Future Medical Research Center to launch remote SDV
Lower costs expected to increase clinical trials: hospital EMRs accessible from Tokyo and Osaka
Tokushukai will begin operating a new clinical trial network system, remote SDV (Source Data Verification), on 15 January.
Dedicated rooms at Future Medical Research Center's Tokyo headquarters and Osaka office will provide workstations that can access trial participants' electronic medical records at individual hospitals. The system was made possible with the cooperation of Tokushukai Information System, Inc.
Its main benefit is that trial sponsors, including pharmaceutical companies, can substantially reduce the time and cost required for clinical trials. Tokushukai hopes to attract more trials by highlighting these advantages.
SDV refers to the review of source records by pharmaceutical company monitors. They compare case report forms prepared by trial hospitals with participants' electronic medical records to check that trials are conducted appropriately and that the data is reliable.
Without a network, monitors previously had to visit hospitals in person. Trials at hospitals far from Tokyo or Osaka therefore involved significant travel expenses and time.
Tokushukai operates hospitals nationwide, including many far from Tokyo and Osaka. At the Tokushukai healthcare management strategy seminar on 22 December, Future Medical Research Center President Hiroshi Yamaji explained: “We planned remote SDV to reduce the disadvantages of distance and enhance Tokushukai's value as a group of clinical trial sites.”
Urban hospitals are also expected to benefit, for example from a reduced workload associated with receiving monitors.
Each of the Center's Tokyo and Osaka offices has two remote SDV rooms. Workstations in these rooms connect through dedicated servers at participating hospitals to display electronic medical records.
Access requires identity verification before entry, a room access ID and password, another ID and password for the hospital's server, and a further ID and password to access and view the EMR.
Surveillance cameras are installed in the rooms. These strict security arrangements protect patients' personal information.
Records can only be viewed; no changes can be made. Monitors can nevertheless work at the screen much as they would during a hospital visit.
This large remote SDV network was possible because Tokushukai uses the same EMR system across the Group and is also standardising its clinical trial systems. Dedicated servers have already been installed at 21 hospitals from Hokkaido to Okinawa. Initial operation will cover these 21 hospitals.
About 200 people attended two briefings for pharmaceutical companies, and the response has been positive. Additional remote SDV rooms will be considered if demand is strong.
Source: Tokushukai Newspaper, 14 January 2013, No. 860