The Strategic Knowledge to Overcome Complex Challenges and Plan for Success
Clients planning cardiovascular outcomes studies face a variety of challenges related to patient recruitment, study design, conduct, data quality and the ensuing high cost. PPD® Consulting offers the strategic development expertise, global access and operational infrastructure to ensure your cardiovascular outcomes studies are of high quality and completed efficiently and on time.
We draw on the extensive expertise of our therapeutically aligned team of medical, safety, scientific, statistical, project management and regulatory experts to provide the optimal strategies for the design and execution of cardiovascular outcomes studies, incorporating the most recent applicable regulatory guidance. From single studies to full development programs, we provide strategic support and oversight at every stage to preserve efficiency, diminish risks and assure that program objectives are met.
Extensive Cardiovascular Outcomes Experience
PPD’s experience includes cardiovascular outcomes research in support of therapies developed to treat cardiovascular disease, including acute coronary syndrome, heart failure, stroke and related diseases such as diabetes, hyperlipidemia/dyslipidemia and obesity. During the past five years, PPD has conducted 11 cardiovascular outcomes studies involving more than 83,000 patients and 8,100 sites. Also, in the past five years, PPD has conducted studies in the following areas relevant to cardiovascular outcomes studies:
- More than 100 cardiovascular studies, including 12 large, complex cardiovascular studies
- Involving 76,000 patients and 79,600 sites
- 18,200 patients and 1,000 sites across 41 countries in a single trial
- More than 50 Type 2 diabetes mellitus studies
- Involving 33,000 patients and 6,400 sites
- More than 65 critical care studies
- Involving 10,000 patients and 1,500 sites
- Including trauma, sepsis and stroke
Our experience allows PPD to provide insight on issues unique to cardiovascular outcomes research such as processes for efficient event identification and adjudication, risk-based monitoring, use of unique technology to more efficiently conduct the studies, and experience with a variety of academic research organization (ARO) partnership models.
PPD’s team of experts – including industry-leading cardiologists, product development experts, statisticians and others – works closely with you to understand your study objectives and timelines, so we can help you define appropriate endpoints. PPD’s years of experience and data on incidence and event rates help you develop optimized protocol designs and determine the best patient populations and centers, as well as the necessary clinical trial patient recruitment strategies to ensure you secure the data required to complete your study successfully on time.