We draw a focus upon achieving endpoints such as reduced cardiovascular events, increased survival, and improved quality of life in conjunction with working with independent experts who oversee trial safety and the production of efficacy data.
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
Explore diagnostic criteria, epidemiology, pivotal endpoints, and the challenges of endpoint determination.
a detailed analysis of the epidemiology, pathophysiology, and regulatory landscape of HFrEF.
Diagnostic criteria, pathophysiology, and pivotal endpoints in Pulmonary Arterial Hypertension clinical trials.
Problem:
Cardiovascular trials frequently use composite endpoints, combining several outcomes.
iNGENū CRO addresses this pain point with Advanced Endpoint Analysis:
iNGENū employs sophisticated statistical techniques tailored for composite endpoints, ensuring clarity in outcome interpretation.
Problem:
Cardiovascular disease affects a wide demographic, requiring diverse patient recruitment.
iNGENū CRO addresses this pain point with Global Recruitment Networks:
We leverage our extensive network to recruit diverse patient populations efficiently.
Problem:
Many cardiovascular trials require extended follow-up periods to assess long-term outcomes.
iNGENū CRO addresses this pain point with Patient Retention Programs:
We implement comprehensive patient retention strategies to maintain engagement throughout extended studies.
Problem:
New cardiovascular drugs or devices may carry unforeseen risks, emphasising the need for rigorous safety monitoring.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with Rigorous Cardio-Specific Safety Protocols:
Our specialised cardiovascular safety team, armed with cutting-edge monitoring technologies, focuses exclusively on cardiovascular risk factors and outcomes. This ensures any potential issues linked to new interventions are quickly identified and addressed.
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 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.