Blog Post
Clinical Research May Be Confusing Technology Adoption with Digital Maturity
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Andrea Bastek
Vice President, Market Strategy
Clinical research has spent the last decade accelerating technology adoption at research sites.
More systems.
More platforms.
More digital workflows.
More decentralized capabilities.
More site-owned infrastructure.
But our latest State of the Technology Survey suggests an uncomfortable possibility: the industry may be mistaking technology usage for digital maturity.
We asked sites to evaluate their own operational readiness across several dimensions of technology governance and adoption.
Some findings were encouraging:
- More than half reported having SOPs supporting eClinical technology use
- Many sites reported some level of system integrations
But other responses revealed a more complicated picture.
Only about:
- 40% reported having a clear change management strategy for technology adoption
- 29% reported tracking KPIs related to technology adoption, usage, or value
That gap matters.
Because digital maturity is not simply about having technology.
It’s about operational control over technology.
And under ICH E6(R3), that distinction becomes increasingly important.
Sponsors are now expected to provide appropriate oversight of technology used in trial execution, including systems operating at the site level.
At the same time, sites are becoming more technologically diverse:
- some operate sophisticated integrated ecosystems
- some rely on fragmented workflows
- some still operate partially on paper
- some are rapidly adopting new platforms without mature governance structures
In other words, the industry is moving into an era where sponsors may be responsible for overseeing increasingly heterogeneous site technology environments.
That creates difficult operational questions:
- How is system validation assessed?
- How are integrations governed?
- How is data integrity monitored across disconnected workflows?
- How is operational risk evaluated?
- How do sponsors assess whether site technology processes are actually mature?
Because using technology and governing technology are not the same thing.
A site can:
- implement multiple systems
- digitize workflows
- adopt eClinical tools
- support decentralized trial models
…without necessarily having:
- formal governance structures
- change management processes
- operational performance measurement
- technology optimization frameworks
That doesn’t mean sites are failing.
In many cases, sites have been forced to build digital operations reactively while adapting to sponsor demands, protocol complexity, staffing shortages, and constant platform variability.
But it does suggest the industry may need a more sophisticated conversation around what “digital maturity” actually means.
The next phase of clinical trial transformation may not be about adding more technology.
It may be about building the operational governance structures necessary to manage the technology already in place.
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