Regulatory content planning is a foundational step for any regulatory submission. A regulatory content plan is a outline of the pieces of content required for the submission, their due dates, and any other important information such as who is responsible for each artifact. Many regulatory professionals, especially those in emerging companies, may manage content plans in a project management tool such as MS Project, or in a spreadsheet software like Excel or Smartsheet.
However, having your content plan in a different system than the documents themselves can create a lot of unnecessary busywork, from tracking down a given document, following up with missing content, or having to re-flow entire project timelines after a delay.
But there is a better way!
With Kivo, you can store your documents AND build your content plan in the same tool, unlocking some pretty cool efficiencies for you and your team.
With that in mind, let's take a look at how you can leverage Kivo's Regulatory Projects to build and manage your regulatory content plans.
Let's say that you are working on a new IND. To keep your project on track, you can navigate to Regulatory Projects.
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Kivo offers out-of-the-box content plans (or "project templates") for common submission types like INDs that align to regulatory agency requirements. Projects include Milestones and Tasks. Each template is customizable as you adapt it to your process. You can Save as Template with a single click to use for future projects.
Let's open up one of these tasks.
Each Task can be associated with a bunch of information, including Assignee, Start and End Dates, Status, Group, Type, and Description. Tasks also include a Checklist of sub-tasks that must be completed, and can be linked to Dependencies.
But one of the coolest features is the ability to link the Task directly to specific Document(s) within the DMS. You can even choose to complete the Task automatically once the linked documents have been approved!
Finally, you can use the Kanban or Gantt Chart views to see if your Project is on track at a glance.
Accelerate content plan setup, get project status with a single click, and meet regulatory milestones with greater confidence.
Win-win-win. 😎
We're rolling out intelligent date automation for these regulatory projects in our webinar next week (i.e. need to adjust a single date? Watch the rest of your timeline re-flow like magic 🪄) Join us on May 23rd to see how it works! And to get a quick overview of our full Regulatory capabilities, check out this click-through demo.
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See ya next month!
