The Digital Protocol: A Breakthrough 

The Evolution of Digital Protocols: From Past to Present

A quarter of a century ago I was involved with the development of an innovative macro-driven protocol template.  It collected meta-data through a series of prompts upon opening. We dubbed it the digital protocol. Hhhmmm! A convenient label at the time, but what’s in a name? Evidently quite a lot.

Today at Nurocor, we have pioneered the first true digital protocol, built from a set of simple, structured, standards-based applications. In fact, our digital protocol isn’t a traditional document at all—it’s a composition of artifactual elements, components, and libraries, resulting in a consistent and actionable study definition. We are now releasing a digital authoring application that allows the components of the digital protocol to be seamlessly combined with conventionally authored contributions to create the consolidated documents required by all regulatory authorities.

This new addition to our platform enables a revolutionary approach to document authoring. Having just taken a lead role in user testing the new application, I can confidently say it feels like a breakthrough. It combines digitized standards, structured authoring principles, and single sources of truth with 360 document oversight. Plus, it aligns with industry standards, including ICH M11 (check out our blog on ICH M11).

Too good to be true? Read on for the highlights following the release of our new authoring application.

User Experience: The Highlights

• Dynamic, Structured Authoring: Navigating Accountability
• Single point accountability has always been a hot topic. In my last company, interpretations were split between document-level and functional-level accountability. By embedding agility to assign ownership at both levels, we can seamlessly adapt to our client’s processes. The dog wags the tail!
• Quality Through Information Flow and Programmatic Controls
• Quality! We know it when we see it, and we know when we don’t. Although difficult to objectively measure, consistency of styles, formats, abbreviations, citations, and data sources is fundamental. By centrally configuring formats and styles, by using incorruptible templates, and by allowing key information to flow from a single source, we introduce quality by design. No more formatting tasks for us!
• Mastering Document Control and Contributor Transparency
• Back in the day, I sent out drafts via email, or even as hard copy. Now, with collaborative tools and document management systems, those days are hopefully behind us. But we’re not stopping there. Our focus on transparency permits contributors to see which sections are under review, who is reviewing, what feedback they’re providing, and when they started and finished. This level of visibility prevents duplicate comments, eliminates proliferation of document versions, and will ultimately enable valuable analysis of reviewer behavior.
• Unveiling a New Approach: Continuous Improvement and Building Trust
• Introducing a brand new approach to managing content and review cycles to real users was bound to surface some challenges—no surprise there, given the almost infinite combinations of options. Minimizing these risks is crucial, and that’s where end-user feedback comes in. It’s all about catching those hiccups early. Seeing real users interact with our product has given us a huge amount of confidence that we have the right features, and the feedback collected is allowing us to focus on refining the user experience to remove friction and ease adoption.
• Mastering Change Management in Document Creation
• When it comes to change, our perception of risk often stems from past experiences—better the devil we know, right? In our new world, content components, formats, and styles are standardized and implemented organization-wide, moving away from personal judgement. However, as we go through the early stages of implementation, gaps in process, knowledge, and systems may appear as we shift paradigms.
• That’s why partnering with stakeholders to implement solutions that promote close collaboration and mutual understanding is essential right from the start.

Conclusion: Embracing Digital Protocols 

Our composable authoring system places quality and efficiency at the forefront through structured information flow and programmatic controls. Change is always hard, but adapting to single sources of information is crucial for evolving our processes and achieving seamless, efficient authoring as part of a digital data flow solution.

Looking ahead, we’re excited about integrating AI solutions and authoring metrics to further refine our document creation capability. This journey requires collaboration and mutual effort as we embrace change and innovate together.