Metabolic & Cardiovascular

The increasing prevalence of obesity and its known causative relationship with serious and debilitating disease states (e.g., Type II diabetes, metabolic syndromes, cardiovascular and osteoarthritic diseases) represents a serious and growing healthcare concern. Further, with a continued intense research focus in this area, the link between obesity, metabolic, cardiovascular, and resultant osteoarthritic disease is becoming more apparent than ever before.

As a result of these widespread medical conditions, pharmaceutical and biotech organizations are intensively engaged in developing new therapeutic entities to treat these serious chronic conditions, and importantly, CRMG has been a trusted partner in these efforts since the company was founded.

Led by our drug development experts Stephen Cincotta and Dr. Richard Paul, CRMG brings a team of highly experienced clinical operations and medical professionals that has assisted organizations in successfully developing many novel, safe and effective compounds to treat these indications, including first-in-class products that have received regulatory authority approval. With expertise in both the design and execution of Phase I-IV diabetes and metabolic studies, as well as experience in formulating thoughtful and effective regulatory strategies that includes preparing and representing clients at key regulatory meetings, CRMG is the ideal partner for sponsors looking to move their metabolic compounds into and through the development and marketing registration cycles quickly and efficiently.

As an example of our work in this area, CRMG successfully assisted a biotech organization in bringing a first-in-class therapy to market for Type II diabetes. Please see the related case study in how we helped our sponsor overcome challenging enrollment obstacles to achieve their clinical endpoint in a critical Phase III program that included assessing the compound's cardiovascular risk.

Experience

CRMG has extensive experience in designing and conducting clinical trials in diabetes and associated metabolic diseases. With global experience that spans both adult and pediatric populations, we have conducted trials in recent years in the following: 

METABOLIC DRUGS

• Type I diabetes
• Type II diabetes
• Obesity
• Diabetic gastroparesis
• Diabetic nephropathy
• Diabetic ulcers

Cardiovascular DRUGS

• Critical limb ischemia
• Myocardial ischemia
• Peripheral vascular disease
• Severe heart failure
• Severe intermittent claudication