Overview

This is a summary of a project that Astrix led that involved implementing a Regulatory Information Management system for a top ten Pharma company. It discusses how we worked closely with the client and the Veeva team members to support the organization’s end-to-end Veeva RIM implementation.

Current Situation

Before Veeva, this organization’s global teams were leveraging disparate sets of tools and multiple LAN areas that were storing information on multiple SharePoint locations. These homegrown tools were purpose built and not connected. There were also quite a few spreadsheets.

This may sound familiar to those reading this because it’s quite a common theme, especially in Regulatory processes as they require coordination of information globally. There are often multiple tools leveraged across regions to plan, track, and manage submissions. Due to different regional requirements and a simple divergence of methods over time, the global teams don’t always share the same processes or even the same terminology.

This organization was attempting to evolve their RIM ecosystem into a globally consistent RIM solution leveraging Veeva’s RIM system including Global Regulatory submissions, CMC submission, Safety submissions, and everything in between.  To that end, they engaged Astrix to help on their multiyear journey to work with them to:

• Assess the global current state
• Define a harmonized future state
• Develop initial requirements and support configuration sessions for globally harmonized processes for:
  • Submission planning
  • Tracking o Authoring
  • Publishing
  • Submissions
  • Archiving
  • Correspondence •
• Plan and manage migration and integration workstreams
• Plan, manage, and support the onboarding of users to Veeva RIM (e.g., adoption planning, communications, and training support, etc.).

Business Background As part of our process, the Astrix team engaged both the client team and Veeva to understand and document the processes, issues, and opportunities, before collaborating with subject matter experts and core team members to design what the future state would look like. The Astrix team also worked closely with the Veeva team members to gain their valuable knowledge and input along the way on best practices and suggestions. At each point, leveraging unified cross-company (Veeva-Astrix-Client teams) enabled us to drive this successful implementation supporting processes for major market submissions, regional markets, annual reports, promotional materials, labeling submissions, and CMC submissions.

The project included everything from planning and tracking, through to the authoring of the actual submission of that material to the health authority. Moreover, it included the archiving of any recurring and follow on activities like management of correspondence, updating of outcomes and registrations, and post approval activities.

Moving from the initial requirements definition, we worked to support Veeva’s configuration teams, define rollout strategies, plan for user adoption, and identify migration and integration needs.

The approach that Astrix takes with any project can be boiled down to a couple key steps:

• Define the company’s vision
• Identify capabilities required
• Create a plan, and
• Manage the change

With this global pharma organization, they had already done some of the legwork on their own. They knew the vendor they wanted to implement, which of course was Veeva, and they had done some of the work to define their high-level vision and goals. Astrix came in at this point to assist with driving the detailed requirements and business analysis, and to create and manage the plans for implementation and rollout. Additionally, to help the organization manage that change management through adoption planning stakeholder analysis and communication.

Astrix and Veeva worked closely together to drive workstreams, implement strong communication channels and to define and prioritize capabilities and processes.

A key element was managing “Workstreams” which were established for each of the impacted organizations (e.g., CMC workflows, safety workflows, and regulatory workflows) and the major workflows (e.g., Authoring, Archive, etc.) Breaking the work down like this ensured that we had the right teams in the right meetings, and we were able to focus our efforts on each area.

All workstream teams consisted of the client company’s business and IT representatives in addition to Astrix and Veeva team members. It was extremely important to have all of those represented because we were able to incorporate all perspectives throughout. Everyone had a voice.

Moreover, we engaged subject matter experts and adjacent organizations like safety, clinical, or stats where it made sense (for example integration with clinical systems relied on SMEs from clinical and stats).

Ultimately, we wouldn’t have been able to accomplish what we set out to do without strong communication channels, both within each of the workstreams and between them. We leveraged Microsoft Teams channels significantly as well as Kanban boards along with weekly check-ins, workshops, and daily stand-up meetings.

Additionally, we made sure to accommodate global team members and ensured that we were scheduling meetings at times when they were available. Careful consideration in planning discussions, roll out strategies and training were given to make sure that submissions work kept running and teams were able to hit their targets – where needed, timelines were managed and adjusted to make sure Regulatory work remained unimpeded.

Another important aspect of the implementation that Astrix assisted our client with, was the “Process Readiness”. Regardless of which workstream there was an element of this Process Readiness. This enabled the team to focus on laying the groundwork and establishing that future state.

We first led the team through an assessment of their current processes which served as the foundation from which to build the future vision and process. By leveraging a framework of common capabilities, we were able to draft and adjust requirements to reflect the nuances of this organization’s unique workflows. Each company we work with has similar goals (e.g., author, publish, submit, track approvals, etc.) but the way they navigate getting there varies, we therefore wanted to make sure that we understood, in a detailed fashion, what this company was doing and why. What worked for them, as well as what didn’t, so we could build even better workflows in Veeva as we moved forward. We worked closely with our global subject matter experts to align on those processes and on key terminology.

Additionally, we uncovered critical global differences along the way. One, for example, was that Correspondence may mean emails to one region and emails plus meeting minutes to another, and still, something different to a third. When we encountered differences like this, we worked to bring everyone together and come up with a harmonized future state. It was critical that we gained agreement on these various items so that everyone globally was aligned to what it was going to mean when they moved to the Veeva RIM system. It also helped significantly to have Veeva part of these conversations. This enabled the client teams to better understand the terms that were used within the system and how that might impact workflows.

Process assessments enabled definition of initial requirements which were then configured by Veeva into the new system. Later workstreams, we built on those initial requirements, and took us into real scenarios within the Veeva RIM system. Together with the Veeva representatives we developed and tested use cases to identify specific configuration changes that were needed. We brought together subject matter experts, where it made sense, to help clarify and provide guidance. Moreover, we documented and communicated those outcomes and used those configuration items and discussions to prioritize into release plans.

Another important area where Astrix assisted this client was with their “Data Readiness” though planning and management of migrations from legacy systems and integrations with adjacent systems. When developing these plans we had to consider not only what was happening within the RIM system, but also what was needed to support the integration from the adjacent organization (e.g., where configuration changes might be needed in other systems, other initiatives impacting this work, how data could flow through their Electronic Data Backbone, etc.) Astrix’s program management work here facilitated client teams and Veeva to successfully complete technical work needed to support migrations and integrations (e.g., standing up various Veeva environments, updating configurations, mapping data, developing migration tools, etc.) As a team, we met regularly to identify and remove any blockers and leveraged the communication channels that were discussed previously.

All of the aspects of this project reviewed thus far became inputs to release plans, and accompanying release plans were adoption plans. Here we worked with subject matter experts and our core teams to outline the set of activities that were needed to understand and communicate with impacted stakeholders, to develop and provide training materials, and to support those users in their onboarding.

To manage all of these parallel workstreams, we leveraged weekly leadership meetings, workstream dashboards, workshops, daily stand-ups, and instant messages. As users were onboarded, we kept them informed of new capabilities, feature, and job aids through newsletters and intranet sites.

Ultimately, Astrix’s Program Management teams have become an integral piece of the puzzle and intertwined within these cross-functional teams that we are able to anticipate our client’s needs and be a champion for their continued success.

Considerations

To recap, there were six common themes that came up during this project that are important to note since they also surface on many enterprise implementation projects. They are…

Team members bandwidth

We often ran into challenges with core team members on multiple workstreams. We had client team members that were in some cases leading a workstream or in others participating in multiple workstreams. We also had subject matter experts who had to keep the submissions going on target while they were providing input into these workstreams, so we needed to make sure to accommodate those critical deadlines and ensure that we were working alongside what their schedules permitted. We had to plan for data migration and user onboarding around key submission dates as well, because we didn’t want to interfere with any critical dates or delay any submissions. Therefore, we often needed to revisit timelines as things shifted in the portfolio.

Coordinating time zones and global teams

Coordinating time zones and global teams is not an easy task. It’s easy to forget that someone’s on a meeting at 4:00 AM or they just joined after they put their kids to bed. It’s important to consider people’s schedules so that you are accommodating their work-life balance while also getting the input needed to drive work forward.

Workstream dependencies and parallel efforts

This is really around impact on individual workstreams on the overall implementation plans. If one workstream slips, it affects all downstream targets. Strong communication and visibility are key to staying on track with everything going on all at once.

Impact of system and process changes to business users

It’s easy to think that the system is going to solve everyone’s problems, however, it introduces change and anytime you introduce change you’re introducing a learning curve. Veeva systems created many efficiencies for this company; however, it was also difficult to meet some of the complicated business processes and rules that have been baked into decades old legacy systems, so we had to consider how users were performing the work currently and what those changes would mean to their day-to-day operations.

Product Enhancements and Veeva Roadmap

One way we were able to address negative process changes was through Veeva’s product updates. The team continued to work with Veeva to identify and implement new capabilities in order to optimize workflows. Ongoing (or upcoming) work in adjacent organizations Adjacent organization’s bandwidth presents another challenge. When workstreams require input from those adjacent organizations, but there are competing projects or work going on in those areas of the business, it impacts the workstream processes and can delay important feedback. It’s important to ensure that this factor is considered with project plans and timelines.

Summary

To summarize, we partnered closely with Veeva Systems and our client on this implementation to successfully implement the Veeva RIM solution. We leveraged strong program management and experienced team members across parallel workstreams to drive the project. This Global Pharma company is currently leveraging a successful Veeva RIM implementation. Next up on their list is to expand their use cases and to look towards further optimizing processes and regulatory intelligence automation.