Helping organizations move away from reactive Aggregate Safety Reporting

The Challenge

The regulatory demands of guidance, PV Legislation, and local Health Authority requests are ever-increasing. With that, so too is your global Aggregate Safety Reporting workload. The logistical challenge of responsibilities and safety commitments are time-consuming efforts that without consistent management, can be ineffective, costly, and even detrimental to patient safety.


Teams must manage a myriad of tasks in their daily workload, with responsibilities compounding over the high volumes of reports, products, and countries. While many teams have existing systems in place, such as RIMS and Document Management Systems, functionality for tactical report management and oversight is limited.

Mitigating Process Risks

Due to the complexity of processes, lack of centralized systems, and ad-hoc workflows, Safety Teams risk delivering late reports, overlooked commitments, quality errors, and limited visibility of real-time performance.

Lack of Strategy

Because this process involves a multitude of documents, over many functional areas and teams, there is plenty of room for missed deadlines, poor communication– a plethora of tasks, with no central head commanding the process.  Teams are often left reacting to their workload, so they miss opportunities to manage processes in a more proactive way. For example, the document exchange process alone requires steps for approval, identifying recipients, writing instructions, and sending those documents off. The questions of – what are my obligations? what is the timeline? where is the information? who do I contact for notifications? who is assigned? – are all challenges that compound as the organization grows.

Reactive and decentralized report management creates real risk for pharmaceutical organizations, whether that be reduced efficiency, non-compliance, or simply missed opportunities to optimize their reporting processes.

Finding a better way forward

Real-time Collaboration

The need for constant communication among many moving parts is perhaps the most challenging aspect of global safety within your organization. Why wouldn’t you prioritize systems that ensure timely, unified, and efficient execution of tasks and responsibilities? The who, what, and when should be continuously updated and current in sharing key information locally and globally, ensuring productivity, oversight, and compliance. An ideal solution will alleviate the incessant back and forth of who to email, assign, and update, all while allowing for total transparency of activities, timelines, responsibilities, and the like. Orbit’s centralized tracking drives these activities through structured workflows making the global process more manageable. Communication is tailored to appropriate recipients with deadlines, assignments, and individual task requirements sent out in real-time. Health Authority feedback, edits, and all other notifications are centrally managed, offering total transparency end-to-end.

Connecting Systems, Processes, and Workflows

Process gaps between key safety systems are one of the first areas to focus attention. You can “fill the gap” of workflows between RIMS, DMS, and other systems by connecting the periodic reporting schedule from your RIMS system into Orbit for planning. Orbit can manage the authoring process, or link to an existing document management system to improve information continuity across systems. Where there were once gaps in information, Orbit provides oversight of all the aggregate safety reports over time, detailing status, milestones, tasks, communication channels, and hand-offs between teams. Orbit plugs gaps where the delays, miscommunication, and hand-offs occur, allowing access to all the aggregate reports across your product portfolio. The power of harnessing this data optimizes the safety reporting process entirely, alleviating the collection and reporting between global and local teams.

Simplifying the Process

Orbit centralizes the multiple handoffs between the partners, vendors, and marketing countries through tracking, tasking, and overall management of safety reporting. Orbit provides the tracking and oversight capabilities needed to manage the complexities. Here’s a glimpse of the detailed tracking capabilities we provide:

  • GANTT Chart – key dates, project timelines, color coding prioritization
  • Track and notify partners, contributors, and other stakeholders of key activities
  • Link relationships between reports and other records, business partners, and commitments  
  • Safety commitments like Health Authority feedback and other requests
  • Centralizing all the information globally

Orbit is the Solution

Safety reports are the vehicle to regulate dialogue across global and local requirements, increasing productivity and uniformly staying on task. With the more complex and regulated need for accurate and timely safety documents among stakeholders, Orbit’s platform tailors its approach for simpler management and oversight.

Interested in optimizing your daily commitments of distributing, tasking, and monitoring? Contact us for a demo or additional information at