Implementing an electronic safety data transfer system will eliminate inefficiencies inherent with paper-based reporting. Furthermore, the patient safety data exported by the system is already inputted by site staff, ensuring the system does not add to the workload.
The system allows for information about serious adverse events (SAE) and related data to be transferred, using the industry standard E2B format or the sponsor’s internal standards, from clinical sites to centralised safety reporting systems.
Datatrak will further strengthen its eClinical safety package in the summer when it launches its Safety System. Speaking to Outsourcing-Pharma, Lisa Pahl, director of product management at Datatrak, explained that this is a safety case management system for tracking and reporting data.
“The system allows safety data to be tracked and reported on as well as monitored across trials for a single sponsor”, explained Pahl. She added: “The Safety Export is the first step in data exchange between the eClinical product and the Safety System.”
Focus on safety
Datatrak is making these improvements to its safety offering having identified it as the next area of focus based on market growth and client demand. Pahl said that clients have requested this functionality and consequently Datatrak expects it to be implemented in new and existing studies.
The product is currently in final packaging, added Pahl, and Datatrak is working on a roll out plan with current clients.
Furthermore, extending the product to include Safety Export lays the foundation to implement data reconciliation, added Pahl. This forms part of Datatrak’s efforts to provide end-to-end solutions spanning the entire clinical trial process, referred to by the company as the “S-curve”.