The Process and Tracking “It” in Orbit

A Year in Orbit:  Summit 2022 Recap

This year we concluded our Annual Orbit Summit by highlighting this past year and what to look forward to in the future. As our tenth year in the drug safety space, we’ve grown not just in technology but across the entire company, expanding both our offerings and our team. Initially cutting our teeth as a tracking solution  for Risk Management, the Orbit Platform is now recognized as the industry standard for tracking and oversight with Aggregate Safety Reports, Pharmacovigilance Agreements, Signal Management, and more. Our modular, inter-connected platform is now more refined, growing with you as you and the entire industry continue to drive the requirements and demands for supporting technologies. 

Since demonstrating our Feith Core Technology in 2012, we continue to grow and answer those needs that customers, like you, have requested in a solution. Throughout the decade our mission hasn’t wavered. Our mission has always been to provide GxP validated software for all of your PV-related needs, helping you mitigate risk and enhance visibility overall within patient safety. More than just another tracking platform, we  go beyond tracking the “thing” by automating the tracking of the process with which those “things” are associated. Whatever the process and “thing” may be, our solutions are purposefully designed to be adaptive with the ever-changing regulatory landscape, and to work synergistically with other systems both now and in the future.

Post-Pandemic World, the Business Processes Are Here to Stay

Kevin Fetterman, our Executive Director of Client Engagement, opened with the process and operations companies and health authorities have learned to adopt on the fly since the pandemic. For instance, local authorities are interested in knowing more about what other countries are doing, the coordination of global to local, and then local back up to global requires seamless hand-offs with materials, tasks, and back and forth communications; driving the need for a platform that provides all of that visibility into your safety processes. Ten years and counting, Orbit provides a holistic visibility across your PV commitments and puts your data to work for you in order to provide a clear view of the what, when, and how of all of your related pharmacovigilance needs. As Kevin stated, “Good trackers can help you track the ‘thing’, but great trackers can help you manage the process, and that is the Orbit difference.”

Latest and Greatest 

We continue to advance our capabilities across our core competencies plus creating new solutions to keep up with the safety demands in the years to come. For example, in:

  1. Safety Reporting — we have expanded upon scheduling, connecting reporting dates from other systems and automatically kicking off those workflows from those systems,
  2. Signal Tracking — our module now integrates internally with other trackers, allowing for greater visibility in the planning, detecting, and tracking,
  3. PV Agreement (Business Partner) Module — helps manage the development of the agreements plus driving forward all the associated commitments and timelines for the agreement once it is active,
  4. E-mail Integration — allows you to dynamically track and manage your communications, especially with the volumes and storage limitations in Outlook or other e-mail applications.

Our growth goes beyond our technology. You, our partners, and customers have contributed immensely to this growth. Our diverse representation across the industry from top 25 pharma to generics and ultra-rare diseases lends to an increasing shared knowledge in the industry that pushes us to build and be that central point for combining that shared knowledge. The numbers speak for themselves:

  •          1 centralized platform
  •          10 years
  •          150+ countries around the world
  •           8+ modules within   the platform + overlaying tools on top of that
  •          15,000 unique trackers within the system across all our customers
  •           27,000 activities
  •           64,000 milestones now actively used in the system

These numbers are a testament of the work we’ve done together, and we are just getting started!

Growth Beyond the Technology

From our start in Risk Management, we are continuously looking to improve upon this core competency. We doubled our implementations this year, with 5 of our 8 implementations in the top 25 of pharma. Being widely used across the top 20% of the market, we can bring new ideas together and continue to grow this implementation based upon your feedback. For example, we took aRMM Trackers and created a DCHP Tracker from regulatory requirements, allowing for a completely different group of people, regulatory, to track and distribute metrics, by using the structure and workflow of the aRMM Tracker. From that same implementation, came a Global Tracker, which is used to track biosimilar products at the global and local level. Our latest tracker, Quality Review, can initiate a quality review from any of the other trackers, tracking the lifecycles of that review of any of the documentations or trackers inside the Risk Management family. Of all the additions, perhaps the most exciting is our work with Merck KGaA on Product Oversight. This solution is a culmination of several trackers, joining all the relationships and links inside the system to build a schedule that captures the big picture of what is going on with a product from beginning to end.

These additional implementations and functionalities have come from you, the industry. As a SaaS Solution bettering and improving upon its core capabilities, we now have these offerings for all of you. Our solutions are improving with the ever-changing regulatory landscape. The more people we have on our solutions, the more we learn about new processes to improve upon; ultimately improving your performance overall.

The End in Mind

Implementation Manager, Chris Long laid out lessons learned with early steps to a successful implementation. Of the best practices outlined, the most important is in having a clear understanding of your needs with “the end in mind.” As we heard in our customer segment, the project needs to be a flexible, step-wise approach, as new timelines and regulations can be introduced. Of the two phased approaches, big bang or a step-by-step approach, Merck KGaA started with our Reconciliation Tracker and built up their processes incrementally with Aggregate (Periodic) Safety Reporting, Doc Exchange, Signal Management and so on. The process was simple, Merck would ask for functionalities and our approach was simpler yet, address and prioritize what is feasible and essential, versus what is nice-to-have.

It is a mindset change, helping you re-think your process in a way that reduces your manual workload to optimize the work you do in and outside of Orbit. We have found that the best way to get the most out of Orbit is by starting small, achieving those immediate requirements, and then circling back to then expand and improve upon that process. Each Orbit implementation is successful with a realistic set of goals and a clear understanding of who those end-users are. For example, notifications or e-mail reminders for tasks due keeps users on track, directing them access to that data easily. By guiding users on what to work on, where to work on it and when it is due, the system serves its purpose as a tool and not a burden.

Going Beyond the Tracking

As our application touches more systems, more people, and more processes, we broaden our footprint with a community that is constantly driving new features and functionalities, bringing new feedback across the portfolio of the system. Matt Rost, Executive Director of Orbit Operations detailed, there can be many reasons for implementing and upgrading Orbit, but perhaps the most important is baked into your processes and needs. We don’t expect customers to be experts in the versioning and functionality within Orbit, our implementation team does that for you. We take the time to understand your functionality, what’s happening, what you need to be able to do, and how to best solve those problems that you want to incorporate inside of Orbit. Our best practice is in understanding your process. We want to be your single source of truth, giving you the best-in-class tracking, tasking, and oversight in real time. Our initiatives are and continue to be centered around making Orbit work for you. Let’s continue to go beyond the “tracking it” in Orbit.

Reach out to us at more-info@workinorbit.com if you’re interested in a demo or would like access to the Summit recordings. Check out our website at workinorbit.com to learn more about our latest capabilities and how to track “it” in Orbit. 

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