ARTICLE | Product Development
IntraBiotics blames the software
January 22, 2001 8:00 AM UTC
As if biotech and pharma companies don't have enough to worry about in outsourcing their clinical programs, such as making sure their trial protocols are closely followed, IntraBiotics Pharmaceuticals Inc. last week blamed a "freak event" for disrupting two of its Phase III trials.
IBPI maintains that no amount of auditing could have detected a computer programming error by a subcontractor that resulted in Phase III patients receiving both placebo and its Protegrin IB-367 synthetic antimicrobial peptide analog rinse to treat ulcerative oral mucositis in chemotherapy and radiotherapy patients...