After our presentation last week to the senior management team at P&G they raised some interesting points and valid issues as far as the implementation of web enabled EDC. After taking their concerns into consideration I still believe that implementation of the web enabled EDC is the way to go if they plan on growing their health care business.
A main concern, of course, is the cost of implementation. There is a significant upfront investment with the software itself, hardware needed at certain investigator sites, and different levels of training needed as well, however I think this cost will be repaid time and time again. Once EDC is in use you can save about $300,000 per clinical trial by not dealing with as many issues as you would have with the paper based method. Not to mention the increased revenue you would make by getting a new drug to market over 30% faster than you would have with the paper based method.
Another serious concern was the effect this would have on investigator sites and employees as far as ease of use compared to the paper based method. People might be hesitant at first to the change, but the software itself is very easy to use and mimics many other web enable programs. Since the use of computers, both personally and professionally, and the internet is so widely spread at this point I think overall training costs and issues will be kept to a minimum.
Where P&G is currently, I think they need to get complete buy in from the organization, especially senior management and than put a team together to work through the SOPs and evaluate vendors based on their needs. They have the option to either rent or buy the software, but that decision can only be made once the team puts together a more in depth requirements list from what was presented and vendors are evaluated equally on these criteria.
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