Sanofi: Designing a Data Management Strategy for the Future
Data management faces challenges: from the complexities of trial design to an increase in data sources. Patrick Nadolny, global head of clinical data management at Sanofi will share his predictions and goals for the next decade at Summit Connect, on 20 May 2021. Get a preview below, as he reveals some initial thoughts to Richard Young, VP CDMS Strategy at Veeva.
Moving from data management to data science
Nadolny believes the industry has moved past the inflection point between early adopters and the early majority in the adoption of new drug development practices. At the same time, data management teams are evolving towards clinical data science. Data managers now deal with an influx in data sources, both structured and unstructured, to inform their decision making, while their jobs grow to encompass working with a high level of new and complex concepts, including master protocols, risk-based CDM, and decentralized clinical trials. Their growing scope demands an understanding of people, processes, emerging technology, partnerships, regulations, and novel clinical research approaches.
The technology exists but we’re not ready
Technology has evolved enough to help tackle the new and increasingly complex challenges and handle a multitude of data sources. “The technology exists to move from data management to data science but”, says Nadolny, “none of us are ready. Many data managers don’t know how to use the technology that exists to assist them. They are used to moving from task to task and have not adapted to considering multiple unknown factors, decentralized workflows and different protocol designs.” He continues, “It is difficult to conceptualize such complex clinical trials and, while technology can play a part, information around how to adapt must be available to its users.”
Sanofi is focused on adapting and embracing technology. Nadolny is aware of the challenges it can present and feels he and other industry leaders would benefit from a playbook, which they are looking to Veeva and other suppliers to provide. Richard Young, VP of CDMS Strategy at Veeva agrees – he knows companies use technology as a stepping-stone, rather than address the future state. “How,” he questions “can companies make the right decisions about technology, if they are not fully informed?”
One foot in the past
While users need support to benefit fully from ever-improving technology, not all companies have committed to adapting their processes. Many companies use EDC systems with functional gaps, plugging these with custom functions, rather than adopting a new EDC that handles complex trial designs inherently. Equally, some organizations still use paper and spreadsheets, while others begin to use data lakes, workbenches and other new toolkits. Young is concerned that many companies keep one foot in the past, preventing them from making the journey from data management to data science. To move towards data science, Nadolny and Young agree, companies need to address these challenges and become future focused. To do this, they need the right education for users to benefit fully from technology.
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