The primary purpose of sending safety reports to investigators is to provide investigators with information they need to protect their patients participating in clinical trials. As such, the regulatory agencies have mandated that investigators are informed on a regular basis via aggregate reports while immediate notification is required for fatal and life-threatening cases. For many life sciences companies, the distribution of safety reports to investigators and IRBs/ECs can be a labor-intensive and costly process that still relies on a manual process and often expensive courier services. The problem is compounded as new sites are added and sites complete or dropout. Ultimately, these find it difficult to ensure regulatory compliance and impose this administrative burden on highly qualified resources.
LifeSphere SUSAR Reporting™
LifeSphere SUSAR Reporting is the solution specifically designed to automate the electronic distribution of clinical safety reports (SUSARS) and aggregate reports to investigators, IRBs/IECs and other stakeholders with a high level of security and reliability. Using LifeSphere SUSAR Reporting, distribution is instantaneous with cases distributed in the required format (CIOMS/Medwatch etc.,) via the portal, email or fax depending on investigator preferences. With automated acknowledgement handling, LifeSphere SUSAR Reporting ensures compliance and frees resources for more value-adding work. Fully integrated with ARISg for automated report distribution, LifeSphere SUSAR Reporting also allows the manual uploading and distribution of reports.
The LifeSphere SUSAR Reporting sponsor module enables the study team to prepare and review the distribution list, add cover letters and distribute reports based on a specific study or product/compound. Cover letters are generated automatically, with different templates available for the country and investigator. When a report is distributed, the investigator is notified via email that a new safety report is available and a tracking list is created for monitoring receipt.
In the investigator portal, the investigator can access distributed reports with a single mouse click, which in turn generates the acknowledgement of receipt within the system which is immediately available in the sponsor module. An automated reminder function helps ensure the investigator does not forget to read the report. For investigators that do not have reliable access to the Internet, fax or email-based distribution is supported, including automatic tracking of successful or failed fax transmissions.
LifeSphere SUSAR Reporting is a hosted, Cloud-based solution that can be quickly deployed out of the box solution or configured and integrated with other systems, such as any clinical trial management and pharmacovigilance system.