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 associated with these 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 ensure rigorous and efficient trial execution by providing expert oversight on:
Protocol Development
Participant Recruitment
Data Collection
Safety Monitoring
Statistical Analysis
We have access to several FDA-audited Phase 1 CRUs and bioanalytical labs for analytical method development, validation and sample analysis.
Disciplined,
Cost-Efficient Execution
while maintaining the Highest Quality
Local Trials,
Global Approvals
Access FDA Regulatory Expertise
Our Clinical Team has over
120
years
of Combined Clinical Trial Experience
Addressing Common Pain Points Associated with Early-Stage Clinical Trials
Limited Safety and Efficacy Data
Problem:
In early-stage trials, there’s limited data available on the safety and potential side effects of the investigational drug or treatment.
iNGENū CRO addresses this pain point with Advanced Pharmacovigilance Tools and Monitoring Systems:
We employ advanced pharmacovigilance tools and monitoring systems, ensuring real-time tracking of any adverse events. By maintaining a transparent communication line with participants, we ensure early identification and management of potential safety concerns.
Dose Determination
Problem:
Determining the optimal dose that’s both safe and effective can be tricky in the early stages without substantial prior data.
iNGENū CRO addresses this pain point with Adaptive Trial Designs:
Using adaptive trial designs, iNGENū can adjust dosages based on interim results, ensuring the balance between efficacy and safety is optimised throughout the trial duration.
Narrow Patient Population
Problem:
Early-stage trials often focus on a very specific, sometimes rare, patient population which can make recruitment difficult.
iNGENū CRO addresses this pain point with Patient Engagement Programs:
Our recruitment strategies tap into niche patient networks, partnerships with specialty clinics, and patient advocacy groups to identify and engage the right participants promptly.
Biomarker Identification and Validation
Problem:
Early-stage trials often involve the identification and validation of biomarkers for targeted therapies.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Biomarker Identification and Validation:
We employ cutting-edge technology to identify, validate, and monitor biomarkers, paving the way for personalised medicine approaches.
Protocol Amendments
Problem:
Early-stage trials often require flexibility in design to respond to new data or unexpected results, leading to potential protocol amendments.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Adaptive Trial Design:
iNGENū implements adaptive trial designs from the outset, anticipating potential shifts in the trial direction. Our streamlined processes ensure quick protocol amendments with minimal disruptions, maintaining the trial’s integrity and timeline.
The iNGENū CRO Difference
Local Trials, Global Approvals
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval.
Disciplined, Cost-Efficient Execution
iNGENū CRO takes a highly strategic and disciplined approach to clinical research, ensuring that every dollar is directed toward generating meaningful outcomes.
Australian-Headquartered, Asia-Pacific Reach
We provide sponsors with comprehensive trial capabilities across the Asia-Pacific region, offering a seamless combination of cost-efficiency and high-quality clinical trials.
We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have been very happy with all aspects of the management of the clinical trial.
Ready to discuss your Early-Stage Clinical Trials Clinical Trial?