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PVSentinel SUSAR Distribution

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Establish a Lean, Efficient and Consistent SAE Management process

Clinical Research Organizations (CROs) and Pharmaceutical companies have a regulatory responsibility of distributing SUSAR and other safety documents originated from sites to Ethics Committees, IRBs, others within the mandated timelines. The SUSAR information may be distributed using standard formats such as CIOMS, MedWatch or using custom defined formats based on the specific study needs. The process of handling and distribution of safety documents is currently managed using manual or semi-manual methods leading to reduced process efficiency, lack of clear oversight, increased costs etc.

How PVSentinel SUSAR Distribution Can Help

To facilitate efficient and consistent safety data and adverse event reconciliation, our automation powered solution can enable sponsors to define configurable workflows, schedule jobs, track outcomes and report on quality and compliance measures.

PVSentinel SUSAR Distribution is a purpose-built solution to address the specific functionality, workflow and challenges of managing entire life cycle of safety documents. SUSAR Distribution provides following benefits to the pharmaceutical organization and help streamline various compliance related activities at study sites:

  • Automate full life cycle of safety documents there by enabling higher compliance and superior oversight
  • End to end digital operations provide improved oversight and control on the operations
  • Transparent process minimizes the potential for errors
  • Reduced efforts and reduced costs

Key Product Features

  • Supports various delivery methods such as e-mail, fax, mail etc.to various receivers such as site users, ECs, IRBs etc.
  • Automatic generation of cover letters and assignment of distribution list
  • Configurable rules engine enables defining workflow for end to end life cycle management of document distribution at global and country level
  • Collect and track acknowledgements
  • Integration with multiple source systems such as Drug Safety Database (Oracle Argus, LSMV etc.), CTMS (Oracle CTMS etc.), Content Management Systems (Veeva, Documentum etc.)
  • Audit trail of all activities including for configuration updates and changes
  • Access controlled unblinded information and read receipts management
  • Get alerted and notified on work assignments, expiry and changes
  • Ready to use and extendable dash boards and performance indicators for an effective distribution management and compliance tracking. Share reports in various formats PDF, ppt, through various channels

How Do We Deliver

PVSentinel SUSAR Distribution is a component of our PVSentinel platform. It can be deployed on its own or in combination with other modules of the platform.

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