Endocrine & Metabolic

Challenges for Conducting Endocrine and Metabolic Studies in Clinical Research

Metabolic studies can be challenging in terms of patient recruitment and study efficiency.  Metabolic studies demand rigorous attention to regulatory strategies and safety data.

Key Requirements for Metabolic Development Programs

• Proactively identify and avoid potential challenges for these often novel therapies
• Design smart, efficient trials that are both cost-effective and address regulatory requirements for patient safety
• Develop more accurate feasibility assessments and accelerate patient recruitment
• Adjudicate clinical events or endpoints rapidly and efficiently

With a successful track record of approvable NDA submissions, deep therapeutic expertise and more than 20 years of experience, Medpace successfully navigates the complexities and regulatory scrutiny of endocrine/metabolic development programs.

Deep and Broad Endocrine/Metabolic Experience

• Since 1992, Medpace has conducted hundreds of endocrine/metabolic trials around the globe
• Significant involvement in 20 NDA submissions
• Large-scale multinational trial programs, including in emerging markets
• Broad compound experience for Type 1 and Type 2 diabetes, NASH, major obesity programs, hypercholesterolemia, mixed dyslipidemia, and/or with very high triglycerides

Experience in Difficult to Recruit Populations

• Narrow HbA1c criteria
• Concomitant diseases (obesity, hypertension, metabolic disorders)
• Metformin-only patients