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PRA streamlines clinical data management

By Kirsty Barnes , 06-Jul-2006

PRA International has been busy implementing an advanced data management system as part of a number of new internal measures aimed at improving operating efficiency and cutting the costs of clinical trials.

Developed by DataLabs Clinical using Microsoft software, the Flex DMS can be used for electronic data capture (EDC), but can also be used to convert paper data entry into an electronic format.

The new solution allows users to design a clinical study once; collect the data either through paper data entry (PDE), EDC or a combination of formats; and then clean and manage the data using the same system and virtually the same process.

 

While EDC is rapidly gaining acceptance among the medical investigator community, paper reporting is still the dominant data collection method used so there is still a real need to manage paper reporting in clinical trials as efficiently as possible.

 

"We are expecting the Flex DMS to produce savings in the time and costs involved with running clinical trials although at this stage it is too early to quantify these savings," company spokesperson, John Lewis told Outsourcing-Pharma.com.

 

Since April PRA has been rolling out the Flex DMS to its clients on a gradual basis and currently has 20 clinical trials that are in various stages of development using technology.

 

"From now on though it will be used by all of our clients globally, but to what degree it is used for EDC will vary and is dependant largely on the investigators using the system," said Lewis.

 

"Although trial sponsors can try to encourage the use of EDC, many clinicians are still not comfortable using computers and many investigator sites throughout the world are not adequately set up for EDC yet either."

 

Earlier this year PRA saw its first quarter profits tumble on the back of a major contract loss, coupled with ongoing delays in its biotech contracts, and the company has been introducing several new project efficiency measures, of which Flex DMS is one, as well as focusing on increasing its international presence in order improve its financial performance.

 

So far the move seems to be paying off - PRA's Flex DMS was last week awarded Microsoft's Pharmaceutical and Life Science Technology Innovation Award in the Clinical Development category.

 

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