Quark Publishing Platform (QPP)

Quark Publishing Platform is a content automation software system that can help teams generate PSMFs and aggregate reports like PSURs at the push of a button. It does this using:

1. Tailored AI for standardised report building and copy generation, summarisation, tagging, discovery, reuse, translation, unstructured to structured content conversion and more

2. A structured content authoring approach where all content sections, annexes, citations etc. are broken down into individual components (essentially chunks of content) that are stored and managed centrally. These components can then exist in multiple documents at the same time. This means a component of content can be edited in one place and automatically update all the documents that it is used in instantly, providing efficient content reuse and editing power that saves hours and reduces errors. For example, you can edit the global PSMF and send an update to the local PSMFs in one simple process. This structured content approach is also the key to automation of content variables such as strict template formatting and structural changes which are required to meet each regulatory agency’s compliance (FDA, EMA etc) - and importantly is why AI can be more reliable and effective, as AI needs good structured content to provide accurate, trustworthy results. It also means you can connect to internal and external data sources like Excel spreadsheets, PubMed, clinicaltrials.org and more, to feed in dynamic data and notify of any changes that need looking at. This can also be integrated with Microsoft Teams and Office 365.

3. Human in the loop for real-time specialist authoring, collaboration and validation. All processes and workflows are automated to move content around the departments for validation, but will always require human sign-off, and contribution for subject-matter expertise where only a human can provide the required content.

So when the regulator calls demanding to see the PSMF, the document is all but done and up to date, so the team needn't descend into chaos and panic over the data points, validation audits and more - they can just revalidate and send.