The New Face oF cliNical DaTa MaNageMeNT
T hE NE w F A c E oF c l iNic a l D aTa M a N a ge Me N T
By andrew Schafer, Senior Director, Strategic Resourcing, Quintiles global Data Management & Biostatistics in today's biopharmaceutical industry, the rapid collection of high quality clinical trial data isn't dependent on technology or software applications, nor is it dependent on process or process reengineering, nor is it dependent on financial business models. Rather, it is dependent on people. Ultimately, people are responsible for turning data into meaningful information, which is what the biopharmaceutical industry needs to be successful. we need information to create better compounds, to design better protocols and to make faster go/no-go/alter assessments on compounds in development. what the biopharmaceutical industry does not lack is data. with very little effort, one is able to quantify how many prescriptions have been filled for a particular drug, or how many oncology products are in Phase iii, or what the average query rate is for cardiovascular compounds in Phase ii. This is nothing new, so what has changed that makes people so important
L IF E B E Y ON D T R A DI T ION A L D A T A M A N A G E ME N T
Electronic Medical Records Increasingly, the industry is turning its attention to the use of electronic medical records (EMRs) for clinical development purposes. The use of this technology, and the data held within these systems, is a prime example of how clinical data management is morphing from straight data collection into being an information provider.
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T he Ne w Fac e oF c liNic al DaTa MaNageMe N T
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The data held within EMRs can help clinical development in a number of ways, but the path to value will not be short or easily traveled and will require investments in capital, human resources and time. Protocol writers can use EMRs to perform feasibility analysis; biostatisticians can use them to do scenario planning; and clinical operations can use EMRs to find clinical investigators and patients. Ultimately, it will be up to the data managers to manage, access and control the data that has so many potential benefits across an entire clinical development program. Adaptive Clinical Trials The increase in the sheer volume of data is one challenge facing data managers; another is the speed at which quality data is collected. As adaptive clinical trials become more commonplace, speed of data collection becomes the driving force of value. For adaptive designs to truly provide value, data needs to be collected quickly and delivered into the

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