Services Case Study

Orphan Drug Designation

Orphan Drug Designation 558 344 Exploristics
Case Study: Generating a statistical evidence package to support orphan drug designation


The Challenge

Idiopathic Pulmonary Fibrosis (IPF) is a debilitating condition in which breathing becomes increasingly difficult due to chronic lung scarring (Figure1). A privately held biotechnology company

Early Phase Oncology Trial

Early Phase Oncology Trial 558 344 Exploristics
Case Study: Biostatistics Support for an Early Phase Oncology Clinical Trial


The Challenge

A small privately owned immuno-oncology company had multiple development programmes in advanced melanoma and advanced pancreatic cancer. These involved the development of an investigational immunotherapy intended

Early Phase RSV Study

Early Phase RSV Study 558 344 Exploristics
Case Study: Generating robust clinical evidence for an RSV development programme using Early Phase Services.


Over 90% of treatments undergoing trials currently fail to reach the market. Effective study planning and analysis is essential to reduce these failure rates …