Nurocor Roadmap to Digital Data Flow

Little by little, one travels far
Spanish proverb

At Nurocor, we are reaching a tipping point in our product offering that can significantly transform clinical research from a paper based world to a digital protocol driven collaboration platform. It seems therefore a good place and time to look back at the road travelled, to take in the current landscape, and to put a mark on the map where we would like to be two to four years from now.

The journey started three years ago when Nurocor established a leading position in the metadata registry (MDR) market for pharmaceutical companies and contract research organizations. This is a fancy way of saying that Nurocor provides the leading industry platform for managing clinical data standards, and to do so at enterprise scale. This is a significant capability: compliance to clinical data standards is a key regulatory requirement, and managing those standards is an inherently complex process.

It would be tempting to think that a solid MDR solution would settle the matter and we could just continue to add more features and be done with that. As tempting as it sounds, it also ignores the true significance of standards and the actual problems we are trying to solve. It took the pharmaceutical industry a decade from “adopting clinical data standards by necessity” to start embracing it for its real value. In fact, many organizations are still struggling with the latter. So, why is that? Initially, standards were seen as a nuisance or liability, a regulatory check box that needed to be ticked off. Over time, standards became recognized as an asset that could be leveraged for other purposes, e.g. to facilitate the EDC build process and the mapping of collected data to submission datasets. Some of these gains have partially been realized, but they have been only tactical in nature. Most organizations get stuck at this point.

To make further progress we need to think more strategically about the role of standards and their place within the clinical research life cycle. One thing is clear: standards currently don’t cover the full life cycle and enter the life cycle far too late after final protocol. Which leads us to the key problem: protocols are paper based, protocol development is not informed by data standards, protocol information is not actionable, and downstream automation is not informed by the protocol. Trying to integrate a comprehensive digital based standards process with a paper based protocol process can only fail. We need a digital protocol. In fact, we need to rethink the clinical research life cycle itself and recast it to a full digital format.

At Nurocor we started work in this problem space about 18 months ago, and we have now reached the first major milestone. The Nurocor Clinical Platform (NCP) is a microservice based technology platform to support current and future development of standards driven Digitalized clinical development. It implements an enterprise class, cloud based, and scalable platform with a common application infrastructure for API gateway access, authentication, authorization, logging and audit, notification services, workflow, and a unified UI experience across applications. Each application can be developed with its own technology stack and deployed as a microservice within NCP. Existing Nurocor applications have already been migrated to the new platform and we are encouraging existing customers to take advantage of the new infrastructure.

With the platform in place and existing applications migrated, Nurocor is now laser focused on developing a full digital protocol solution within NCP. During the summer of 2019 we broke up the solution design for a digital protocol into four components (schedule of activities, protocol elements editor, structured authoring, study disclosure) and decided to tackle the most complex component first: a web application to create a schedule of activities, informed by study endpoints and MDR driven clinical data standards, integrated in one easy to use user interface, and ready to automate the downstream EDC study build. An advanced prototype has been demonstrated at the 2019 CDISC Interchange and a product implementation has been completed as part of Nurocor’s submission to the Digital Data Flow (DDF) hackathon challenge, where we were awarded a Distinguished Submission. This effort has been a catalyst to fast track our work on a comprehensive MDR based protocol model, an editor for protocol elements, and a solution for protocol disclosure. Nurocor has a Production-quality release of our DDF capabilities available for customer today.

We will then continue work on a web based structured authoring application that can be used to create digital documents across the clinical research life cycle, in particular the study protocol, the statistical analysis plan, the clinical study report, and any functional plans needed for study execution. Structured authoring will be template driven and backed by a common data service spanning across all applications to ensure content reuse in an easy and transparent manner.

This will achieve a solid technical solution for the key problem we outlined earlier: protocols become digital assets, protocol development is informed by data standards right from the start, protocol information becomes actionable, and downstream automation is driven by integrated protocol and standards content. In addition to the technology track, Nurocor is working on a parallel track to create valuable MDR content libraries to support these applications out of the box. For the hackathon challenge we have already developed an extensive library of Safety activities. Over the next nine months Nurocor will be creating additional libraries for TA and indication specific activities, QRS (questionnaires, ratings, scales), lab specifications, protocol and disclosure elements, objective and endpoint templates, eligibility criteria, and authoring templates.

Looking ahead to 2021-2022, Nurocor intends to leverage a standards driven digital protocol platform to achieve more strategic objectives beyond only tactical gains. Two key downstream objectives are to accelerate important trial execution milestones and to reduce the number of amendments. To achieve these objectives, Nurocor will refine, augment, and integrate the digital protocol solution with a Lean Protocol TM process approach supporting trial preparation, execution, and close-out. Analysis of these processes is already underway and application designs are expected to start this year, so that implementation can follow in 2021. Whereas downstream objectives focus on achieving quality and time to market, upstream objectives focus on improved and informed decision making. There are many topics of interest in this area, but we would like to highlight a couple that are on the Nurocor roadmap for 2021-2022 and beyond. The smallest unit of interest is not a single trial, but rather a clinical project aiming to bring a drug to market. Nurocor intends to create a digital solution for clinical projects, tactically to support a digital Target Product Profile (TPP) and Clinical Development Plan (CDP) that can seed protocol planning, and strategically to build out an advanced project design center to support smart and innovative study design. At a higher level of consolidation, Nurocor intends to aggregate information at the project portfolio level to support executive decision making in aligning the product portfolio with corporate strategy, optimizing the existing portfolio, and balancing the portfolio with new projects.

This is a bold agenda, but at Nurocor we feel that now is the time to execute on this vision. We have a leadership team focusing on essential and high value issues, a top notch development, operations and QA team that knows how to build reliable, scalable, and enterprise-level software, and a professional services team that has a proven track record of implementing customer projects on time and on budget.

We are excited to take on this challenge, and to work with customers and partners to make this vision a reality.