Reflection Report - P&G Data Capture and Clinical Trial Management

Memorandum

To: Ray D'Alonzo

From: Nikita Patel

Date: June 23,2014

Subject: Re: Reflective Analysis – P&G Data Capture and Clinical Trial Management

 

This memorandum is with regard to the meeting held last Tuesday with the consulting team ‘American “A” Experts’. I believe the consulting team provided some thoughtful insights with regard to implementation of Electronic Data Capture, which can be utilized in arriving at our final decision to solve the three issues we are facing - trial preparation process, data collection & verification and data management & review which will ultimately lead us to a sustainable growth in the health care segment.

After careful analysis of the preparatory notes we had prior to the consultant meeting along with the presentation & data provided by consultants, I see that the consultants discussed most of the benefits of EDC which leads me to consider my initial judgment of moving forward to implement EDC into our system. This is based upon the fact that the virtual world is going to change the future of businesses around the world. P&G should use this opportunity for adapting to new technology and embrace the technical tools available in the market to its capabilities. In addition, the EDC trials were highly successful and proved the system reduces the errors and inaccuracies of human data entry and completely eliminates the double-entry system.  During the trial of the EDC, the duration of time from the final patient visit to data-lock improved from eight weeks to a mere four weeks. There was also an improved quality of patient data, since errors were being corrected throughout the process. 

Also as presented by the consultants in the total weight analysis slide, it proves that of the maximum weighted sum of 123 that can be achieved on the various criterion, the EDC alternative provides a sum total weight of 108 whereas the other 2 alternatives gives a weighted sum of only 81 & 90 on the various criterion. The estimated improvement in the clinical trial phases, particularly in phase 3 shows that the number of years could be considerably reduced from 3.5 to 1.5 which will be a significant achievement for our company compared to other firms operating in the healthcare industry. We could save $ 211,600 per trial as shown in the estimated saving slide which surely is a plus point in considering this decision.  The analysis shows that the savings from CRA monitoring visit itself will be $ 180,000 which is considerable as the CRA can then be involved in other productive work thereby reducing the intake of hiring new employees. It is impressive to see the total savings for P&G if EDC is implemented.

Considering the above facts in reducing the length of time in our clinical trials and achieve cost savings in future, I believe it is worth taking the risk to invest in the implementation of EDC. Improving our current paper-based system is worth discussing in greater detail, while we should rule out the alternative of digital imaging due to the massive investment costs of storage space. EDC seems to be an ideal alternative that addresses the problem and the symptoms we face currently; the other two alternatives seem to address only the symptoms. Once the sites and sponsors are well versed in the EDC system, the entire process will be more efficient and effective.

If you have any further questions, please do not hesitate to contact me.