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
  • Hyperlipidemia

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.

Pain points associated with cardiovascular clinical trials

  • Complex Endpoint Evaluation: Cardiovascular trials frequently use composite endpoints, combining several outcomes. This can complicate trial design, analysis, and interpretation.
  • Diverse Patient Populations: Cardiovascular diseases (CVDs) are prevalent in diverse populations with varying genetic, lifestyle, and comorbidity factors. Ensuring a representative sample can be challenging.
  • Long Follow-up Durations: 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.
  • Sophisticated Imaging and Diagnostics: Cardiovascular trials often require advanced imaging modalities like echocardiograms, MRIs, or CT scans, which demand standardized techniques and interpretations.
  • Safety Concerns with New Interventions: New cardiovascular drugs or devices may carry unforeseen risks, emphasizing the need for rigorous safety monitoring.

How iNGENū addresses these pain points

  • 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.
  • 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.
  • Centralized Imaging and Diagnostics: iNGENū boasts a centralized imaging platform with standardized protocols and trained specialists. This ensures consistent imaging techniques, reducing variability, and improving data quality across trial sites.
  • Rigorous Cardio-Specific Safety Protocols: Our specialized 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.
  • Adaptive Trial Designs for Cardiovascular Studies: Recognizing the evolving nature of cardiovascular research, we employ adaptive trial designs. This not only enhances the probability of trial success but also ensures optimal resource utilization, reducing the time and costs associated with cardiovascular trials.
Ready to discuss your trial?