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:
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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

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:
early stage clinical trials icons_protocol develop icon-iNGENū CRO
early stage clinical trials icons_statistical analysis icon-iNGENū CRO
early stage clinical trials icons_safety monitoring icon-iNGENū CRO
early stage clinical trials icons_data collection icon-iNGENū CRO
early stage clinical trials icons_participant recruitment icon-iNGENū CRO

We have access to several FDA-audited Phase 1 CRUs and bioanalytical labs for analytical method development, validation and sample analysis.

Addressing Common Pain Points Associated with Early-Stage Clinical Trials 

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.

Determining the optimal dose that's both safe and effective can be tricky in the early stages without substantial prior data.

iNGENū 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.

Early-stage trials often focus on a very specific, sometimes rare, patient population which can make recruitment difficult.

iNGENū 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.

Early-stage trials often involve the identification and validation of biomarkers for targeted therapies.

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.

Early-stage trials often require flexibility in design to respond to new data or unexpected results, leading to potential protocol amendments.

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

iNGENu - FDA
Local Trials, Global Approvals

We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Our seamless integration allows trial data from Australia to be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.

iNGENu - cost efficient
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. Our trials are designed with efficiency in mind, eliminating unnecessary costs while maintaining the highest scientific and regulatory standards.

iNGENu - APAC
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 leverage the region's competitive pricing while maintaining rigorous Australian-based project management and clinical oversight.

"We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have used iNGENū for: Medical writing, project management, clinical data management and full end-to-end, clinical trial execution and monitoring.

We have been very happy with all aspects of the management of the clinical trial and have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads for our company during this clinical trial."

Giles Moss
Chief Executive Officer

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Ready to discuss your Early-Stage Clinical Trial?

 
Ready to discuss your trial?