Your Trial Pathway Partner

Our Vision

A close collaboration with sponsors, patients and researchers

Our Mission

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

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.

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.

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.

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.

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

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 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.”

Charles Beasley 

Strategic Partnerships Director

With over a decade of experience in the clinical research and pharmaceutical industry, Charles has held a diverse array of roles across Regulatory Affairs, Clinical Operations, Medical Writing, and Project Management.

Having worked on numerous global studies, Charles has had extensive exposure to regulatory agencies such as the FDA, EMA, and TGA, and has navigated the real-world challenges of clinical trials in multiple jurisdictions and managing multiple stakeholders. Charles excels in fast-paced environments and enjoys collaborating closely with teams and sponsors, contributing to trial strategy, and ensuring that key deliverables are met.

With a strong interest in rare diseases, CAR-T, and theranostics, Charles joined SAPRO driven by a shared vision to redefine how niche biotech companies are supported in the industry. He is dedicated to promoting the growth of clinical research in his native New Zealand, highlighting the region’s untapped expertise, and enabling SAPRO to deliver studies more efficiently for clients.

In his spare time, Charles hosts the podcast and YouTube channel “GoodClinical,” where he showcases the latest developments in medicine and human health across New Zealand, Australia, and the USA.

Quote to live by: “Flexibility in your approach is just as important as the discipline in your execution.”

Nicole Haberman

Project Director

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 is a seasoned professional, bringing over 22 years of invaluable experience within the ANZ region to her role as a Project Manager/Senior Clinical Research Associate 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 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 Trials Associate

Laine Gourley joined the SAPRO team from the lab to ensure the clinical operations teams are fully supported. Relatively new to clinical trials, 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

Pharmacovigilance Director

Christina has over 20 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.

*This is not an exhaustive list of SAPRO personnel.

Our Experience

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

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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

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

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.
We also offer dedicated pathways and solutions for Oncology, Hematology, and Theranostics. Additionally, we offer a FDA-validated safety database solution.

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

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 and we definitely look for”

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

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