P&G reflection

As a follow-up to the presentation from consulting team, I think that the alternative, the Web enabled EDC will assist the most with main problem – time to data lock for drug trials.  Looking at two other alternatives (enhancements to the paper based model and digital imaging), are not substantial enough to really cut down on the time to data lock.  These methods while not significantly cutting time also come with added costs; express shipping for paper based enhancements and significant data storage costs for digital imaging. 

I would recommend that P&G should implement the EDC to improve their trial process. By implementing EDC, the data would be entered to the data management system directly by the investigative sites. As I mentioned in the analysis, the biggest advantage of having data captured electronically can benefit the clinical programmers that do hard coding to generate the reports that are finally submitted to FDA. The data can be dynamically updated i.e. for every small changes encountered during the trial process, the programmers will not have to change the coding, rather the change in the captured data will automatically get updated in the final analysis datasets generated. The EDC would require fewer visits from the sponsors to the sites, hence, providing a cost savings and time saving to P&G. 

Also taking into consideration the issue regarding the resistance at the site, I can recommend of developing or coming up with the updates with EDC that has a wizard format that makes it easy for any physician to select a value rather than typing or coming up with the binary number entry format which is priorly coded for particular values like 1 for Male 0 for female in case of gender. Adopting such data entry techniques helps reducing the time and helps overcome the resistance from the physicians’ side. It may take a longer period of time to adapt to the EDC given potential resistance to change, but in the long run, I would recommend that P&G implement the EDC as it will provide a wider range of benefits which will address the issue at hand which is the need to reduce the length of time it takes to data lock.