Internal Medicine & Immunology

Our experience in immunology spans early-phase development through successful regulatory submission. This solid experience affords us a thorough understanding of the treatment communities and patient populations with many key immunology disorders.

We have conducted 360+ immunology studies in recent years in wide-ranging indications. Our successful record of managing immunology clinical development programs has resulted in the approval of five important drugs for which we provided critical services.

ICON’s Internal Medicine and Immunology division has established therapeutically aligned teams to provide sponsors with guidance and insight from our therapeutic and clinical experts. We assist sponsors with evaluating and understanding the challenges encountered throughout the drug development life cycle and offer world-class strategies and custom solutions to address specific and unique study needs.

We draw upon extensive global nonclinical, clinical, regulatory, and operational expertise to assist clients with successful trial delivery from IND preparation to product approval. Additionally, we leverage many of the industry’s leading medical, regulatory, and commercial experts as well as long-standing relationships with key opinion leaders, research sites, and academic research centres.

ICON’s Internal Medicine & Immunology team has significant expertise in:

• Drug development and strategy consultation
• Clinical development program planning
• Individual study design
• Peri-IND activities / submissions
• Phase I - III study execution
• Global regulatory submissions
• Product commercialisation (valuation market analysis, positioning, launch, etc.)