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Cardiovascular Experience


PPD Experience

Experience

Gain Confidence Through PPD’s Experience

When you partner with PPD for CV research, you not only extend your global reach—you also gain the confidence of working with a partner who has been where you are—and has succeeded.

Regardless of the size or scope of your CV trial, PPD has the experience, operational capacity and global resources required to effectively support protocol development and manage complex trial execution.

During the past five years, PPD conducted:

  • More than 95 CV trials involving approximately 62,000 patients at more than 7,100 sites
  • 11 CV outcomes studies involving more than 51,000 patients at over 4,400 sites

PPD Cardiovascular Experience

CV Outcomes Experience: Minimizing Risk. Meeting Objectives. Ensuring Better Outcomes.

The risks associated with CV outcomes research—including cost and delays—are significant. As your partner, our goal is to minimize these risks and position you for optimal success. Our extensive experience in this area has provided us the opportunity to build solutions that do just that.

Our CV outcomes experience includes the following key indications:

  • Type 2 diabetes
  • Acute coronary syndrome
  • Hyperlipidemia/dyslipidemia
  • Obesity

PPD’s medical, therapeutic and operational experts support strategic planning and execution of CV outcomes research at every stage to increase efficiency, reduce risk and assure that program objectives are met. This support includes:

  • Standard MedDRA queries specific for major adverse cardiac events (MACE)
  • A CV outcomes working group led by experienced cardiologists and clinical scientists
  • Industry-leading analytics that provide custom guidance and identify potential risks
  • Experience with various academic research organization (ARO) partnership models

Advancing Cardiovascular and Metabolic Trials—Safely and Effectively

PPD Cardiovascular Trials Experience

Advancing Cardiovascular and Metabolic Trials—Safely and Effectively In addition to our work in the CV therapeutic area, PPD also has extensive global experience in planning and implementing Phase I-IV metabolic programs. We’ve designed and executed trials in:

  • Type 1 diabetes
  • Type 2 diabetes
  • Diabetes complications

Our work in these areas has allowed us to develop proven solutions for maintaining CV safety in diabetes trials. We have been a major author for multiple Type 2 diabetes clinical development program plans that incorporate the U.S. Food and Drug Administration (FDA) and European Medicines Agency’s (EMA) guidances regarding CV safety.

Additional Resources

In Type 2 diabetes studies with treatment duration lasting longer than four weeks, a provision for hyperglycemia rescue is essential.

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This white paper outlines some of the best practices for addressing CV outcomes studies in diabetes trials.

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Learn how project PPD management strategies contributed to the success of a Phase III randomized, double-blinded CV end point trial executed by multiple vendors.

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Careful planning and technology tools helped PPD overcome budget constraints and aggressive timelines in a global study evaluating the CV safety of a DPP-4 inhibitor.

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