We specialise in the design and execution of clinical trials across a wide range of dermatological conditions, ensuring high-quality data capture and patient safety.
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
Overcoming Challenges and Enhancing Protocols in Melanoma Clinical Research.
Diagnosis, Drug Candidates, and Trial Enhancements in Atopic Dermatitis Clinical Trials.
Explore key insights into Epidemiology, Endpoints, and Safety Considerations.
Clinical Endpoints, Safety Concerns, and Therapeutic Innovations.
Insights into overcoming challenges in CLE Clinical Trials.
Problem:
Identifying and engaging patients for dermatology trials, particularly those with rare or stigmatised conditions, can be difficult.
iNGENū CRO addresses this pain point with iNGENū CRO addresses this pain point with Enhanced Recruitment Strategies:
We utilize targeted digital campaigns and partnerships with dermatology clinics to efficiently identify and engage suitable patients.
Problem:
Dermatological assessments often rely on visual inspections, which can be subjective and vary between evaluators.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Objective Skin Assessments:
To reduce subjectivity, we incorporate digital imaging technologies and automated analysis tools in our trials. We also provide thorough training for clinical evaluators to ensure consistent and accurate assessments.
Problem:
The visible nature of many skin conditions can lead to strong placebo responses, complicating the interpretation of trial results.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Robust Blinding and Statistical Techniques:
iNGENū designs dermatology trials with rigorous blinding procedures and applies advanced statistical methods to mitigate placebo effects, ensuring the integrity of trial outcomes.
Problem:
Ensuring consistency in the use of scoring systems such as PASI (Psoriasis Area and Severity Index) or EASI (Eczema Area and Severity Index) across multiple sites can be challenging.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Standardised Scoring Systems:
We standardise the use of scoring systems across all sites, with regular calibration exercises and centralised review processes to ensure uniformity in data collection and analysis.
Problem:
Dermatology trials often involve long-term treatments, necessitating rigorous safety monitoring for adverse effects, especially in chronic conditions.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Comprehensive Safety Monitoring:
Our trials are supported by cutting-edge safety monitoring systems that track patient outcomes in real-time. We prioritise long-term safety, particularly for chronic dermatological conditions, ensuring that patients are protected throughout the study duration.
We uniquely combine Australian expertise with direct FDA submission capabilities.
iNGENū CRO takes a highly strategic approach to clinical research.
We provide sponsors with comprehensive trial capabilities.
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.