We’ve contributed to the successful approval of eight marketed cardio-metabolic drugs.
We provide clinical program development, study design, and regulatory agency interactions for our partners’ cardio-metabolic drug development needs. Our non-clinical work covers all aspects of clinical development from feasibility and translational medicine to post-marketing analysis and reporting.
NON-CLINICAL CARDIO-METABOLIC PROJECTS20+
Achieving milestones with expert care and custom-built strategies.
Our in-house therapeutic experts leverage their existing relationships with leading investigators and key opinion leaders in cardio-metabolic diseases to effectively execute patient recruitment and site management and support strategies tailored to meet your unique needs. We have a thorough understanding of standards of care and critical success factors, and our experts have experience in comparatively rare indications, including pulmonary hypertension and acute peripheral arterial occlusion.
Our team training materials for monitoring study-specific diagnostic requirements include:
- Electrocardiogram (ECG)
- Cardiac Magnetic Resonance Imaging (MRI)
- Single Photon Emission Computed Tomography (SPECT)
- Diagnostic Heart Catheterization
Supporting type 2 diabetes research.
With more than 25% of our cardio-metabolic work being in type 2 diabetes support, we have the proven expertise to maximize best practices and operational efficiencies during studies. We’ve conducted studies with at least 30 compounds developed for the treatment of type 1 or type 2 diabetes or metabolic syndrome, and the majority of our Phase I and II studies were performed in our clinical pharmacology units in the Netherlands and the US.Read more about how we’ve met challenging recruitment goals for type 2 diabetes studies.
Challenges Arise as the Need for Pediatric Research Increases
Many modern providers prescribe off-label treatment to children with “guesstimated” doses, because these drugs have often only been studied in…
Multi-Stakeholder Collaborations Can Minimize Barriers & Drive Rare Disease Clinical Programs to Better Patient Outcomes
Conducting clinical trials in rare diseases and advancing research pipelines requires a collaborative, multi-stakeholder approach. This process…
Labs and Clinics
We provide end-to-end bioanalytical support from Pre-clinical to Phase IV studies. At PRA, our laboratories are managed, staffed, and supported by…