PRA has provided services critical to the approval of five marketed cardio-metabolic drugs: Prandin®, Symlin®, Cleviprex®, Olmetec Plus® and Letairis®/Volibris®.
PRA's cardio-metabolic experts provide skillful clinical program development, study design, and regulatory agency interactions. Experience and Expertise PRA has conducted more than 200* 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.
Key Areas of Cardio-Metabolic Expertise
*130 Phase I-IV clinical trials and also consulting services for more than 60 projects and 20 studies in Cardio-Metabolic indications
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 20% 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