B24. Decentralized Clinical Trials (DCT) – welcome to the DCT steamboat, select your favourite ingredients!

Tracks
Data, Technology and Informatics
Wednesday, June 4, 2025
4:30 PM - 5:30 PM
Parkside 2

Chair & Speakers

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Dr Jon Carrano
Managing Director
Pharmsite

B24: Decentralized Clinical Trials (DCT) – welcome to the DCT steamboat, select your favourite ingredients!

Abstract

Post-COVID, the conduct of DCT’s (Decentralised Clinical Trials) has been boosted by recent regulatory guidance from FDA and other jurisdictions. This has spurred further harmonisation and innovation and provides an opportunity for Australia and our Asian neighbours to capitalise on participation in global trials. Convergence in Digital Health Technologies (DHTs), including telehealth, data-interchange standards, and generative AI, as well as innovations in wearables and in-home medical devices - all underpinned by connectivity and secure cloud platforms - present an abundance of alternatives. Given this smorgasbord of offerings, teams are challenged to navigate this diverse menu to find the right mix of DCT ingredients to ensure optimal trial conduct and patient outcomes. While the objectives are clear for the various stakeholders, the flexibility and terminology can be confusing. For patients, the aim is efficient recruitment across a wider range of trials, operational efficiencies, and optimal clinical outcomes. For sites, it's about increasing trial capacity and streamlining processes, given the limited resources confronting already under-staffed sites. For sponsors, it's about improved patient compliance, cost-effective trials, and successful and more rapid trial completion. All of this, while maintaining regulatory compliance, in a fast-evolving environment. This session will review and provide guidance on the current state of DCT initiatives, including the service and technology components currently evolving to facilitate deployment across regional NSW, and more broadly in Asia Pacific.

Biography

Dr Jon Carrano is the Managing Director of Pharmsite, a Sydney-based company he founded in 2014 to represent leading international eClinical solutions providers. He collaborates with global teams to deliver cutting-edge digital health technologies to Australian and New Zealand clients. Before establishing Pharmsite, Jon held senior regional leadership roles, including General Manager and Director for Australia and Asia (excluding Japan), with top-tier U.S.-based technology innovators. Over nearly two decades, he built and led high-performing teams supporting pharmaceutical companies, CROs, and academic research organisations, with a strong focus on clinical trial platforms and pharmacovigilance solutions. His work played a key role in advancing eClinical systems and driving the global transition from paper-based to digital clinical processes. From 2010, Jon served as a Senior Director at Oracle and was part of the MyHealthRecord project team. He has maintained a strong interest in health informatics and, until recently, chaired the NSW Committee of the Australian Institute of Digital Health (AIDH). Earlier in his career, Jon worked in research across several universities and biotechs, contributing to fields such as autoimmune disease, neurobiology, monoclonal antibody development, diagnostic instrumentation, and biotech software development. With over 30 years of experience at the intersection of clinical research and technology, Jon is passionate about mentoring emerging talent, fostering innovation within Australia, and promoting Australian technology globally. He has been an active member of ARCS Australia for more than 20 years, participating in and convening several special interest groups and regularly contributing to ARCS events. Jon holds a PhD in Immunopathology from the University of Western Australia. His scientific credentials are complemented by an MBA from Macquarie University and graduate qualifications in corporate governance from the Australian Institute of Company Directors (GAICD).
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Anna Hartley
Project Lead
Decentralised Clinical Trials for the R3-CTEP Program, Cancer Institute NSW

Decentralized Clinical Trials (DCT) – welcome to the DCT steamboat, select your favourite ingredients!

Abstract

Post-COVID, the conduct of DCT’s (Decentralised Clinical Trials) has been boosted by recent regulatory guidance from FDA and other jurisdictions. This has spurred further harmonisation and innovation and provides an opportunity for Australia, and our Asian neighbours, to capitalise on participation in global trials. Convergence in Digital Health Technologies (DHTs), including telehealth, data-interchange standards, and generative AI, as well as innovations in wearables and in-home medical devices, all underpinned by connectivity and secure cloud platforms, present a plethora of alternatives. Given this increasing smorgasbord of offerings, the challenge is navigating the diverse menu within budget, to find the best mix of DCT ingredients to ensure optimal trial conduct and patient outcomes. While the objectives are clear for the various stakeholders, the flexibility and terminology can be confusing. For patients, the aim is efficient recruitment across a wider range of trials, operational efficiencies, and optimal clinical outcomes. For sites, it's about increasing trial capacity and streamlining processes, given the limited resources confronting under-resourced sites. For sponsors it's about improved patient compliance, cost-effective trials, and successful and more rapid trial completion. All of this, while maintaining regulatory compliance, in a fast-evolving environment. This session will review and provide guidance on the current state of DCT initiatives, including the service and technology components currently evolving to facilitate deployment across regional NSW, and more broadly in Asia Pacific.

Biography

Anna is the Project Lead for the Decentralised Clinical Trials Project which is a partnership between Cancer Institute NSW and the Rural Regional and Remote Clinical Trials Enabling Program (R3 CTEP). The project aims to develop a statewide framework for the conduct of decentralised clinical trials across NSW and ACT, leveraging the skills and expertise of the clinical trial workforce in regional, rural and remote areas. Anna has a long history of project management for health services, with a clinical background in Allied Health working at hospitals in Victoria and NSW, working on projects for shared health services, the disability assistive technology sector and the clinical trials program for Cancer Institute NSW.
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Erin Haumann
CEO
Medtryx & Evrima

Decentralized Clinical Trials (DCT) – welcome to the DCT steamboat, select your favourite ingredients!

Biography

Erin Haumann is the CEO of Medtryx, a boutique Australian CRO specialising in early-phase clinical trials and decentralized trial solutions. Her role also encompasses working with Evrima to support sites in clinical study recruitment efforts. With over 25 years’ experience across clinical operations, project management, and data strategy, Erin has overseen trials across a range of therapeutic areas and phases. Erin has deep expertise in the design and operational delivery of decentralized and hybrid trials. She has worked with both local and international sponsors to implement DCT models that incorporate telehealth, remote monitoring, direct-to-patient services, and digital recruitment strategies. Her practical, participant-focused approach has helped global biotech clients navigate regulatory and logistical challenges to bring decentralized elements into real-world implementation — particularly across the diverse regulatory landscape of the Asia-Pacific region.
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