CEO of GreenLight Clinical, Dr Robert Lin said the integrated model responds to increasing competition for high-quality clinical trial sites and experienced investigators.
“Running critical functions in parallel, rather than sequentially, enables earlier risk identification and data quality aligned to TGA and FDA expectations from the outset,” Dr Lin said.
“Sponsors need confidence that a study can start quickly, enrol efficiently and generate data regulators can trust — particularly in complex radiopharmaceutical trials.”
By engaging clinicians early in protocol development, the partnership aims to ensure studies are operationally realistic and aligned with real-world clinical practice, reducing the need for amendments and minimising delays once trials are underway.
Turning insight into development
Group Executive Manager, Research, Sophie Mepham PhD said the collaboration strengthens Australia’s position as a destination for high-quality investigator led oncology trials.
“This partnership allows us to shape feasibility, workflow and operational requirements before protocols are finalised,” Sophie said.
“By combining Icon’s investigator leadership with GreenLight Clinical’s regulatory and sponsorship capability, we are creating a more streamlined and reliable pathway for global companies seeking to run oncology trials in Australia — with the ultimate goal of improving outcomes for patients.”
Clinical expertise will play a central role in the model, particularly for theranostics, where imaging schedules, radiation safety and patient selection require careful coordination.
Patient-focused trials
Clinical Director, Molecular Imaging and Nuclear Oncology (Asia Pacific), Dr Nat Lenzo said early clinician involvement helps ensure protocols reflect the realities of patient care.
“When clinicians are involved from the outset, we can help design studies that align with clinical workflows and patient safety considerations,” Dr Lenzo said.
“That leads to more practical trial designs, fewer amendments and a smoother experience for both patients and trial sites.”
