心血管聚焦观察性研究
针对心血管真实世界证据的专业科学方法——驾驭复杂的患者路径、治疗模式和长期结果。
心血管真实世界证据的专业化科学方法
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.
Omega CRO心血管研究优势
全球布局
具有战略医学、法规和运营领导力的全球布局,提供高质量、监管级别的见解。
一体化数据管理
完全集成的数据管理和生物统计服务,用于全面的真实世界证据生成。
经验证的流行病学经验
在成功管理大规模人群心血管研究方面拥有良好记录。
关键心血管研究
我们的专业知识体现在成功管理大规模、人群基础心血管研究的经验证记录中。
土耳其急性心肌梗死登记(TURKMI研究)
A cornerstone national registry 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.
高血压患病率研究(PatenT和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.
高血压发病率(HinT)
基于PatenT人群的这项研究专注于计算新发高血压的发病率,为这一心血管危险因素的进展提供了见解。
慢性心衰患病率研究(HAPPY)
一项关键调查,研究土耳其人群中心力衰竭的患病率和预测因素,突出这一疾病的负担。
土耳其食盐摄入量(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.
卡帕多西亚队列研究
一项正在进行的队列研究,旨在特定地区识别慢性病风险因素(包括心血管疾病),提供疾病发展的纵向数据。
心血管RWE能力
基于这一基础经验,我们帮助客户有效规划和开展心血管研究。
方案设计
为上市后安全性和有效性研究设计稳健的研究方案。
登记库管理
有效管理需要严格数据质量和长期随访的大规模心血管登记库。
数据整合
Seamlessly integrating data from electronic health records (EHR), claims databases, and patient-reported outcomes (PROs).
终点委员会
提供临床终点委员会(CEC)和数据安全监查委员会(DSMB)的专业管理。
Omega生态系统中的应用场景
How Omega\u2019s integrated ecosystem supports cardiovascular research\u2014from coagulation and lipid panels to long-term biomarker storage.
HelixLab
Cardiac Biomarker Panels
Protocol-driven lipid profiles (LDL, HDL, triglycerides), high-sensitivity troponin, NT-proBNP, CK-MP, and hs-CRP with standardized pre-analytical workflows across all sites.
Omega Genetics
Pharmacogenomic Profiling
CYP2C19 and CYP2D6 genotyping for antiplatelet therapy response prediction; familial hypercholesterolemia (FH) variant screening (LDLR, APOB, PCSK9).
Omega生物样本库
Long-Term Biomarker Storage
Multi-temperature biobanking of serial serum/plasma samples for extended follow-up studies, enabling retrospective biomarker analysis in registry cohorts.
Omega Care
Post-Discharge Home Follow-Up
Home-based blood sampling for INR monitoring in anticoagulation studies and remote collection of patient-reported outcomes after acute cardiac events.
Omega Bio
Standardized Cardiac Assay Kits
Kit-based analytical standardization for cardiac troponin and lipid panel harmonization across multi-center registries with lot-to-lot consistency.
动物设施
Preclinical Cardiac Safety
GLP-compliant cardiotoxicity studies (hERG, in vivo telemetry) and atherosclerosis models to support early-stage cardiac drug development before clinical transition.