Cardiovascular Experience

CV Outcomes Experience: Minimising 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 minimise 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
Cardiovascular Experience

Our 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 organisation (ARO) partnership models

Advancing Cardiovascular and Metabolic Trials—Safely and Effectively

Advancing Cardiovascular and Metabolic Trials—Safely and Effectively In addition to our work in the CV therapeutic area, GCR 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.