Now that the dust has settled from the official launch (including our company retreat and two back-to-back conferences - whew!) we’re finally able to put pen to paper on what makes Kivo GO so great.
Let’s dive in.
Clinical, Regulatory, and Quality, all in one.
Probably the biggest aspect of Kivo GO is how it unites all three functions - Clinical, Regulatory, and Quality - in a truly unified system (and for one price). That means you get a QMS, eTMF, and RIM (plus an eCTD Viewer) with every Kivo GO license.
This is a gamechanger, especially for emerging pharma and med device companies.
Until now, these smaller organizations have had to choose which service they need the most (ie, “do we need a QMS or a RIM system more right now?”), or try to get an expensive contract with an ‘enterprise’ solution approved by the finance team. More often than not, this results in purchasing piecemeal software that doesn’t integrate with each other, and/or a whole lot of manual work like tracking spreadsheets in lieu of a software solution. Either way, teams have to fight their platforms and workflows to get things done.
Kivo GO changes that. We can now offer these scaling organizations a fully compliant, validated document management software for all three functions at a truly reasonable price, speeding up collaboration and keeping things compliant - without giving finance a heart attack.
Every function for every team - all in one place
Project Management
Regardless of your function, you need to keep things on track. Many projects, from site management, CAPAs, submissions, and more follow somewhat predictable patterns. Yet these projects are often managed manually in disconnected systems. With Kivo GO’s project management capabilities, you can create templates for these repeatable projects, complete with due dates, checklists, tasks assignments and more. Then, you can visualize your projects in timeline or Kanban view based on status. To complete the workflow, you can customize alerts or related reports to be delivered to your email.
Let’s check out how that works.
For Clinical:
Accelerate site startup activities
Study startup is a critical juncture in any clinical trial, and it’s essential to stay on track as much as possible. With Kivo, you can standardize these activities from a project management standpoint and track status at a glance, giving you better visibility into your trial.
When adding a new project - for example, a new phase 1 trial - into Kivo, essential tasks for site selection, site startup, greenlight packages, and more will automatically populate per the project template. Project templates are fully customizable within Kivo, but also work out-of-the-box for those of you that just need to get started.
Each task can be assigned to the proper individual. Users can monitor assigned tasks and status directly on their home page. Tasks also included configurable checklists of actions. You can choose to have the main task automatically marked as complete when the checklist is completed. Tasks can also have dependencies, so you can easily track blockers. Finally, you can link related documents directly to the task, from anywhere in the DMS, with an easy drag and drop. If you choose, you can set the task to auto-complete when a linked document is approved.
Should events occur such as a protocol change, investigator change, or supply chain issue, you can add a new “event” into the project plan. Doing so will add the event and the related tasks into your project plan (related tasks are also fully customizable). This approach allows you to handle changes in your projects in controlled ways that align to your SOPs.
Finally, you can use the Kanban view to see at a glance which tasks are on track or blocked, or leverage the new reporting module to run a variety of reports (more on that later in this article).
For Regulatory:
Keep submission timelines on track
When you create a new submission as a project inside Kivo, Kivo will automatically create a project plan based on the submission type, broken out by milestone. The project plan is completely configurable to match your ideal process. Tasks are grouped according to milestone and general area of work, or “group”. Each task can be assigned to an individual and tagged with status, start and end dates, and task type, such as content. Just like trial management, tasks can include checklists, dependencies, and linked documents.
All this information allows you to run reporting on each submission in a variety of ways. See status at a glance in the Kanban view, or run reporting on an individual’s assigned tasks to see who is behind on work. If it’s tagged in the system, you can run a corresponding report.
For Quality:
Streamline CAPAs
Similar to the other examples we’ve covered, CAPAs (as well as Audits, Deviations, and change controls) can be managed with project templates customized to your SOPs. When you initiate a new CAPA, a project plan will automatically populate with your tasks. Just like other areas of Kivo, each task can have sub-tasks in a checklist format, dependencies, and linked documents.
As the CAPA progresses, you can add events to capture your findings and recommendations. Events (such as Preventative Action or Corrective Action) can also be templatized. When adding one of these events, the necessary tasks will be added to your overall project plan.
This allows you to standardize how CAPAs are handled, speed up manual tracking, and enables flexible reporting based on status, individual, or date.
Intelligent, flexible reporting
Under the hood, the unified nature of Kivo GO enables some seriously powerful reporting and workflows.
When you upload a document into Kivo GO, regardless of whether you’re uploading into RIM, eTMF, or QMS, you are adding content that can appear in multiple locations throughout the system. A protocol can be authored in Regulatory and surfaced in the eTMF. Manufacturing information can be shared between Quality and Regulatory. Investigator and vendor information between Clinical and Quality.
This reduces the rate of version control issues, breaks down silos and information hand-offs between departments, and creates richer reporting throughout the system.
By coupling Kivo's process and document management features, rich user experiences are unlocked.
Here are a few use cases:
Let's say that you are supporting an active submission and receive correspondence from the health authority. You can use Kivo's correspondence management feature to capture the correspondence and details. Any commitments can also be captured and tracked. If the query results in a new submission you can utilize Kivo to automatically generate the submission project, create placeholders in the DMS for the documents that need to be authored and view the status of everything in a dashboard.
Next, let's say you are managing SOPs in Kivo. You can define periodic reviews in Kivo and automatically get notified 90 days before an SOP needs to be reviewed, and potentially updated and approved. Once approved you can assign the updated SOP to employees for training. Everyone will get notified via email and in Kivo that they have been assigned training and when they complete training records will be automatically updated.
Finally, you’re working in Quality managing your vendors. If your SOP indicates that each vendor needs to be audited every 2 two years you can get notified when it has been 21 months since the last audit. You can easily kick-off a new audit project in Kivo that has steps that align to your SOP on Vendor Audits. At the completion of the audit you can generate a new event in the Audit project to capture audit findings depending on their severity. Documents for the entire process are captured in the DMS and linked both to the vendor and the audit project giving you complete visibility into all of your vendors and status.
In summary, we truly believe that Kivo GO can significantly improve collaboration, reduce manual work, and speed up essential projects.
If you haven’t had a chance to check it out, go check out our platform here. And if you’d like to discuss how Kivo GO can help your team, schedule a demo or request a free trial. We can’t wait to speak with you!
