Trials Without Tribulations 2025

Published on:

The Sibyl Centre, Women's College, University of Sydney

SOLD OUT!

Sydney Health Partners’ sell-out event for the clinical trials workforce, Trials Without Tribulations, will be held at the Sibyl Centre of the University of Sydney Women’s College on August 1.

Now in its third year, the Trials Without Tribulations has earned a reputation as a unique gathering of clinical trials professional staff from across the partnership. Together we share and address some of the challenges and enablers of conducting health and medical research trials in clinical settings.

This year’s event will discuss new trends in clinical trials design, preparation for gene therapy trials and special considerations for clinical trials involving medical devices - and what they mean in practice for those who work in the sector.

The workshop will also discuss what can be done to better support professional development and career continuity of clinical trial staff.

During the workshop section of the day, attendees will have the choice of two breakout sessions on:

• Writing and implementing Standard Operating Procedures (SOPs). This session is relevant to managers and senior staff who review and write SOPs.
• GCP in Action: Everyday Practice and R3 Readiness. This session is aimed at staff looking to strengthen their GCP knowledge or learn about upcoming changes.

Full details of the program and speakers can be found below.

This is a must-attend event for anyone working professionally in clinical trials. Certificates of Attendance, which can be used as evidence of professional training for 6 hours, will be issued to all participants.

Places are limited and will be prioritised for trial managers and coordinators within SHP’s member organisations.

Program

Registration: 8:50 – 9:20 am

Opening Remarks – 9:20 – 9:30 am | Associate Professor Angela Todd, Research Director, Sydney Health Partners

Session 1: Clinical Trial Designs: What’s Changing and What It Means for Us - 9:30 – 11:00 am
Chair: Associate Professor Angela Todd, Research Director, Sydney Health Partners

Gearing Up for Gene Therapy Trials: Practical Steps and Considerations | Dr Michelle Lorentzos, Advanced Therapeutics Medical Lead, Sydney Children's Hospitals Network

Oversight in Medical Device Trials: Getting It Right | Professor David Cook, Clinical Trials Support and Governance Lead, Sydney Local Health District

Smarter Trials, Better Outcomes | Dr Mun Hui, Staff Specialist Medical Oncology and Phase 1 Clinical Trial Lead, Chris O’Brien Lifehouse

Operationalising Adaptive Designs in Clinical Trials: Lessons from BEAT-Calci | Aneeka Ratwatte, Trial Operations Coordinator, NHMRC Clinical Trials Centre, The University of Sydney

Discussion Panel - Innovative Trials in Practice: Operational Realities and Lessons Learned | Chair: Danielle Somers, Director Research Methods and Clinical Trials, Office for Health and Medical Research, NSW Health

  • Aneeka Ratwatte, Trial Operations Coordinator, NHMRC Clinical Trials Centre, The University of Sydney 
  • Sarah Thompson, Clinical Research Nurse Specialist 2, Kids Research, Sydney Children’s Hospitals Network 
  • Pauline Hanrahan, Risk and Governance Manager Clinical Trials, Office of the Pro-Vice Chancellor (Research), The University of Sydney 
  • Heidi Buhr, Clinical Nurse Consultant, Intensive Care Research, Royal Prince Alfred Hospital 

11:00 – 11:30 am: Morning Tea

Session 2: Behind the Scenes: Strengthening Operations and Supporting the Clinical Workforce - 11:30 am – 12:50 pm
Chair: Dr Helen Goldsmith, Research Development Manager, Sydney Children's Hospitals Network

Behind the Trials: A Snapshot of Today’s Clinical Workforce | Associate Professor Angela Todd, Research Director, Sydney Health Partners 

Leading Performance, Development and Talent Management | Adam Steggles, Senior Human Resources Business Partner, Northern Sydney Local Health District 

Discussion Panel – Own Your Path: Smart Strategies for Career Growth and Promotion | Chair: Dr Helen Goldsmith, Research Development Manager, Sydney Children's Hospitals Network

  • Adam Steggles, Senior Human Resources Business Partner, Northern Sydney Local Health District
  • Dr Kelly Thompson, Director Research Operations, Nepean Blue Mountains Local Health District
  • Tanya Cao, Clinical Trials Coordinator - Medical Oncology Clinical Trials Unit, Westmead Hospital
  • Anthony Jaworski, Associate Director, Trial Operations, NHMRC Clinical Trials Centre, The University of Sydney

Towards Inclusive Research: Starting the Conversation on Diversity in Clinical Trials | Associate Professor Danielle Muscat, Applied and Translational Research Lead, Sydney Health Literacy Lab, The University of Sydney

12:50 – 1:50 pm: Lunch

Session 3: Concurrent Breakout Sessions – 1:50 - 2:50 pm

Breakout Session #1  

Writing and implementing Standard Operating Procedures (SOPs) | Chair: Sharon Lee, Manager, Research Strategy and Partnerships, Northern Sydney Local Health District

This session covers the key components of developing audit-compliant SOPs, offering industry insights and practical guidance for implementation and training. It will also identify the SOPs required for clinical trials, aiming to help organisations build a suite of compliant SOPs. The session is relevant to managers and senior staff who are responsible for reviewing and writing SOPs.

Facilitators:  

  • Sharon Lee, Manager, Research Strategy and Partnerships, Northern Sydney Local Health District 
  • Liz Wilson, Director Strategic Site Relationships, IQVIA 
  • Sara Moldovan, Associate Director, Quality Management ANZ, IQVIA 

Breakout Session #2  

GCP in Action: Everyday Practice and R3 Readiness | Chair: Erfan Jaberiyanfar, Research Business Unit Manager, Nepean Blue Mountains Local Health District

This session covers the practical application of Good Clinical Practice (GCP) in clinical trials and previews key changes in ICH GCP E6(R3), with interactive activities, local insights, and preparation tips for the rollout. The session is ideal for those new to clinical trials seeking a stronger foundation, or anyone keen to learn about the upcoming GCP changes.

Facilitators:

  • Erfan Jaberiyanfar, Research Business Unit Manager, Nepean Blue Mountains Local Health District 
  • Mel Grand, Clinical Trials Operations and Business Manager, Kids Research, Sydney Children’s Hospitals Network 
  • Haleh Shahidipour, Clinical Research Centre Manager, Research and Education Network, Western Sydney Local Health District 
  • Allison Sigmund, Research Education and Training Support Manager, Western Sydney Local Health District 

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Session 4: Trials Without Tribulations 2024: Reports and Reflections from This Year's Working Groups – 3:00 - 3:30 pm 
Chair: Alison Rego, Clinical Trials Project Manager, Sydney Health Partners

Facility and Unit Profile Templates (Site CV) | Penny Mahairas, Clinical Trials Unit Manager, Nepean Blue Mountains Local Health District & Aimei Lee, Clinical Trials Manager
Cell and Molecular Therapies, Royal Prince Alfred Hospital 

Patient Reported Experience Measures (PREMs) template for Clinical Trials | Akila Dharmendar, Clinical Trials Business Manager, Sydney Local Health District & Sadia Mahboob, Quality Manager (Clinical Trials), Northern Sydney Local Health District 

Closing Remarks: 3:30 - 3:40 pm | Associate Professor Angela Todd, Research Director, Sydney Health Partners