Cardiovascular disease (CVD) claims more lives globally than any other cause, yet new treatments have steadily declined for two consecutive decades1, leaving a void in the fight against this global health threat.
Your compound holds the potential to fulfill an unmet need for safer and more effective drugs to combat diseases of the cardiovascular system, its complications and the risk factors that give rise to it.
At PPD, we help steer you through the multitude of challenges that have impeded cardiovascular drug development and approval by:
- Designing efficient trials to meet the regulatory demand for direct assessment of risks and benefits using novel endpoints
- Identifying older populations through our global network of 160+ dedicated 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
- Real-world evidence assessing whether your trial is adequately powered to show a difference in clinical outcomes to satisfy regulatory authorities, payers and health technology assessments (HTAs)
PPD’s Experience in the Past Five Years
Cardiovascular outcomes and MACE studies
Dedicated research sites
Broad Experience – From Traditional Cardiovascular Studies to Innovative Research
Our global experience spans early-phase studies through post-approval studies and includes a broad range of indications, including rare diseases. Our experience ranges from single-site dose explorations to multi-national outcomes studies and from traditional to novel endpoints.
Strong experience with rare indications, including cardiomyopathy
Cardiac-specific biomarker experience
End-to-end studies: single-site dose explorations to multinational outcomes
Experience with novel endpoints
PROVIDING VALUE THROUGH 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 payer reimbursement to the patient experience.
PPD’s cardiovascular program has conducted CVD outcome studies over the past five years 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.
Our medical, therapeutic and operational experts offer strategic planning and execution of CVD outcomes research, including:
- Standard MedDRA queries specific for major adverse cardiac events (MACE)
- Industry-leading analytics that provide custom guidance and identify potential risks
- Experience with various academic research organization (ARO) partnership models
- Regulatory experts who understand the changing landscape
- Extensive experience with global Type 1 and Type 2 diabetes trials
Global access to cardiovascular experts and sites
Large, multinational cardiovascular trials demand far-reaching clinical and operational resources. We provide these resources through an international investigator network that establishes and maintains relationships with global study sites to enable efficient and accurate recruitment.
- A network of cardiologists, including subspecialists and interventionalists, worldwide who have diverse specialties and experience through our international investigator network to accelerate patient recruitment
- Global team of clinical and medical professionals globally with experience conducting a wide range of cardiovascular studies
- A global network of dedicated research sites
COMPREHENSIVE CARDIOVASCULAR IMAGING CAPABILITIES
- Cardiac catheterization
- Computed tomography (CT) scan
- Exercise stress testing
- Magnetic resonance angiography (MRA)
- Magnetic resonance imaging (MRI)
- Multigated acquisition scan (MUGA) imaging
- Positron emission tomography (PET) pharmacologic and stress/rest perfusion, as well as metabolic imaging
- Pharmacologic stress testing
- Stress echocardiography
- Technetium 99m stress/rest imaging
- Thallium 201 stress/rest imaging
- Transesophageal echocardiography (TEE)
- Cardiac MRIs
- CPET (exercise stress testing)