Clinical trials in diabetes, metabolic disorders, and endocrinology play a vital role in advancing our understanding of these conditions and improving patient care.
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
Navigating the complex landscape of Obesity Clinical Trials, including pivotal endpoints, and enhance protocols.
Explore diagnostic criteria, epidemiology, pivotal endpoints, and the challenges of endpoint determination.
Problem:
Diabetes, metabolic, and endocrine disorders are heterogeneous in their progression. The variable disease patterns can affect the consistency of study results.
iNGENū CRO addresses this pain point with iNGENū CRO addresses this pain point with Tailored Patient Segmentation:
iNGENū employs stratified patient selection, ensuring participants have a similar disease progression stage, providing more consistent results.
Problem:
Dietary habits, exercise routines, and other lifestyle factors play significant roles in these conditions, making it challenging to maintain consistency across participants.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Dietary and Lifestyle Standardisation:
We collaborate with nutritionists and lifestyle experts to create standardised guidelines for participants during the trial. This reduces variability and ensures consistency in external influences.
Problem:
Given the chronic nature of these conditions, trials often require long-term monitoring, which can lead to attrition and inconsistencies in treatment adherence.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Long-Term Support and Engagement Platforms:
We have developed a comprehensive patient support platform, specifically for diabetes and endocrine patients, that includes regular check-ins, reminders, and educational resources to boost long-term compliance.
Problem:
Endocrine trials face challenges with hormonal fluctuations in participants, which can influence study outcomes.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Hormone Monitoring Protocols:
Our trials in the endocrine space include rigorous hormonal monitoring, using advanced hormonal assays to account for and manage hormonal fluctuations, ensuring that they don’t interfere with trial outcomes.
Problem:
Many patients with these disorders are on multiple medications. Interactions between study drugs and existing medications can pose safety concerns and skew results.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Detailed Medication Review:
Before enrolment, we conduct a thorough review of a participant’s medication regimen. This not only helps in selecting the right participants but also in predicting and monitoring potential drug interactions.
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.