Cardiovascular Studies

Cardiovascular disease remains the leading cause of death and disability worldwide, and the cardiovascular therapeutic area commands the largest market for prescription drugs.

Yet clients conducting research in this area frequently face challenges to patient recruitment and study design, while facing immense competition from other drug sponsors.

As an experienced and reliable outsourcing partner, PPD provides the insight and access you need to overcome these challenges. Our operational capacity and global resources, combined with our vast cardiovascular expertise, enable us to develop effective study protocols and manage complex, global cardiovascular trials.

We help you succeed from start-up to completion
PPD takes a highly consultative approach to understanding the needs of your cardiovascular drug development program from early phases through post-approval.

We apply our deep strategic development expertise in cardiovascular diseases, global resources and vetted feasibility processes to help you gain efficiencies by selecting the best countries, sites and patient populations. Furthermore, we help you align your study protocol with marketing plans to help you realize your product’s greatest value.

Our comprehensive, integrated services include:

• Drug development advisory services
• Protocol review and writing
• Clinical data management
• Individualized project feasibility evaluations
• Seamless project management processes
• State-of-the-art laboratory services
• Cardiovascular (CV) event management, including management of cardiac evaluation centers (CEC) and internal displacement monitoring centers (IDMC)

Rely on a leading network of cardiovascular experts
PPD’s team of more than 1,700 physicians, project managers, clinical team managers and clinical research associates offers extensive cardiovascular specialization. Our worldwide investigator network includes more than 5,000 cardiologists with diverse specialties and experience in cardiovascular clinical trials.

Our experience: single-site dose studies to mega trials
PPD has extensive experience in planning and implementing Phase I-IV programs for cardiovascular drug development projects, ranging from single-site dose exploration studies to multinational outcomes studies with hundreds of sites and thousands of patients.

In the past five years, PPD has conducted more than 200 cardiovascular studies with more than 100,000 patients accrued across more than 8,900 sites and 50 countries.

Global cardiovascular mega trials
Mega trials pose some of the greatest operational challenges in drug development history.

In the past five years, PPD has conducted six global adjudicated, event-driven “mega” trials involving more than 5,700 sites and more than 65,000 patients. From the conduct of these “mega” studies involving the adjudication of endpoints, PPD has developed a proprietary event management and electronic adjudication tool.

Broad Cardiovascular Experience

PPD helps you focus on developing cardiovascular therapies to improve patients’ lives in a variety of areas, including:

• Acute coronary syndrome
• Atrial fibrillation
• Embolism and thrombosis
• Hyperlipidemia
• Hypertension
• Ischemic heart disease
• Peripheral vascular disease
• Stroke
• Ventricular tachycardia

Cardiovascular Device Experience

Whether treating chronic heart failure or finding improved technologies to reconnect arteries, PPD has extensive experience managing cardiovascular device projects, including:

• Angioplasty
• Distal protection devices
• Hemostasis products
• Intracoronary stents (including drug-eluting and bare metal stents)
• Intracoronary temperature measurements
• Radiation therapies
• Ultrafiltration devices
• Vascular grafts
• Wound closure devices

Cardiovascular Imaging Experience

PPD has access to state-of-the-art tests and experience with a full range of advanced imaging technologies including:

• Cardiac catheterization
• Computed tomography (CT) scan
• Echocardiography
• Exercise stress testing
• Magnetic resonance angiography (MRA)
• Magnetic resonance imaging (MRI)
• Multi Gated Acquisition (MUGA) scan 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)