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.agXchangeSir1

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