Pharmaceutical companies encounter challenges with tracking and sharing CORE, EU, and Local implementation of their Risk Management Plans (RMPs). Orbit makes tracking RMPs easy, while improving the planning, and sharing of all Core, EU, and Local RMP positions and related activities.
There are five key challenges when tracking local initiatives. Here’s how Orbit resolves them:
1. Accessing RMPs across all markets:
It can be arduous to survey RMPs across all markets when there isn’t a centralized repository. With legacy processes, data is scattered around the enterprise and between data repositories, which causes difficulty when attempting to keep up with RMPs and tracking RMP CORE positions over time. Orbit’s single validated system provides global teams with clear oversight into their local commitments.
This centralization means that when it comes time for inspection, pharmaceutical companies will have the information they need readily available. Time is not just money, but for RMPs, time can also be a risk. A risk to consumers, and a risk to the company.
deviations from CORE:
Pharmaceutical companies and their affiliates must be kept up to date on, and understand differences from, their CORE positions. Using manual tools to spot deviations, however, is a time-consuming and tedious process. Because of Orbit’s RMP version comparison functionality, spotting deviations between CORE and Local RMPs is simple.
With a click of a button, users can compare their CORE and Local RMPs side-by-side, compare current and past versions of RMPs, and view changes and discrepancies between versions. Differences between the compared documents clearly show up as highlighted text which improves the user experience of locating RMP differences.
3. Communicating CORE
changes to local teams:
Once a new CORE version of an RMP is approved, global organizations should notify their local affiliates as soon as it’s possible. Historically this meant reaching out to all affiliates manually. For a global Pharmaceutical company, the speed with which a global team communicates this information to local teams is an important metric to watch. It’s also vital that local groups quickly acknowledge the receipt of new updates.
With Orbit’s platform, global teams can distribute new versions of their CORE RMP and aRMM to all their locals more quickly through the online platform, and local teams can see upcoming versions of CORE positions as they’re developed, allowing them to proactively plan for and analyze their future local RMPs.
4. Compiling information from local affiliates:
The majority of local teams are using spreadsheets to keep track of their activities. Those spreadsheets are then sent back to the global organization for compilation into one master record. People are busy, so acquiring these spreadsheets isn’t always as simple as it sounds, and usually, global teams must reach out to their locals regularly to remind them.
The process isn’t optimized. Orbit provides a more systematic way to share this content. Instead of chasing down local affiliates, Orbit stores and keeps track of local RMP-related data as local affiliates create and upload it, which ensures the global team always has access to this critical data.
5. Managing activities and commitments:
Manually tracking activities and obligations hinders your process management. As a result, you may face an increased risk of missed deadlines, and neglected responsibilities.
Key to the Orbit way of doing things is how it tracks activities and creates reminders, naturally enforcing best-practices, which doesn’t feel impressed upon the user. Individual users can keep on top of their assignments, without making managers feel like nags. At both the global and local level, this keeps your RMP workflow more efficient.