DATATRAK has expanded the safety components of its single-database, unified eClinical system. The company has added the means for transferring serious adverse event data in a standard format from clinical sites to a centralized safety system.
The Safety Export system capitalizes on the safety data captured by site investigators. By allowing the export of the data, the system eliminates the need for duplicate data entry into a safety system, a process that can slow safety reporting among sites, sponsors and regulatory authorities, the company says. And without data re-entry, safety reports contain fewer errors and contribute to more efficient database reconciliation.
In system supports the International Conference on Harmonization's (ICH) standard E2B file format. In addition, it supports mapping to sponsors' internal standards.
"The Safety Export system is a first step in addressing safety reporting issues," says CTO Chris Wilke. "The next step will be a summer release of Safety System."
- see DATATRAK's release