Services
Early-Stage Clinical Trials
Collectively, our senior team have completed over 100 Phase 1 trials in Australia on behalf of US sponsors. We understand the unique challenges of early-stage studies, which focus on safety, tolerability, and occasionally preliminary efficacy.
Critical data points we consider include pharmacokinetic (PK) and relevant pharmacodynamic (PD) measures, biomarkers, safety endpoints, and initial signs of clinical response.
We have access to several FDA-audited Phase 1 clinical research units (CRUs) and bioanalytical labs for analytical method development, validation and sample analysis.
Addressing common pain points in early-stage clinical trials clinical trials
Limited safety and efficacy data
In early-stage trials, there's limited data available on the safety and potential side effects of the investigational drug or treatment.
We employ advanced pharmacovigilance and monitoring systems for real-time tracking of adverse events, ensuring early identification and management of safety concerns.
Dose determination
Determining the optimal dose that's both safe and effective can be tricky in the early stages without substantial prior data.
Using adaptive designs, we adjust dosages based on interim results, balancing efficacy and safety throughout the trial.
Narrow patient population
Early-stage trials often focus on a very specific, sometimes rare, patient population, which can make recruitment difficult.
Our recruitment strategies tap into niche patient networks, specialty clinics, and advocacy groups to engage the right participants promptly.
Biomarker identification and validation
Early-stage trials often involve identifying and validating biomarkers for targeted therapies.
We employ cutting-edge technology to identify, validate, and monitor biomarkers, paving the way for personalised medicine.
Protocol amendments
Early-stage trials often require flexibility to respond to new data, leading to potential protocol amendments.
We anticipate potential shifts from the outset; streamlined processes ensure quick amendments with minimal disruption to timeline and integrity.
Frequently asked questions
Early-Stage Clinical Trials clinical trials — FAQs
Why run early-stage (Phase 1) trials in Australia?
Can I run a first-in-human trial without an open IND?
How many early-stage trials has iNGENū supported?
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Early-Stage Clinical Trials clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
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