Updated on 6 September 2012
As firms face the danger of non-compliance and can even place the status of their development and commercialization efforts in jeopardy from late or incorrect regulatory filings, many developers choose to place strict controls on all pharmacovigilance operations and mandate in-house capabilities whenever possible.
A mandate for quality
Yet, within the overall landscape of regulatory changes, clinical trial management and technology solutions, opportunities to develop more strategic pharmacovigilance processes exist. Today, many multinational pharma companies have developed partnerships with clinical research organizations (CROs) within Asia to help develop and manage pharmacovigilance operations and strategies.
Further, the use of both outsourcing and offshoring across a wide range of clinical trial activities beyond pharmacovigilance has grown considerably in recent years for both domestic and global developers. More promisingly, hurdles to processing documents and data across language barriers are falling, as an increasingly talented workforce and advanced expertise are being developed at a rapid pace across Asia.
For firms that place a premium on both quality and productivity, finding a CRO to serve as a strategic partner can be difficult. For many developers, the bulk of work currently being outsourced to outside providers is centered primarily or exclusively around lower-level data entry and site management tasks. For maximum success, however, a pharmacovigilance services provider must be able to successfully manage complex data collection processes inherent in large studies involving multiple non-clinical sites, possess a deep understanding of regional regulatory requirements and offer the highest possible levels of data management quality and language capabilities.