Cardiovascular

Conducting a cardiovascular clinical trial involves careful planning, ethical and regulatory standards, and rigorous data collection and analysis.

Our team have significant experience in:
  • Coronary Artery Disease (CAD)
  • Heart Failure
  • Hypertension and Arrhythmias
  • Hyperlipidaemia

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.

Conducting a cardiovascular clinical trial demands meticulous planning, adherence to ethical standards, and rigorous methodology to generate meaningful and actionable results for improving patient care and advancing cardiovascular medicine.

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

Addressing Common Pain Points Associated with Cardiovascular Clinical Trials 

Cardiovascular trials frequently use composite endpoints, combining several outcomes. This can complicate trial design, analysis, and interpretation.

iNGENū CRO addresses this pain point with Advanced Endpoint Analysis

iNGENū employs sophisticated statistical techniques tailored for composite endpoints, ensuring clarity in outcome interpretation. We also offer consultation on endpoint selection to match trial objectives.

Cardiovascular diseases (CVDs) are prevalent in diverse populations with varying genetic, lifestyle, and comorbidity factors. Ensuring a representative sample can be challenging.

iNGENū addresses this pain point with Long-term Patient Engagement Programs

To mitigate the risks of long follow-ups, we use patient engagement tools and programs, keeping participants informed and motivated throughout the study, thus reducing attrition rates.

Given the nature of CVDs, clinical outcomes might occur years after treatment. This demands prolonged follow-up durations, increasing the risk of data inconsistencies and patient drop-offs.

iNGENū addresses this pain point with Centralised Imaging and Diagnostics

iNGENū boasts a centralised imaging platform with standardised protocols and trained specialists. This ensures consistent imaging techniques, reducing variability, and improving data quality across trial sites.

New cardiovascular drugs or devices may carry unforeseen risks, emphasising the need for rigorous safety monitoring.

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.

Cardiovascular Clinical Trial Resources

iNGENu CRO - Hypercholesterolemia-1

Hypercholesterolemia 

Explore diagnostic criteria, epidemiology, pivotal endpoints, and the challenges of endpoint determination.

Read our whitepaper
iNGENu CRO - Pulmonary Arterial Hypertension Clinical Trials

Pulmonary Arterial Hypertension

Diagnostic criteria, pathophysiology, and pivotal endpoints in Pulmonary Arterial Hypertension clinical trials.

Read our whitepaper

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

iNGENu testimonial-logos-monotone-1

Ready to discuss your Cardiovascular 

Clinical Trial?