PharmaManufacturing Benchmarking Survey
Poor Data Management Inflates Drug Development Costs, A New Survey Finds
The average drug development specialist spends five hours a week just looking for data, a new survey finds. All too often, that information is never found, triggering repeats of costly tests and procedures. A benchmarking survey published in the November/December, 2005 issue of Pharmaceutical Manufacturing magazine suggests that fundamental change is needed in the way that pharmaceutical companies handle drug development data. It also indicates a drastic need to improve overall IT infrastructures and work processes in order to help reduce drug development costs.
Most drug companies still store drug development data in separate silos, the survey finds. They also manage their data inconsistently and in an unstructured manner that results in waste and rework, leaves them vulnerable to greater regulatory scrutiny, prolongs development timeframes and increases costs. In addition, the survey suggests, most drug development professionals are dissatisfied with their IT systems and frustrated by what they can, and cannot, do.
Among the survey's findings:
- Nearly 25% of respondents could not trace drug development data back at all, and no respondents indicated that full traceability was even possible. Data traceability and visibility were issues for both large and small companies.
Fewer than 5% of respondents use structured databases to store drug development data.
- Drug development professionals spend, on average, five hours per week looking for data. Some respondents spend eight hours or more on data retrieval each week.
- Roughly two-thirds of respondents could not find the data they needed between 10 to 20% of the time, triggering rework and duplication of tests and procedures.
Designed to shed light on current practices and to help drug manufacturers benchmark and improve their data management practices, the survey was developed and interpreted for Pharmaceutical Manufacturing magazine by Dr. Ken Morris, Purdue University's Associate Head of Industrial and Physical Pharmacy, as a consultant
to Conformia Software, Inc. Conformia is currently working with FDA on a cooperative research and development agreement (CRADA) to determine the root causes of drug development bottlenecks. Coauthoring the survey and summarizing its results with Dr. Morris were Sam Venugopal, Director, and Michael Eckstut, Vice President of Conformia's Life Science Business Operations.
Summary benchmark survey results »
Benchmark survey questionnaire »
Benchmark survey press release »
PharmaManufacturing article »
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