B23. Clinical trial sites perspectives on common challenges and practical solutions

Tracks
Clinical Research Landscape
Thursday, June 13, 2024
4:30 PM - 5:30 PM
Parkside 1

Chair & Speakers

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Dr Yordanka Krastev
Research Operations Manager
Ramsay Hospital Research Foundation

Chair: Clinical trial sites perspectives on common challenges and practical solutions

Abstract

There are common challenges and solutions encountered by clinical trial sites, irrespective of their structure and location.
This panel forum will focus on interactive discussions of clinical research operational questions faced by private and public clinical trial sites and sponsors.
The session will include 4 facilitated interactive group discussions of the following topics:
• Common barriers in clinical trial site operations – private and public site perspectives
• Safety reporting – common challenges and solutions in meeting the obligations under the National Clinical Trials Governance Framework
• Critical success factors for clinical trial teams to perform their role
• Liaising with sponsors and collaborators
At the end of the group discussions, we will hold a final panel session to summarise the key issues and solutions from each group discussion and take-home tips and tools to improve site processes.

Biography

Yordanka is the Research Operations Manager at the Ramsay Hospital Research Foundation where she is responsible for the execution of key research strategic initiatives across Ramsay Health Care. She is a medical doctor, has a degree in health management and a PhD in medical ethics. Her 15 years’ expertise in Australian higher education sector and healthcare industry, extends from streamlining of research ethics and governance frameworks to implementation of efficiencies in current research management practices. Yordanka has presented nationally and internationally on research ethics, governance and integrity. She is a member of the Australasian Research Management Society (ARMS) Board, Chair of the ARMS Member Services Standing Committee and ARMS Training Fellow.
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Mr Andrew McFadzen
Clinical Trials Network Manager
Ramsay Health Care

Clinical trial sites perspectives on common challenges and practical solutions

Biography

Andrew is the Clinical Trials Network Manager for Ramsay Health Care tasked with the national management of the 20 Clinical Trials & Research Units within the Ramsay Health Care Network. With experience of over a decade in clinical nursing in Hematology & Oncology, he is passionate in supporting site activities to see research translate in improved patient treatments and outcomes to improve their overall quality of life. Over the last 14 years he has focused his career on the development & growth of Clinical Trials Units in both the public & private health sector from establishment. Andrew is involved in a number of quality improvement projects to assist Ramsay CTRU sites deliver best practice and standards of care for their participants in Clinical Trials & Research within the Australian landscape.
Jacinta Stevens
Ramsay Health Care

Clinical trial sites perspectives on common challenges and practical solutions

Biography

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Lien Lombardo
Clinical Trial Support Unit Manager
Western New South Wales Local Health District

Clinical trial sites perspectives on common challenges and practical solutions

Biography

Lien Lombardo is the Western Cluster Clinical Trial Support Unit Manager for Western NSW Local Health District (WNSWLHD). The Western Cluster CTSU is a newly established support unit, supporting Investigators and clinical trial units to build clinical trial capacity and capabilities in WNSWLHD, Nepean Blue Mountains LHD and Far West LHD. This is part of the Rural, Regional and Remote (R3) Clinical Trials Enabling Program (R-CTEP), supported by the Medical Research Future Fund (MRFF) funding, with aims to bring clinical trials closer to home for those living in regional NSW. Lien has extensive experience in coordinating clinical trials in public health service and has a keen interest in supporting clinical trial units to develop strong site governance in conducting clinical trials. In her current role, the CTSU is building a support model to enable all key stakeholders, including clinicians, sponsors and other partners to sustainably bring clinical trials to regional NSW to improve patient outcomes.
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Mr Victor Zhang
Associate Director
BeiGene

Clinical trial sites perspectives on common challenges and practical solutions

Biography

I am Victor Zhang, a veteran of Clinical Operations in pharmaceutical companies and CROs. As the Associate Director of Clinical Operations at APAC BeiGene Australia, I lead one of the experienced, dynamic, and creative Regional Clinical Study Managers teams. I echo BeiGene's core value of “patients first.” We persist in striving to create high-quality, innovative medicines faster and more affordably for patients. It’s not enough for innovative drugs to simply exist; we are determined to ensure patients can access them. I have enjoyed my career in Clinical Research, developing incredible new medicines since 2003. I also enjoyed my local clinical nursing practice before I joined the Pharmaceutical industry and my overseas clinical medical practice before I moved to Australia. In recent years with BeiGene, I have enriched and extended my early phase experiences in oncology/hematology from FIH/Dose Escalation to phase II and III studies and people management and supervision as a full-time Line Manager. Our FIH/Dose Escation management and execution is one of the best. I have been honored to be part of the team that grows and celebrates the launch of our innovative medicines globally and regionally.
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