings a patient-centred, safety-first approach to every study she supports, underpinned by rigorous adherence to protocol and regulatory requirements.

With a background spanning sponsor and site environments, Belinda has developed particular strength in clinical quality, safety oversight, and site performance optimisation. Her practical experience in early-phase trials, combined with her leadership in quality systems and adverse event management, positions her as a trusted and capable contributor to high-performing study teams. She has led the design and implementation of organisation-wide adverse event training at the sponsor level and supported the up-skilling of research sites to ensure accurate, compliant AE reporting—initiatives that have directly strengthened data integrity and sponsor confidence.

During her tenure as a Clinical Research Associate II at Douglas Pharmaceuticals, Belinda oversaw all aspects of site monitoring across multiple early-phase trials, including site initiation, interim, and close-out visits. She also contributed to study feasibility, start-up, regulatory submissions, eTMF management, and investigational medicinal product accountability. Serving as the sole CRA during the COVID-19 pandemic, Belinda managed five New Zealand sites across two concurrent studies, maintaining a demanding six-weekly monitoring schedule. Her sites consistently performed strongly, with several ranking among the highest recruiters in the APAC region, despite enrolling highly vulnerable populations and managing a Schedule III high-risk investigational product.

Belinda holds a Bachelor of Nursing, a Postgraduate Certificate in Intensive Care Nursing, and a Postgraduate Diploma in Leadership and Management from the University of Auckland. She continues to invest in professional development across ICH-GCP, Te Reo Māori, coaching, and suicide prevention, reflecting both strong technical capability and cultural competence.

Calm under pressure and highly collaborative, Belinda is recognised for her attention to detail, commitment to patient safety, and dedication to delivering high-quality, compliant clinical trials. Her measured approach, strong clinical insight, and passion for continuous improvement make her a valued member of the SAPRO team and a trusted partner to sponsors and sites alike.

Trish Grey

Principal Clinical Research Associate

Trish Grey, Principal CRA

Trish is a highly experienced Senior Clinical Research Associate with over 25 years of involvement in the
health and research sector, spanning multiple therapeutic areas with a particular focus on cardiac and
vascular studies. Trish has built a strong reputation for dependability, precision, and deep clinical insight
across First-in-Human and complex interventional trials.

Her hands-on experience covers a broad range of pivotal studies, including randomized cardiac stent trials,
multi-centre drug-coated balloon studies for BTK lesions, and cutting-edge interventions such as intravascular lithotripsy, spur stent systems, aspiration embolectomy, and interatrial shunt safety trials.

Known for her problem-solving skills, site-level engagement, and commitment to quality, Trish consistently ensures that studies meet sponsor expectations, regulatory requirements, and the highest ethical standards. Her practical approach and unwavering reliability make her a trusted partner for sponsors and
clinical teams alike.

Helen Hennessy

Principal Clinical Research Associate

Helen Hennessy, Principal CRA

Helen is a highly experienced Clinical Research Professional with a strong background in providing clinical research services to Biotechnology, Pharmaceutical, Medical Device, and CRO clients across all clinical trial phases (I–IV). Skilled in site assessment, initiation, interim monitoring, and close-out activities, with proven expertise in Human Research Ethics Committee (HREC) submissions, site and project management, and early-phase study delivery.

Qualified Registered Nurse with additional tertiary qualifications in Health Promotion and Drug Development, combining clinical insight with regulatory and operational expertise. Demonstrates comprehensive

knowledge of ICH GCP guidelines and local regulatory requirements, ensuring quality, compliance, and efficiency in every aspect of trial conduct.

Helen is renowned for excellent planning and organisational skills, strong interpersonal communication, and the ability to build and maintain productive relationships with investigators, sponsors, and cross-functional teams. Adept at mentoring and supporting clinical research associates, managing timelines and risks, and driving high-quality outcomes within fast-paced and complex clinical environments.

Helen Knight

Operations Device Specialist

Helen Knight, Operations Device Specialist

Helen is an accomplished clinical research leader with over a decade of experience managing complex and
high-impact clinical studies across New Zealand. Helen has built a strong reputation for regulatory strategy,
and cross-functional leadership within both public and private healthcare environments. Her career encompasses extensive involvement in First-in-Human and First-in-World medical device trials,where she has consistently positioned organizations as centres of research excellence and innovation.
Helen has driven operational growth, compliance, and sustainability. Her leadership ensures that all
research programs adhere to the highest standards of ISO 14155, ICH-GCP, and applicable regulatory,
ethical, and quality frameworks.

Helen supports global sponsors, medtech companies, and research organizations in navigating the
complexities of early-phase and FIH studies. She brings deep expertise in regulatory documentation,
medical writing, and on-the-ground study management, enabling faster start-up, reduced risk, and
improved research outcomes. impactful and compliant research

*This is not an exhaustive list of SAPRO personnel.

Our Experience
Our Experience

Partner with a highly experienced and dedicated Clinical Research A-Team

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Our Footprint
Our Footprint

The perfect footprint for early and mid-phase clinical trials

Australia is an ideal location for your next Clinical Trial.

  • Streamlined regulatory process through the Therapeutic Goods Administration (TGA)
  • Well-established Ethics Committees via both public and private institutions ensures that ethical standards are met and participant safety is prioritised
    High-quality healthcare system – ensure high standards of care and data quality
  • Diverse Population – multicultural society with a wide demographic representation to enable your diversity plans
  • Government incentives: Get up to 43.5% of your R&D spend back as part of the Research & Development Tax Incentive offering
  • Research infrastructure – Australia has access to advanced research facilities and technology which supports efficient conduct of research
  • Specialised Oncology and Theranostics framework.
  • Global Recognition: Data generated from trials conducted in Australia is often recognised internationally, enhancing credibility

Despite its small site, New Zealand is recognised as a fast and cost-effective alternative for all phases of clinical trials.

  • Get up to 43% of your R&D spend in New Zealand as part of the RDTI (15%) and RDLTC (28%) programs
  • A streamlined regulatory framework, facilitating faster approval processes for clinical trials including rivalling Australia.
  • A varied demographic allows for the recruitment of diverse patient populations, enhancing the generalizability of results.
  • One of the most cost-effective locations for conducting clinical research
  • Global Recognition for data

The logical next step to be considered in your initial planning. 

  • For those clients that plan to expand their activities into the USA, SAPRO can support the Project Management and Monitoring from our HQ in ANZ, enabling a seamless expansion and continued access to the R&D rebate framework.
Our Process
Our Process

Proudly certified under ISO 9001:2015, the SAPRO QMS attests to our dedication and our commitment to excellence in service delivery, meeting customer expectations and regulatory standards while focusing on continuous improvement.

ISO 9001:2015

What We Do
What We Do

Tailored consulting services or a full-service CRO we have you covered!

General Consulting Services

SAPRO offers comprehensive guidance and oversight of the clinical research pipeline, program development encompassing pre-clinical programs, KOL access, CRO selection, bid defence attendance, GAP Analysis and start-up feasibility to ensure you get off to the best start with a team that you choose. We understand transparency is key with a board or with ongoing investors, we help you make the best decisions and plan for your success.

Elite Project Management and Direction

Leading on from our consulting services, our expert management team will manage and oversee all aspects of your clinical trial start up through study output delivery to world standards.  Our extensive knowledge, experience and networks that have matured over the years means you have  top-tier support where and when you need it.   We adhere to ICH GCP, ISO 14155, and relevant local guidelines, ensuring compliance and excellence at every step. Partner with us to optimise your clinical trials and achieve successful outcomes.

Clinical Trial Start-Up, Monitoring and Close-out

Our Clinical Research Associates (CRAs) are highly experienced professionals who have established strong networks and relationships with clinical trial sites. This ensures the reliability of data integrity and timely delivery of results for your trial. A well-managed start-up phase is crucial for the success of any clinical trial, as it sets the foundation for the entire study. At SAPRO, our CRAs excel in getting everything right from the outset, laying the groundwork for a smooth and efficient research process.

Pharmacovigilance and Medical Monitoring

SAPRO leverages a network of experinced and practicing physicians to oversee all medical aspects of your clinical trial, prioritising participant safety and data integrity. Our team facilitates essential safety review meetings to safeguard participant well-being while maintaining the scientific validity of the study.
Additionally, we offer a FDA-validated safety database solution – SafeSphere.

Regulatory and Medical Writing

Meet our experts and Key Opinion Leaders specialising in the design and recommendation of study protocols for Phase I and II trials. Well-defined protocols, targeted Investigator Brochures, and concise Clinical Study Reports are essential for the success of your trials and your ongoing pipeline.
Our teams are also available to tailor your Oncology clinical study, ensuring it remains competitive with current literature. Inquire about Adaptive Platform Protocols, which can significantly reduce your start-up time and costs, helping you bring your product to market faster!

Vendor Management

At SAPRO, we specialise in managing the intricate web of responsibilities and outputs needed at various timepoints by all vendors. Our dedicated team will take the reins, expertly coordinating all vendors to ensure seamless communication and absolute collaboration. We leverage our extensive networks and experience to streamline processes, reduce delays, and minimize risks. With our oversight, you can focus on what matters most: the success of your trial.

Biometrics

Your data results represent the culmination of all efforts and expertise throughout a clinical trial, and their importance cannot be overstated. Collaborate with our senior Data Managers and Biostatisticians to ensure your study is appropriately powered, maintaining high data integrity for producing quality TFLs that meet Australian, FDA, and EMA requirements.
By planning effectively from the outset, you can avoid the costs associated with double programming. Your Project Manager will guide you through the process.

Testimonials
Testimonials

Delivering the highest standards of quality and reliability

Tom Okarma, Executive Chairman, Regencor

“An extremely well managed CRO. We are thrilled with all aspects of the service provided by SAPRO, rapid response times to new queries, issues, expectations are exceeded and executed beautifully and accurate in detail.”

Tom Rau, CEO & Alyce Mayfosh, CSO of Wintermute Biomedical

“We are immensely grateful for the outstanding support provided by the SAPRO team throughout our Phase Ib clinical trial at Wintermute Biomedical. Kim’s exceptional communication and meticulous budgeting ensured a seamless workflow, culminating in the timely approval and budget adherence for our project. Through their efforts, we successfully received HREC approval, aligning with our timeline and setting the stage for the trial launch. SAPRO Consulting’s expertise, unwavering support, and nimble problem-solving have been instrumental, and we wholeheartedly endorse them as a premier Clinical Research Organization”. (Dec 2023)

Brent MacGregor, CEO, Medical Developments International

“We retained SAPRO to work with us on two different development projects that had become problematic with no positive end in sight. Kim and the team set about bringing order to our arguments with our respective counterparts, delving into the clinical details in tremendous depth and advocating paths forward that could generate a positive result for all parties. In a remarkably short amount of time, her grasp of the clinical issues at play led to outcomes that were beneficial to our company. These successes could not have occurred without SAPRO’s work. You deserve much credit for this outcome which has allowed Penthrox to be used in children from 6 years+. I will not soon forget the efforts you drove with the original CRO particularly considering the challenges experienced.

Linda May-Zhang, CSO, Blue California

“SAPRO was accommodating to all of our requests and kept our project going despite internal challenges, highly recommended for local sponsorship, remote monitoring and robust site management.”

Sue Anne Yee, Associate Director, MDI

“Instrumental in assisting us rescue and close our study, facilitating a robust analysis and CSR that will be pivotal in the management of pain across the UK and Ireland.”

Contact Us
Contact Us

If you have any questions or would like to book in a time to further discuss our services or vendors, please contact us via email or phone, or send us a message using the contact form below or reach us through LinkedIn.

[email protected]
+61 (0)410 103 781
LinkedIn

    SAPRO INTERNATIONAL™
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