Q&A with Novo Nordisk: Orchestrating Your Company’s Response to EU CTR

EU CTR has changed how large biopharma and emerging biotech companies operate since becoming mandatory earlier this year. Novo Nordisk’s Majbritt Romme (senior regulatory data professional) and Josef Jackson (senior clinical competency development professional) share how to address major operational changes necessitated by the regulation during an in-depth conversation with Werner Engelbrecht, senior director of strategy for Veeva Vault Clinical Operations. These include:

1. Collaborating across departments when faced with tight submission timelines
2. Harmonizing EU CTR processes with rest-of-world studies
3. Embedding new ways of working into a complex organization

Challenge #1: Coordinating cross-functional submissions to tight timelines

Sponsors that insource often struggle to coordinate submissions within the new EU CTR timelines, partially due to fragmented and time-consuming data collection. Creating a single cross-functional process and team structure helps to delineate new responsibilities.

Werner Engelbrecht: Which teams are represented in the Novo Nordisk taskforce, and how does it improve cross-functional collaboration?

Majbritt Romme: Our EU CTR taskforce was a cross-functional team from the outset and representative of key groups: regulatory, clinical, quality, safety, affiliates, and other business stakeholders. The taskforce came together in 2021 with a clearly defined purpose to assess the regulatory impact of EU CTR, define the roadmap, and create the strategy for critical workstreams (i.e., Novo Nordisk systems, future processes, and updates to SOPs).

We quickly realized we needed dedicated people to handle documents and data to succeed under the new regulation. New activities require proper resourcing and range from coordinating document releases between stakeholders and content providers to manual uploads to CTIS and monitoring. Specific people must be responsible for overseeing access control, personal protected data (PPD), and redactions.

After evaluating our approach, we set up a new team to manage all EU CTIS submissions centrally and a dedicated unit for redactions. As European affiliates are no longer responsible for CTIS uploads, headquarters and affiliates must work closely together toward the agreed submission date.

Challenge #2: Harmonizing EU CTR processes with rest-of-world studies

In addition to working toward mandatory implementation of EU CTR, companies want a globally standardized approach. Creating a single source of trial information and clarifying task ownership can improve oversight of rest-of-world studies.

WE: Given the challenging deadline, how did you also put in place a long-term solution?

Josef Jackson: EU CTR was our focus because of the hard deadline, but we always think globally. It meant that the EU CTR process had to align with the global submissions process and industry standards — or it wouldn’t be sustainable. We wanted to avoid going live with an approach based on workarounds, only to change processes six months later.

We contacted Veeva early — well before the regulation became mandatory on 31st January 2023 — for its perspective. Veeva’s business consulting team supported us by organizing a workshop to review our end-to-end processes. Given the number of people involved and the program’s complexity, this deep dive helped build alignment between all stakeholders. We have now defined a user-centric process with as few manual steps as possible.

Challenge #3: Embedding new ways of working into a complex organization

It’s not enough to create new processes and expect people to follow them. There has to be a business commitment to support users as they transition to the new model.

WE: How did you support your organization to embrace new ways of working?

MR: We proactively identified silos that were slowing down our teams. Knowing that coordination would be difficult in an organization of our size and complexity, we set up a ‘change agent’ network to smooth this cross-functional process. And we are also using our clinical and regulatory release teams to collaborate and communicate across the organization.

We’ve focused on training forums and providing guidance materials to improve our teams’ system and process understanding. There is a lot to learn from users, so we give them ample opportunity to share their feedback.

WE: What’s next for the EU CTR taskforce?

JJ: We want to optimize content plans to minimize potential errors when multiple people work on the same plan. Another big win will be introducing smart ways to extract structured data for submissions. Some pain is outside our control (we all know how challenging manual uploads are), but we’re hopeful that CTIS will introduce an external API to resolve this soon.

More time and experience with EU CTR submissions should help smooth the bumps we’re experiencing today. We are still in the learning phase, and our processes will continue to improve. We now have a robust foundation to build from as we continue to learn from each submission.

Learn more about the process changes required to succeed under EU CTR.