We know the importance of objective and subjective pain assessments, safety measures related to sedation and anaesthesia, and biomarkers of pain and inflammation.
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
Bridging the Past and Future of Treatment Strategies. From pivotal endpoints to enhancing trial success.
Evolving Insights into Acute Pain Diagnosis and Treatments. Understanding clinical trial strategies.
Safety, Efficacy, and Regulatory Considerations in Fibromyalgia Clinical Trials.
Improving POP Clinical Trials: Pivotal Endpoints, Failures, and Protocol Enhancements.
Addressing Clinical Trial Challenges from Diagnosis to Enhanced Protocols.
Problem:
Finding suitable patients who meet the specific criteria for anaesthesia and pain medicine trials can be challenging.
iNGENū CRO addresses this pain point with Enhanced Recruitment Strategies:
iNGENū leverages advanced patient databases to identify suitable candidates rapidly. We ensure continuous engagement and use patient-centric approaches, such as flexible scheduling and remote monitoring, to maximize retention.
Problem:
Given the subjective nature of pain, placebo effects can be profound in pain medicine trials. Ensuring effective blinding can be challenging.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Robust Blinding Methodologies:
iNGENū designs trials with robust blinding methodologies, minimising potential biases. We also use advanced statistical techniques to account for and analyse placebo responses, ensuring the integrity of the trial results.
Problem:
Pain is subjective, and its measurement can vary between patients and evaluators.
iNGENū CRO addresses this pain point with Standardisation:
We implement standardised and validated pain assessment tools. We also offer training sessions for clinical staff on the consistent use and interpretation of these tools, ensuring uniformity across all trial sites.
Problem:
As anaesthesia and pain medications often have systemic effects, monitoring for adverse events is critical.
iNGENū CRO addresses this pain point with Safety Monitoring:
We employ state-of-the-art safety monitoring systems and protocols. Our dedicated safety board reviews data in real-time, ensuring rapid response to any adverse events.
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval.
iNGENū CRO takes a highly strategic and disciplined approach to clinical research, ensuring that every dollar is directed toward generating meaningful outcomes.
We provide sponsors with comprehensive trial capabilities across the Asia-Pacific region.
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.