Cardio-Metabolic

PRA has provided services critical to the approval of 7 marketed cardio-metabolic drugs. PRA’s cardio-metabolic experts provide skillful clinical program development, study design and regulatory agency interactions.

In the past five years, PRA has conducted more than 125 cardio-metabolic studies across 3600+ sites and nearly 55,000 patients around the world.

EXPERIENCE AND Expertise

PRA has conducted close to 125* projects in cardio-metabolic indications during the past five years. Our consulting work has covered all aspects of clinical development from feasibility to translational medicine and post-marketing analysis and reporting.

Cardio-Metabolic Number of Clinical Studies Number of Clinical Sites Number of Clinical Patients
Diabetes 41 118 2,081
Coronary Artery Disease 15 789 7,575
Arrhythmia 13 511 9,382
Hypertension 11 200 1,337
Heart Failure 11 11 271
Atherosclerosis 10 108 1,254
Total 100+ 1,700+ 21,000+

*125+ Phase I-IV clinical trials and also consulting services for more than 50 projects in Cardio-Metabolic indications

VALUE-ADDED SOLUTIONS

PRA’s expertise in cardio-metabolic diseases provides our clients with the following benefits:

  • Existing relationships with leading investigators and opinion leaders in cardio-metabolic diseases
  • Excellent patient recruitment, site management and support strategies
  • Thorough understanding of the standard of care and critical success factors
  • Experience in comparatively rare indications, e.g., pulmonary hypertension and acute peripheral arterial occlusion
  • Team training materials for monitoring of study specific diagnostic requirements, e.g., echocardiography, ECG, cardiac MRI, SPECT and diagnostic heart catheterization
  • In-house therapeutic experts in cardio-metabolic drug development

Type 2 Diabetes Support

  • Accounts for more than 25% of PRA’s work in the cardio-metabolic diseases
  • Uses proven and current diabetes experience to ensure best practices and operational efficiencies are maximized during studies
  • Majority of Phase I/II studies performed in clinical pharmacology units in the Netherlands and United States
  • Studies conducted with at least 30 different compounds developed for treatment of type 1 or type 2 diabetes or metabolic syndrome