Reflections on the Nurocor Journey

by May 16, 2024

Frederik Malfait
Senior Vice President of Information Architecture

Reflections on the Nurocor Journey

I attended the 2024 CDISC European Interchange in Berlin where a lot of emphasis was given on the future CDISC strategy in general and more specifically on the role of digitalized study definitions and protocols. Unfortunately, the Nurocor booth materials were stuck in customs, but that didn’t get in the way to do a session presentation and participate on a panel to give a vendor’s perspective.

An obvious question came up multiple times during the keynotes and several other presentations: When can we start using digitalized study definitions and protocols? The answers were striking. Some ranged from 5 years to 10 years;the most optimistic from 2 to 3 years; and the more cautious that it will take time to do this. My own answer is that we can do this now. The question got me reflecting on the journey Nurocor has traveled so far and why we heard such disparate answers to a simple enough question.

The Beginning

In early 2018 Nurocor committed to the long term goal of building out a platform for digitalized clinical development. This was the start of what is today the Nurocor Clinical Platform (NCP). At the time digitalized clinical development was not a trendy topic. Study teams would diligently write their study protocols and statistical analysis plans in Word. At best, clinical documents would start from a template, but the information contained in it would be subject to interpretation. The information would be locked in documents and not be reusable or actionable. The document paradigm was prevalent, digital transformation strategies were mostly lacking, and large language models were nonexistent. It took a leap of faith to commit to digitalized clinical development in 2018.

Validation

Almost two years later in November 2019, TransCelerate started the Digital Data Flow (DDF) initiative with the publication of a white paper. By that time, the necessary infrastructure was already in place to release NCP as a microservice platform with core services, including applications for creating the study design and the schedule of activities. TransCelerate followed up with a six week hackathon in February 2020, for which a new NCP application was developed, capturing structured study and protocol elements such as study design elements, interventions and administered products, eligibility criteria, and template driven objectives and endpoints. Things accelerated from that point onwards. NCP applications for Lean Protocol™ processes, specimen management, and integrated clinical document authoring followed, while TransCelerate succeeded in greatly raising industry awareness. In 2022, TransCelerate partnered with CDISC to develop the Unified Study Definition Model (USDM) and implemented the Study Definition Repository (SDR), an open-source reference implementation of USDM. Another accelerator is the fairly sudden advent of large language models (LLMs), which has prompted (pun intended) companies across industries to adopt a digital transformation strategy. Finally, there is the upcoming ICH M11 protocol template and technical specification, which is expected to gain considerable regulatory traction.

It seems that Nurocor’s 2018 leap of faith has been validated as the way forward for what used to be a slowly moving industry. However, it is also not the end of the road. Work continues with new NCP applications to address innovative study designs, integrating insights and large language models, downstream automation, and upstream design center applications for supporting clinical development programs.

Adoption

So why did we hear such disparate adoption timelines at the CDISC Europe Interchange? I think the hint was in plain sight on one of Rob DiCicco’s slides during his keynote. The slide showed a bar chart of adoption percentages across different topics with digital protocol showing the lowest adoption. But there were two bars. One showed “digital protocol” with a 5% adoption, and the other showed “standardized digital protocol” with only a question mark. The former is where Nurocor is currently operating, and the latter is where CDISC is operating, which is a work in progress. So, it is worthwhile pointing out the distinction to avoid possible confusion.

When we talk about digitalized clinical development or digital data flow, we are really talking about ideas, strategies, and concepts. The Nurocor Clinical Platform is a real implementation and provides a unique opportunity for sponsors to adopt a “digital protocol” solution today. It is also designed to support the upcoming ICH M11 protocol specification.

A stable USDM specification to enable an industry “standardized digital protocol” is probably 2-3 years away from now. Most importantly, it will require high quality and stable API specifications that are critical to build out an interoperable ecosystem of vendor solutions. As of now, NCP has implemented a USDM compliant connector for each USDM iteration, but in our judgment, USDM will require a higher degree of maturity before it can be used in production-level implementations.

It should now be clear why I say that sponsors can use digitalized study definitions and protocols today. Nurocor has invested more than six years in developing a platform to do just that. Digitalized clinical development is our mission. The platform is validated GA software today, deployed at sponsors, and in production use for new studies. Now is the time for sponsor organizations to define a digital transformation strategy in general and adoption of digitalized study definitions and protocols in particular.