Safety to Investigator Reporting
A challenge that faces many biopharmaceutical companies when distributing safety reports to investigators and IRBs/IECs is finding the balance between quality, a high level of compliance, cost efficiency and productivity of internal resources.
agNotify is a web-based software solution specifically designed to automate the electronic distribution of safety reports to investigators, IRBs/IECs and any other stakeholders. It supports the complete process of delivering and tracking safety reports whilst reducing costs, freeing valuable resources and helping companies to ensure regulatory compliance. SIR integrates out-of-the-box with ARISg and is capable of linking to CTMS databases.
agNotify is an advanced reporting system that automates the distribution and tracking of clinical safety reports to investigators
Support for the complete process
agNotify supports the complete process of preparing, distributing and tracking safety reports sent to investigators and IRBs/IECs. The very easy to learn web portal gives investigators immediate and easy access to the newest safety information.
Automatic generation of the distribution lists
Automatic generation of cover letters, which can be produced in the native language
Cross study reporting
Secure and fast distribution via web portal, email, fax or postal/courier service according to the investigators preference
Automatic tracking of receipt acknowledgements
Support of individual case safety reports (e.g. SUSARs) and aggregate reports (e.g. line listings)
Receive reports as CIOMS, MedWatch or in any other format required
Easy access for investigators to “their” safety reports using a preferred medium (web portal, email, fax or postal/courier service)
Maintenance of distribution lists
Flexible distribution reports
Integrating out-of-the-box with the leading safety database ARISg
agNotify enables organizations to ensure and proof compliance whilst reducing the costs of distributing SUSARS or other safety information to investigators and other stakeholders. Reduction in workload frees resources in pharmacovigilance and clinical operations for more value adding tasks.
Quick ROI from labor, courier/mailing cost savings
Helps to ensure compliance with international regulations
Helps to keep processes under control
Frees valuable resources for other tasks
Large efficiency gains through automated paperless distribution
Automated receipt acknowledgement tracking largely eliminates manual follow-up with sites
Delivers reports based on investigator preferences
Fast deployment via agOnDemand™ eliminates IT infrastructure and support overheads