Cardiovascular Focused Observational Research

Cardiovascular Focused Observational Research

Cardiovascular Focused Observational Research

A Specialized, Scientific Approach to Cardiovascular Real-World Evidence

Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality globally, creating a critical need for robust real-world evidence to complement clinical trial data. Observational studies in this space demand a specialized, scientific approach to navigate complex patient pathways, treatment patterns, and long-term outcomes. At Omega CRO, our team of cardiovascular specialists is highly skilled in the scientific methodology, standard of care, evolving regulatory requirements, and operational considerations necessary to generate the credible RWE needed to support the life-cycle management of cardiovascular therapies and devices. Our extensive experience in cardiovascular studies and relationships with Key Opinion Leaders (KOLs) provide the knowledge and flexibility to adapt to the unique needs of each cardiovascular outcomes study.

The Omega CRO Advantage for Cardiovascular Studies

Partner with Omega CRO to successfully navigate the complexities of generating real-world evidence for cardiovascular conditions. We bring a global footprint, strategic medical, regulatory, and operational leadership, as well as fully integrated data management and biostatistical services to deliver high-quality, regulatory-grade insights.

Proven Experience in Cardiovascular Epidemiology

Our expertise is demonstrated by a proven track record of successfully managing large-scale, population-based cardiovascular studies. This hands-on experience in epidemiology translates directly into designing and executing robust RWE studies for our clients.

Key Cardiovascular Studies Include

Turkish Acute Myocardial Infarction Registry (TURKMI Study): As a cornerstone national registry, TURKMI was designed to provide up-to-date insights into the characteristics, management, and outcomes of patients with acute MI in Turkey. Conducted across 50 PCI-capable centers with a population-based sampling method, it prospectively enrolled consecutive patients to assess management from symptom onset to hospital discharge, with a 2-year follow-up cohort to evaluate long-term outcomes and guideline implementation. This study highlights our capability in managing complex, multi-center, longitudinal registry studies for acute cardiovascular events.

Hypertension Prevalence Study (PatenT & PatenT2): Conducted with nearly 5,000 volunteers, these landmark studies were pivotal in determining and re-investigating the prevalence of hypertension in Turkey, providing critical national baseline data.

Hypertension Incidence (HinT): Built upon the PatenT population, this study focused on calculating the incidence of new-onset hypertension, offering insights into the progression of this major cardiovascular risk factor.

Chronic Heart Failure Prevalence Study (HAPPY): A crucial investigation into the prevalence and predictors of heart failure within the Turkish population, highlighting the burden of this condition.

Salt Consumption in Turkey (SALTURK): This influential study examined the direct correlation between salt intake and hypertension. Its findings directly informed and prompted the Turkish Ministry of Health’s national initiative to reduce salt content in bread, demonstrating the real-world impact of our research.

Cappadocia Cohort Study: An ongoing cohort study managed to identify chronic disease risk factors, including cardiovascular ailments, in specific regions, providing longitudinal data on disease development.

Cardiovascular RWE Capabilities

Building on this foundational experience, we help our clients effectively plan and conduct cardiovascular studies by:

Designing robust protocols for post-market safety and effectiveness studies.

Efficiently managing large-scale cardiovascular registries that demand rigorous data quality and long-term follow-up.

Seamlessly integrating data from electronic health records (EHR), claims databases, and patient-reported outcomes (PROs).

Providing expert management of Clinical Endpoint Committees (CEC) and Data Safety Monitoring Boards (DSMB).

Integrated Data Management & Advanced Analytics

Omega CRO’s data management and biostatistics teams have unparalleled experience in handling complex cardiovascular data. Our advanced methodologies ensure data integrity and facilitate the transformation of raw, real-world data into meaningful evidence. Our PhD-level biostatisticians and data scientists are available at the protocol design stage to ensure the right endpoints and analytical methodologies are selected to meet your evidence needs, avoiding costly oversights later. We support your programs from feasibility analysis through to final statistical reporting for regulatory submissions.

Robust Cardiac Safety & Outcomes Monitoring

Monitoring long-term safety and effectiveness in a real-world setting is paramount. Omega CRO excels in implementing rigorous safety monitoring plans in line with EMA, FDA, and TİTCK requirements. Our integrated approach, with therapeutic experts, regulatory affairs, and data management working in close collaboration, provides a distinct advantage for managing the complexities of post-market surveillance studies. Early planning with our team ensures that your study is designed to capture the safety signals and outcomes that matter most to regulators, payers, and clinicians.

Cardiovascular Precision Medicine & RWE

The emerging role of precision medicine in cardiovascular disease demands RWE that can identify subphenotypes of patients and their response to treatments in real-world settings. Omega CRO has established a specialized in-house Cardiovascular RWE & Precision Medicine Program. This program comprises experts with extensive knowledge in CVD and advanced analytics, aiming to create a highly specialized partnership with sponsors seeking to understand treatment effects in specific patient subgroups, identify biomarkers for targeted therapies, and develop a more patient-tailored approach to care using real-world data.

QUOTE

"The goal of modern cardiovascular care is to move beyond population-level evidence and understand the individual patient's journey and response to treatment. With Omega CRO’s program, we are excited to work with Sponsors who are using RWE to advance the principles of precision medicine."

Cardiovascular Experts

Our in-house therapeutic experts, including medical doctors and advanced clinical practitioners, provide strategic direction for study design, train operational staff, and ensure the clinical relevance of our data collection and analysis.

Embedded within every study team, they provide medical oversight, review complex patient cases, and work with our global regulatory affairs experts to provide strategic guidance. This embedded model ensures that your study is not only operationally sound but also clinically meaningful, designed with the patient, site staff, and end-goal in mind from the very beginning.