Pharmaceutical Executive Europe - June 2008 - (Page 12) 12 IT Matters June 2008 Pharmaceutical Executive Europe The High Cost of Swimming Upstream George Laszlo explains why we should be careful not to upset the flow of our business processes when implementing ‘mid-stream’ solutions such as EDC. I f you have been to Basel, the home of industry giants Roche and Novartis, you may have crossed the Rhine on a ferry boat powered by the strong currents of that river. Weather permitting, you may have also put on your bright yellow bathing suit and blue bathing cap and plunged into the river to let it gently push you downstream. Either of these wonderful experiences is a great reminder that swimming downstream is a much easier task than going the other way. Yet, when it comes to improving the way we run our companies, we often choose to swim against the current, a strenuous and costly method indeed. In the 1990s, a lot of energy (that is, time, money and work) went into implementing regulatory submission systems so that staff at the FDA and EMEA could perform their reviews in a more efficient and timely manner. Never mind the upheaval this caused ‘upstream’ for the teams responsible for collecting, managing and reporting on the data. Rather than ask how the upstream work got done and how it could be improved, all of the energy went into the publishing process. Yes, the people in Regulatory Affairs and the staff at the regulatory agencies were happier and often praised the efficiencies delivered by these systems. Unfortunately, no-one bothered to measure the true cost of the solution. In the 21st century, we have embarked on a mid-stream journey called electronic data collection (EDC). In this case, the industry chose to focus on the middle piece of the clinical trial process where the collection and clean-up of study data were perceived to be the greatest hurdle to database lock. By eliminating double-data entry and forcing data clean-up at the time of data collection, we have indeed reduced the time it takes to collect all of the data. Unfortunately, we have forgotten to look either upstream or downstream to identify and tackle other problems plaguing the clinical trial process. Looking upstream, equal time should have been given to processes and systems used for trial design, protocol development, site selection and statistical analysis plan creation. Looking downstream, time and effort should also have been allotted to data standardisation and management, statistical analysis, pharmacovigilance, pooled data exploration, vendor management and post-marketing data collection. Some readers will argue that these topics have been or will be given their due. While this may be true, we need to keep in mind another famous adage that “one cannot step into the same river twice.” In other words, when we change one thing in the river, the entire river is affected. So, when we implement electronic publishing or EDC, we affect all other parts of the continuum. company that moves forward with an initiative without doing an environmental impact analysis arising from the endeavour is simply asking for trouble or guaranteeing sub-optimal returns from it. Keeping with our river analogy, the impact analysis must be done both upstream and downstream. More importantly, whenever a new initiative is presented, ask the following simple question: “If we do this, will we be swimming upstream or down?” If the answer is “upstream,” it’s time to set off the alarms. About the Author George Laszlo is the managing director of Laszlo Consulting (US), a firm providing strategic IT consulting to the industry. He is also the editor of The Laszlo Letter, an online webzine devoted to operational excellence in life sciences via IT enablement. http://laszloletter.typepad.com/
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - June 2008 Pharmaceutical Executive Europe - June 2008 Contents From the Editor News and Analysis Calendar Brussels Report - Tell Us Something We Didn’t Know BioFutures - Friends, Acquaintances and Strangers IT Matters - The High Cost of Swimming Upstream Strategy Fundamentals - Hidden in Books Corporate Strategy - New Dimensions for New Business Models Special Report: Making the Leap Sales Force Incentives - The Goal: Setting Goals Last Word Pharmaceutical Executive Europe - June 2008 Pharmaceutical Executive Europe - June 2008 - Pharmaceutical Executive Europe - June 2008 (Page Cover1) Pharmaceutical Executive Europe - June 2008 - Pharmaceutical Executive Europe - June 2008 (Page Cover2) Pharmaceutical Executive Europe - June 2008 - Contents (Page 3) Pharmaceutical Executive Europe - June 2008 - From the Editor (Page 4) Pharmaceutical Executive Europe - June 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - June 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - June 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - June 2008 - Calendar (Page 8) Pharmaceutical Executive Europe - June 2008 - Brussels Report - Tell Us Something We Didn’t Know (Page 9) Pharmaceutical Executive Europe - June 2008 - BioFutures - Friends, Acquaintances and Strangers (Page 10) Pharmaceutical Executive Europe - June 2008 - IT Matters - The High Cost of Swimming Upstream (Page 11) Pharmaceutical Executive Europe - June 2008 - IT Matters - The High Cost of Swimming Upstream (Page 12) Pharmaceutical Executive Europe - June 2008 - Strategy Fundamentals - Hidden in Books (Page 13) Pharmaceutical Executive Europe - June 2008 - Corporate Strategy - New Dimensions for New Business Models (Page 14) Pharmaceutical Executive Europe - June 2008 - Corporate Strategy - New Dimensions for New Business Models (Page 15) Pharmaceutical Executive Europe - June 2008 - Corporate Strategy - New Dimensions for New Business Models (Page 16) Pharmaceutical Executive Europe - June 2008 - Corporate Strategy - New Dimensions for New Business Models (Page 17) Pharmaceutical Executive Europe - June 2008 - Special Report: Making the Leap (Page 18) Pharmaceutical Executive Europe - June 2008 - Special Report: Making the Leap (Page 19) Pharmaceutical Executive Europe - June 2008 - Special Report: Making the Leap (Page 20) Pharmaceutical Executive Europe - June 2008 - Special Report: Making the Leap (Page 21) Pharmaceutical Executive Europe - June 2008 - Sales Force Incentives - The Goal: Setting Goals (Page 22) Pharmaceutical Executive Europe - June 2008 - Sales Force Incentives - The Goal: Setting Goals (Page 23) Pharmaceutical Executive Europe - June 2008 - Sales Force Incentives - The Goal: Setting Goals (Page 24) Pharmaceutical Executive Europe - June 2008 - Last Word (Page 25) Pharmaceutical Executive Europe - June 2008 - Last Word (Page 26) Pharmaceutical Executive Europe - June 2008 - Last Word (Page 27)
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