Over the last 30 years, PRA has supported the development of treatments for cardio-metabolic diseases. As a recognized leader in this therapeutic area, we have provided services critical to the approval of five marketed cardio-metabolic drugs: Prandin®, Symlin®, Cleviprex®, Olmetec Plus® and Letairis®/Volibris®.
Experience and Expertise in Cardio-Metabolic DiseasesPRA’s therapeutic and operational experts develop targeted strategic recommendations for each cardio-metabolic study. Leveraging their understanding of indication-level success factors, our team applies this knowledge to the specific protocol resulting in a plan tailored to the client’s study requirements. Examples of success factors include: • protocol and study design considerations • strategic country and site selection using novel database analytics • proactive patient recruitment and retention strategies • integrated project management by an experienced global team > Extensive worldwide network of cardio-metabolic In the past five years, PRA has conducted over 130 Phase I-IV clinical trials involving over 2,200 sites and nearly 20,000 subjects. In addition, we have provided consulting services for more than 60 projects. Our clinical study experience includes 20 indications across multiple indication groups.
> PRA has provided complete clinical development services for many major cardiovascular management staff have cardiovascular experience Key Staff Experienced in Cardiovascular Indications Value-Added Solutions in Cardio-Metabolic DiseasesPRA’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, translating into the ability to rapidly identify suitable sites and suggest members for study committees • Successful patient recruitment, site management, and support strategies • Thorough understanding of the standard of care as well as critical success factors in • Experience in comparatively rare indications such as pulmonary hypertension and acute • Team training materials for monitoring of study specific diagnostic requirements, e.g. echocardiography, ECG, cardiac MRI, SPECT, and diagnostic heart catheterization, as well as disease-specific quality of life measurements • Significant in-house therapeutic expertise in cardio-metabolic drug development Spotlight on Type 2 DiabetesType 2 diabetes mellitus accounts for more than 20% of PRA’s work in cardio-metabolic diseases. We draw upon our proven and current diabetes experience to ensure lessons learned, best practices and operational efficiencies are maximized for our clients’ studies. Many of our Phase I/II studies in type 2 diabetes were performed in our clinical pharmacology units in the Netherlands and United States. We have conducted studies with at least 30 different compounds that were developed for treatment of diabetes type 1 or 2 or metabolic syndrome. Working alongside our clients, PRA is transforming clinical trials through our knowledgeable and skilled staff, innovative approach, sterling execution, and project transparency. Start the transformation now. 4130 ParkLake Avenue • Suite 400 • Raleigh, North Carolina 27612 • USA P +1 919.786.8200 • F +1 919.786.8201 • [email protected]


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ALCOHOL & DRUG QUESTIONNAIRE (Complete all questions) Name of person treated/relationship to applicant: 1. Are you currently using or have you ever used the following substances: Narcotics (heroin, opium, Demerol or their derivatives) Hallucinogens (LSD,PCP,DMT, STP or derivatives) Stimulants (cocaine, crack, amphetamines, antidepressants) Depressants (bromides, barbituates or

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