January 7, 2014
China Suspends Imports of HIV-Drug on Regulatory Doc Glitch

China Suspends Imports of HIV-Drug on Regulatory Doc Glitch

Some of you might be asking, “Why do I need a collaboration tool that streamlines the regulatory document completion process? Is it really that important?”  On Dec. 31st, there was a short article published in BioSpace that shines a spotlight on the very reason why eliminating paper-based regulatory documents in clinical trials makes sense. According to the BioSpace article, it appears that the Chinese FDA (CFDA) halted shipments of an HIV therapy to China because of a lost regulatory document.  I can only imagine the internal conversations that occurred at Pfizer as a result of losing track of a supplemental application document.  After all, delayed shipments means that life-saving therapies don’t reach critical patients and significant revenue losses can be incurred.     A collaborative cloud-based regulatory content management solution could easily have provided both document visibility as well as expedited completion of the supplemental application. I wouldn’t want to be the executive thinking, “If only I could have used a collaborative cloud network for document tracking, completion and sharing instead of paper.”  This is just one more factual reason to justify your investment in a cloud-based clinical trial content management solution.  It’s also further proof that while using paper often seems adequate, in today’s global drug development environment, taking a legacy paper-based approach to meeting compliance regulations can result in costly delays in drug approvals and shipments.