P&G - A Note to C-Levels

Fellow C-Levels,

Subsequent to American A Experts presentation and advisement concerning our electronic data capture during clinical trial management I offer the following.  I agree with American A Experts opinion that our current data collection system which originates on paper at the investigation site is archaic and inefficient.  Because of our antiquated data collection process we’re missing an opportunity to expedite the delivery of new products to market.  As you are all aware each day of delay in market entry of a new product costs us approximately $1,000,000.00.

To avoid market entry delays we must increase the efficiency of our data capturing process.  It is my recommendation that we implement, as suggested by American A Experts, a web enabled electronic data collection system.  We all know a global roll out of a web based data collection system will come with challenges and will be met with resistance at some investigation sites.  However it is imperative that we implement the web based system globally to avoid operating two independent systems as our internal infrastructure is insufficient to meet the demands of two data collection processes.  My recommendation is supported by the concept of efficiency.  When data is entered electronically at the investigation sites the data collection process is streamlined and we eliminate inefficiencies.  Some of the inefficiency we eliminate include, double entry of data, inaccurate entry of data, delays in data lock due to improper inclusion of candidates and lag time in overall data review process.  Implementation of a web based electronic data collection system will eliminate the items discussed above, expedite the market delivery of new products and have a profound effect on our ROI.  

Investigation site opposition to the conversion will be overcome by providing each site with the necessary hardware to collect the data and proper training and help desk support.  Training will be conducted biweekly for 2 months and monthly for the next 4.  Help desk support will be provided free of charge for the life of the program.  The costs incurred to implement and support the web based electronic data collection system are far outweighed by the cost savings and revenue generation of expediting the market delivery of our new products.

Microsoft Visio & Work Flow Diagrams

Dr. P.,

In accordance with our conversation regarding the implementation of Microsoft Visio I offer the following.  Microsoft Visio is an advanced diagramming tool that helps organizations simplify and graphically render complex business processes.  Our firm could use Visio to generate work flow process charts for our foundation construction projects.  All of our team members understand the work items required to construct a concrete foundation however not all member clearly understand how the work items are related.  We can use Visio to create and share with our project teams work flow diagrams showing the relationships between specific activities associated with foundation construction including, site clearing, building excavation, h-pile installation, concrete pile cap construction, underground utility installation and slab on grade construction.  Visio’s charts will enable project coordinators to identify potential bottlenecks in work flow activities and or opportunities for task synergy.  

Eliminating onsite schedule delays caused by unforeseen bottlenecked activities would minimize lost work hours.  Similarly, incorporating task synergies and working on tasks at the most opportune time will lead to optimum work flow efficiency.  Using Visio to reduce lost time and increase efficiency will have a direct impact on the bottom line costs of our projects.  

Examining our upcoming Grippo project our labor and equipment budget is $300,000.00 and $150,000.00 respectively.  If Visio’s charting capability and related work flow efficiencies generate a savings of 3% the project related construction costs would be reduced by $13,500.00.  Multiple this savings across all of our projects and we’ll experience six figure savings.  Therefore, I recommend we purchase Visio ($95.00 x 2 units = $190.00), train 2 existing project coordinators to use the software (training class 2 x $500.00 = $1,000 + 16 hrs. of training pay x $40 = $640.00) and implement the use of Visio to create project work flow charts for each new foundation construction project.  Total initial investment = $190.00 + $1,000.00 + $640.00 = $1,830.00.  Expected savings on upcoming Grippo project $13,500.00.  Net benefit = $11,670.00

P&G - EDC Challenges

P&G has encountered data collection process inefficiencies that are causing delays and extending the time to data lock.  The problem is the costs associated with the data lock delay which are generated by the delay to deliver a new product to the market.  The symptoms of the problem are redundant data entry using paper based systems, inaccurate reporting using paper based systems, longer approval cycles before roll out using EDC systems and investigator sites unwillingness and inability to use web based EDC systems.   

The scope of the problem consists of three components; trial preparation, data collection and verification and data management and review.  Using EDC trial preparation has not run as efficiently as possible.  Due to inexperience eCRF have taken longer to develop, approve and test than paper based models.  However, with experience eCRF assembly times will decrease and eventually mirror the duration associated with preparing paper CRF’s.  During the data collection and review phase of clinical trials P&G has experienced a costs saving of $3 to $5 per CRF page by switching to electronic data collection forms.  In addition CRA's travel time to investigation sites has been reduced by 50%.  However resistance and challenges have been encountered at investigation sites.  Some investigation sites are unfamiliar with computers in generals.  Others had connectivity issues because of slow internet access.  Other sites refused to use the system.  In addition, some investigator sites experienced extended data entry time because of the instant edit checks performed by the eCDF and corresponding requirement to edit the data to complete the form.  In summary a lead CDM at P&G summed up the implementation of the web based EDC system by saying, “at the investigation sites the EDC system means more work, more trouble and ultimately more stress.  For those reasons some sites may think it’s easier to stay with the paper based system.”  The most successful result of the EDC was the reduction in time to data lock from 8 weeks to 4 weeks during the course of the first few trials.  This decrease in time to data lock could be attributed to improved access to data and more efficient querying.  In addition, the quality of the data increased as eCDF forms required inconsistencies to be edited before allowing the form to be submitted.  CDM and CRA roles have become similar as CDM’s direct interaction with investigation sites has increased while CRA’s had to understand the technology and know how to perform certain EDC functions a task previously performed by CDM's.

The context of the problem revolves around the investigation sites ability to obtain the hardware, understand the software, realize the benefits of using a web based data collection and have the proper internet connectivity to use the system.  Decision criteria:  Can we provide the investigation site with the required hardware?  What will the costs and benefits be if we provide the hardware?  Should we provide training on the use of the e-based data collection system?  How can we overcome internet connectivity issues? Should we look to use the EDC system in specific locations where connectivity is not an issue?  Can we partner with an ISP provider to bring internet to problem areas?

What are the alternative courses of action? 
1. Keep the paper based system. 
2. Develop a hybrid paper based and electronic data collection system and roll out the system according to each investigation sites ability and wiliness to use the system. 
3. Complete conversion to an electronic data collection system.

Keeping the paper based system does not address the key problem of reducing the time to lock the data as the inefficiencies of the paper based system created the problem. A hybrid system would address the time to data lock in some clinical studies however the studies which remained on the paper based system would still be an issue.Complete conversion to an EDC system would address the time to lock problem but global incorporation is complicated by the inability of some investigations sites to use electronic based data collection systems.

The decision criteria should be evaluated by the ability to implement the appropriate decision to address the key problem of reducing the time it takes to lock the data and weigh the costs and benefits of implementing the solution.  The evaluation can be imaginative however the decision must be viable.

My recommendation is to globally implement an electronic data collection system.  The challenges presented by the investigation sites can be overcome by providing the sites with the necessary hardware and offering software training and support.  Sites that have internet connectivity issues should be excluded from the pool of potential investigation sites until connectivity issues are resolved.  As an alternate project we could look into partnering with an ISP’s to deliver internet to sites that lack connectivity.  The per page cost reduction of eCDF, reduction in CRA’s travel time and decrease in time to data lock offered by the implementation of EDC makes global implementation the quality recommendation.

Ubuntu's Compatibility Issues

Dr. P.,

In accordance with our conversation regarding the adoption and implementation of Ubuntu I offer the following.  Ubuntu has become a viable competitor to our current Windows operating system.  Our firm owns 45 computers all of which are running on Windows and include the desktop applications offered by Microsoft Office.  Our current IT maintenance contract requires the replacement of 15 computers annually.  The cost for Microsoft Office and Windows are $185.00 and $99.00 respectively.  Each year we spend $4,260.00 (15 x $284.00) to purchase Windows and Microsoft Office.  Ubuntu is free and comes preloaded with LibreOffice a software bundle that offers applications which are very similar to Microsoft Office.  Ubuntu’s spreadsheet program and word processor are easy to use and closely resemble the current Microsoft applications we use.  Should we decide to switch to Ubuntu the similarities to Microsoft Office and ease of use would minimize the impact to our employee’s current productivity levels. The apparent cost benefit of switching to Ubuntu is $12,780.00 (45 computers x $284.00)

However, the cost savings noted above are offset by Ubuntu’s incompatibility with our current financial and project estimation software.  EarthWorks, our project estimation software, has been used by our estimating team for 15 years and is linked to our financial software such that the financial software uploads historical cost data into our estimating program perpetually refining our historical cost database.  Since 1999 we’ve invested $80,000.00 to purchase EarthWorks which includes the cost of additional user licenses and software upgrades.  In addition, we’ve spent $50,000.00 on training.  Our total EarthWorks investment of $130,000.00 has enabled our staff to generate estimates quickly and accurately as evidenced by our estimate to job conversion factor of 17%, which is 7% higher than the industry average of 10%.  By switching to Ubuntu we would realize a cost savings of $12,780.00 and loose our ability to utilize programs such as EarthWorks that are critical to the daily operation and sales of our organization.  The numbers speak for themselves we cannot afford to compromise the operation of our enterprise estimating software which generates eighty million dollars in annual sales to reduce our annual IT costs by $4,260.00.

Construction Industry Blogs

Dr. P.,

In accordance with our conversation regarding the use of blogs as an IT tool for our business I offer the following.  Blogs have long been known as a vehicle for voicing the vibe or pulse of an organization.  Many corporate blogs are presented incorrectly as they are used, typically, much too obviously, as marketing devices.  Even cleverly written blog such as a blog used by Zillow, which creatively informs buyers of financing options for their next home purchase, ultimately directs potential buyers to Zillow’s Mortgage Marketplace.  Such a blog is certainly informative however any mortgage broker would provide their clients with the same information.  The blog doesn’t generate adequate levels of business to justify existence.

Implementing the use of blogs for marketing at our firm would be a fruitless endeavor.  Valuable time would be spent by our marketing department writing and posting blogs that would not lead to top or bottom line growth.  The costs incurred to create the blog would not be offset by revenue generation as 85% of our construction business comes from repeat clientele, 12% from referrals and 3% from website inquires.  A better allocation of resources would be spent increasing and updating our website content.  Therefore I recommend we pass on implementing the use of blogs in our firm and focus our marketing resources on further developing our website and strengthening our relationships with existing customers through the use of company sponsored events.