The issues that can stem from weak or incoherent cyber protection include:
PATIENT DATA LEAKS
Pharmaceutical companies are gradually moving towards becoming more patient-centric. They store information about individual customers to serve them in a more personalized way. A Cambridge-based biotech company offers a good example of deploying a more patient-centric approach towards drug formulation. The biotech company had collaborated with Parent Project Muscular Dystrophy (PPMD), an advocacy group, and had used the latter’s patient preference study to get faster approval for the first disease-modifying therapy for the Duchenne Muscular Dystrophy. A compromise in the confidential data can be dangerous for the customer. Moreover, a data leak will end up having legal ramifications for a pharmaceutical company. The pharma company must, therefore, be extra careful with this data to maintain consumer relationships and avoid litigation.
PHARMACOVIGILANCE AUDIT ISSUES
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