Shorten Publishing Timelines by Switching from Traditional to Continuous Publishing

Submissions publishing can be a time-consuming process, often full of delays and rework. Many regulatory teams are starting to use continuous publishing processes to complete publishing tasks in parallel with other submission tasks, increasing efficiency and confidence in submission quality.

Regulatory experts from across the industry shared experiences and insights at a recent roundtable on the various publishing models – outsourced, in-house, or hybrid. Half of the participants who currently outsource publishing would like to eventually bring it in-house to gain better control, visibility, and reduce time spent on back-and-forth communication. Read on to learn how continuous publishing can improve implementation, execution, and business value.

Comparing traditional and continuous publishing

In traditional publishing models, regulatory teams wait for all content approvals before starting publishing tasks. Publishers often review and validate submission output at the very end of the submission lifecycle in preparation for publishing. As a result, it’s challenging to see how close a submission is to publication. And once the reviewer sees the final product, they will often need to make content revisions – combined with correcting last-minute validation errors, this process can strain teams and lengthen timelines.

Traditional Publishing

With continuous publishing, teams can conduct content review and approval in the context of the final eCTD output without waiting until the final step. Continuous publishing:

• Allows reviewers to check the consistency of messaging across documents, leading to higher-quality content.
• Enables regulatory teams to address errors before the document is approved, saving rework.
• Eliminates the potentially high number of issues that could have accumulated while waiting until all documents are ready.

Continuous Publishing

Continuous publishing makes publishing faster and better

Moving publishing tasks upstream and onto a single, unified cloud platform increases visibility, leading to faster submissions. With traditional publishing approaches, publishers must wait on other teams before hyperlinking and preparing documents for a submission. In continuous publishing, stakeholders can complete publishing tasks in tandem with submission planning and document authoring.

“You have access to your submission the whole time. It’s gone from a two-business-day turnaround for a safety report to half a day, just because it’s in-house.” said one roundtable participant.

For many companies, outsourced providers are still essential to the ecosystem. Continuous publishing works well for these teams, allowing these providers to work seamlessly within the environment rather than publish remotely.

Zentalis’ Regulatory Operations Manager, Charlene Pearce, said the continuous publishing approach also allows publishers to get subject matter experts directly involved in the publishing process. This results in fewer errors, easier validation, and reduces the number of submissions issues leading up to final publication.

All companies can benefit from continuous publishing, and the primary barrier to adoption has been change itself. “The only reason not to do it is because [traditional publishing] is how we have always done it.” said Charlene.

Elevating roles with continuous publishing

How well-prepared are companies to make the switch to continuous publishing? Some raised concerns about whether the effort to change to continuous publishing was worth it, or if their organization could support such a major change.

In continuous publishing, authors can be part of the publishing process with minimal change to their current approach. Publishers can eliminate time spent on manual work with hyperlinks and bookmarks to become data stewards who oversee and ensure the overall health of a submission from start to finish through higher-level publishing planning.

While this adjustment may seem daunting, regulatory teams can achieve the transition with adequate change management. Joy Piva, operations supervisor for regulatory systems at Pacira, overcame adoption challenges by investing in training and onboarding an in-house publishing team with support from Veeva services. “When you become the teacher, you need to absorb [information] quickly. We have 25% more submissions now compared to the last couple of years.”

We would like to extend a special thanks to all the experts who attended our publishing round table and shared their insights. If you want to learn more, watch this video on how Daiichi Sankyo used continuous publishing to transform its regulatory operations.