Case Studies

EXPERTLY MANAGING ACCESS REGULATORY COMPLEXITIES THROUGHOUT A DRUG’S DEVELOPMENT LIFECYCLE

Therapeutic Area: Rare Debilitating Disease Clinical Trial Phase: Phase 3

HELPING A SPONSOR COLLECT DATA IN AN EXPANDED ACCESS PROGRAM TO SUPPORT CLINICAL TRIAL DATA

Therapeutic Area: Oncology Clinical Trial Phase: Phase 2

HOW STRONG PROJECT MANAGEMENT DELIVERED A SUCCESSFUL CELL THERAPY EAP

Therapeutic Area: Cell therapy Clinical Trial Phase: Phase 2

HELPING A SPONSOR PROVIDE ACCESS TO INVESTIGATIONAL DRUG OUTSIDE OF CLINICAL TRIAL

Condition: Rare, progressive autoimmune condition Clinical Trial Phase: Completed Phase 3

USING EXPANDED ACCESS AS AN ALTERNATIVE TO AN OPEN LABEL EXTENSION (OLE) STUDY

Condition: Rare Gastrointestinal Tumors Clinical Trial Phase: Phase 2

HELPING A SPONSOR RESCUE AN EXISTING EAP FROM ANOTHER VENDOR

Condition: Debilitating neurological disorder Clinical Trial Phase: Completed Phase 3