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PPD claims new software will expedite clinical data review

By Kirsty Barnes , 31-Aug-2006

PPD International has launched a new software system that it claims can speed up the review time of safety and endpoint-driven data from large-scale clinical trials or registries.

The software is particularly useful for expediting independent board review of large-scale safety trial data, said the firm.

The GlobalView EventNet is an event management and adjudication system that has been built on PPD's current electronic data capture (EDC) technology and provides access to safety events contained within clinical and/or safety databases.

PPD said the advantage of the new system is that it provides access through an online interface to near real-time data and source documents, enabling the information to be reviewed at any time in any global location.

"The secure Internet, network-based system accelerates review of data, particularly when studies with multiple sources of information on individual patients require review by a board of independent physicians," said a company statement.

"The system can also accommodate multiple event adjudication boards within the same study," said Susan Atkinson, vice president of biostatistics and data management for PPD.

Through an online interface, review board members can request follow-up information or confirm adjudicated events.

The system electronically compares the results of each board member's decision and appropriately documents decisions according to established guidelines.

Other features of the technology include online tracking of safety events, status reporting for activities and e-mail alerts to prompt and encourage timely review.

"In addition, the GlobalView EventNet can be customised to work with clients' data management systems," said Atkinson.

"When coupled with our EDC and pharmacovigilance software, the technology enables us to streamline and expedite this critical component of the drug or device development process."

The use of eClinical software in clinical trials is rapidly gaining in popularity with pharmaceutical, biotechnology and contract research organisations (CROs) as they strive to increase efficiencies in data capture, management and analysis and dramatically speed up this predominantly manual and cumbersome aspect of clinical trials.

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