Cardiovascular CRO Services
Advancing treatments for cardiovascular disease
Cardiovascular disease claims more lives globally than any other cause, yet new treatments have steadily declined for two consecutive decades, leaving a void in the fight against this global health threat.
To achieve much-needed breakthroughs in cardiovascular research — for the benefit of the millions of patients affected by these diseases — drug developers need an experienced cardiovascular CRO partner. By leveraging the expertise of the PPD™ clinical research business of Thermo Fisher Scientific, you gain deep experience in Phase I–IV cardiovascular clinical trials across a broad range of drug classes and will be empowered to advance your development goals and create safer, more effective treatments.
Our combined cardiovascular, metabolic and critical care expertise enables seamless delivery of successful cardiovascular development programs in an increasingly complex landscape, cross-therapeutically and in acute and chronic settings. Our areas of expertise include:
- Atherosclerosis
- Cardiomyopathies (including heart failure)
- Dyslipidemias
- Hyperlipemia
- Hypertension
- Obesity
- Rare disease
- Type 1 and type 2 diabetes
With a proven track record in cardiovascular drug development, our patient-centric solutions combine a dynamic, forward-thinking approach with a comprehensive suite of capabilities and operational resources to overcome challenges and accelerate your success.
Proven cardiovascular disease experience
Cardiovascular studies
Patients
Global sites
Cardiovascular outcomes and MACE studies
Overcome the challenges of cardiovascular drug development with confidence
Cardiovascular disease studies present complex challenges for drug developers. As your assured, experienced CRO partner, we enable you to navigate those challenges by:
- Designing efficient trials to meet the regulatory demand for direct assessment of risks and benefits using novel endpoints
- Identifying target patient populations through our global network of more than 160 dedicated clinical research sites, several of which are located near a 125,000-person retirement community in Florida
- Recruiting patients with cardiovascular disease, risk factors and comorbidities through our 100-million-household database of opted-in and fully identified patients
- Providing real-world evidence to determine if your trial is sufficiently powered to stand up to regulatory and academic standards.
Gain expertise across all phases
From early-phase studies to post-approval studies, cardiovascular drug developers need a CRO partner that can do it all. Our experts have a wealth of experience across a wide spectrum of cardiovascular diseases, including heart failure, cardiomyopathy, lipid disorders, coronary artery disease and hypertension. With experience ranging from single-site dose explorations to multinational outcomes studies, and from traditional to novel endpoints, our team is equipped with the knowledge to advance your trial.
Strong experience with rare indications, including 12 cardiomyopathy studies in the past five years.
Cardiac-specific biomarker experience
End-to-end studies: Single-site dose explorations to multinational outcomes
Experience with novel endpoints
GLP-1 drug development
Enhance value with outcomes research
In an era of value-based medicine, companies must demonstrate more than drug efficacy. They must establish their drug’s comparative value to competitors across a broad range of parameters, from payor reimbursement to the patient experience.
Over the past five years, our cardiovascular program has conducted cardiovascular disease outcomes studies involving thousands of sites and many patients, including those with comorbid conditions such as type 2 diabetes, acute coronary syndrome, hypertension, hyperlipidemia/dyslipidemia, and obesity.
Executing cardiovascular disease outcomes research requires strong strategic planning and medical, operational, and therapeutic expertise. Our experience includes:
- Standard MedDRA queries specific to major adverse cardiac events (MACE)
- Industry-leading analytics that provide custom guidance and identify potential risks
- Experience with various academic research organization partnership models
- Regulatory experts who understand the changing landscape
- Extensive experience with global type 1 and type 2 diabetes trials
- Statistical modelling and proactive management of events rate and study timelines
- Event adjudication expertise with preferred partnership with GCTP
To recognize the importance of — and to increase the prevalence of cardiovascular event-driven trials — we have formed a cross-functional cardiovascular outcomes trials working group.
Event-driven studies often struggle with accurate timeline predictions due to factors including poor site selection and insufficient event accumulation, which lead to increased time and costs. By modeling enrichment criteria impacts on event rates before finalizing protocols, we help identify optimal sites and boost confidence in enrollment and event timelines.
Our proactive approach includes event rate modeling and recovery planning to keep trials on track. Patient engagement and retention is emphasized throughout the trial, incorporating risk mitigation strategies and design elements to ensure high retention rates, with proven success exceeding 99%.
Access global cardiovascular experts and sites
Conducting large, multinational cardiovascular trials demands far-reaching clinical and operational resources. We provide these resources through an international investigator network that builds and maintains relationships with global study sites, enabling efficient and accurate recruitment of diverse patient populations. Our global network includes:
- Cardiologists, including subspecialists and interventionalists, who have diverse specialties and experience through our international investigator network to accelerate patient recruitment
- A global team of clinical and medical professionals — including in-house cardiologists in the U.S., Latin America, Europe and APAC — with experience conducting a wide range of cardiovascular studies
- A global network of dedicated research sites
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Benefit from our comprehensive cardiovascular imaging capabilities
- Cardiac catheterization
- Cardiopulmonary exercise test (CPET)
- Computed tomography (CT) scan
- Echocardiography (TTE, TEE, stress)
- Exercise stress testing
- Magnetic resonance angiography (MRA)
- Magnetic resonance imaging (MRI)/Cardiac MRI
- Multigated acquisition scan (MUGA) imaging
- Pharmacologic stress testing
- Positron emission tomography (PET)
pharmacologic and stress/rest perfusion,
as well as metabolic imaging - Technetium 99m stress/rest imaging
- Thallium 201 stress/rest imaging