Data Standards: Streamlining the clinical trials of today and building a competitive advantage for tomorrow
Organizations who invest in data standards now are optimizing today’s processes and technology, improving process automation and functional collaboration, and streamlining data flows from source to submission while setting the foundation for evolution to the clinical trials of tomorrow.
In today’s world of the COVID-19 pandemic, rapid development of life saving therapies is more critical than ever. Clinical Development Organizations (CDOs) must focus on innovative approaches to accelerate the product development lifecycle and gather real time actionable insights from the ever-increasing volumes of data while maintaining quality and efficiency.
Acquisition, aggregation and submission of clinical trial data has always been a challenge. The average study now collects over a million data points, and this is increasing all the time. As data from additional sources such as RWD and RWE as well as the adoption of AI, ML and NLP bring transformative benefits to drug development and clinical outcomes, we are quickly approaching a world where data sets of 500 gigabytes or even terabytes may be the norm.
Data standards accelerate the integration of data sources and the ability to connect data across disparate systems.
Data standards are the catalyst to reducing time-to-market for new drugs, by driving automation and streamlining data flow from study design through to execution and submission while improving quality and compliance and reducing costs and timelines
Digitalized Clinical Development
Innovative Clinical Development Organizations (CDOs) take advantage of standards during the planning stage, the earliest point in the development process. Standardization of protocol elements, introduction of an end-to-end process for clinical development standards and the utilization of TransCelerate’s Common Protocol Template (CPT), coupled with the right technology, provide a platform for planning and executing trials more efficiently with a goal of getting products to market sooner.
Nurocor provides a set of documented data standards, has defined the Lean Protocol™ Process, and automates the application of these standards and the Lean Protocol with the Nurocor Clinical Platform.