State of the Industry
Digitalization of the Clinical Development Life Cycle
Clinical trials are disconnected, labor intensive, expensive, and development of new medicinal products face long time-to-market cycles. This hurts everybody along the clinical development lifecycle and delays important life-saving therapies for individual patients and public health at large. The recent pandemic has brought these issues to the forefront.
At Nurocor we believe a digitalized study design and protocol – with supporting clinical data standards and process automation – is key to the future of clinical development; it is the cornerstone to design effectively and efficiently, plan, execute, and submit studies. Today, the information locked up in documents needs repeated interpretation and transcription, and is not fit-for-purpose to streamline or automate business processes. This also presents a serious barrier to entry to apply business analytics, particularly the use of machine learning for optimizing study design and execution. It may be possible to develop (limited scope) point solutions, but so far it has been elusive to consistently integrate such solutions into a wider system and business process landscape.
As stated by Paul Hudson (CEO, Sanofi) in Fortune Magazine – “as an industry we need to have the courage and preparedness to abandon our old ways and begin building a fortified foundation for strategic digitalization.” It is therefore essential to take a digitalized and interoperable end-to-end approach from protocol (or even better: from the clinical development plan) to submission.
This has been the vision and commitment of Nurocor since inception in 2017. Nurocor has developed a new, modern, microservice-based, and API-first platform – known as the Nurocor Clinical Platform (NCP) – which makes this a reality. NCP enables full end-to-end digitalized clinical development, providing a pathway to bring drugs to market more quickly, and saving on average 8 months and $8 million on a typical Phase-III clinical trial.
NCP has proven it is possible to create a validated and production-ready platform for digitalized study design and protocol development, including supporting standards and process automation. But what about adoption? In early 2019, the question of industry readiness, let alone adoption, was wide open. We also know that change in this industry is typically very slow, so the question of adoption weighed quite heavily. A breakthrough happened later in 2019 when TransCelerate released a whitepaper on Digital Data Flow (DDF), followed by the DDF Hackathon in April 2020. These events propelled a much needed mindset shift across the industry, leading pharmaceutical companies to consider major process and system changes more seriously; thus moving away from document-based solutions so that information can become actionable.
Fast-forward to September 2021, when TransCelerate formalized the DDF initiative in partnership with Accenture, CDISC, and Microsoft.
“The initiative aims to move the drug development process from a current state of manual, study start-up asset creation (i.e., Case Report Forms, Procedure Manuals, Statistical Analysis Plans, and Schedule of Activities) to a future state of fully automated, dynamic, study start-up readiness…” (TransCelerate website).
For more information on the DDF Initiative, see overview video.
As a market leader in digitalized clinical development, Nurocor has been an active participant throughout the DDF Initiative. The deliverables of this collaboration are twofold. CDISC is committed to delivering an approved standard for a Unified Study Definition Model (USDM) side-by-side with an API specification. DDF is committed to delivering the Study Definition Repository (SDR), a reference implementation of the API. A first iteration concluded in mid-2022, with a provisional USDM standard published by CDISC August 2022, followed by a DDF Connectathon in September 2022.
Working with Oracle, Nurocor achieved a Distinguished Submission for connecting NCP to the SDR, and demonstrated end-to-end EDC automation through the Nurocor Schedule of Activities application.
For more details, please join our speaker panel “Automating Study Setup with a Digital Data Flow” as part of the Oracle Innovation Series Tuesday, December 13.