Blog Post

Clinical Research Needs to Replace Paper and Email Without Adding More Layers

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Andrea Bastek

Vice President, Market Strategy

For years, the industry narrative around document exchange has centered on digitization.

Paper binders became eISFs.
Mail became portals.
File cabinets became cloud platforms.

But our latest State of the Technology Survey suggests something more complicated happened.

The industry didn’t replace old exchange methods.

It accumulated new ones on top of them.

Across sites, sponsors, and CROs:

  • 95% still exchange documents through email
  • 72% still exchange documents on paper

At the same time:

  • 84% use sponsor/CRO document portals
  • 79% use sponsor/CRO eISF/eReg systems
  • 76% use site-owned eISF/eReg platforms
  • 73% use generic file-sharing tools like Dropbox or SharePoint

In other words, the industry didn’t converge around a single operational model for document exchange, it layered multiple models together.

And every additional exchange method creates operational consequences.

Take portals, for example. Portals are often framed as digital transformation.But operationally, many portals function as transfer layers:

  • download document from one system
  • upload into another
  • notify someone by email
  • reconcile versions
  • repeat

The document is digital. The workflow is still manual.

Generic file-sharing platforms introduce another layer of complexity.

They’re flexible and familiar, which explains their widespread use. But they also raise important operational questions:

  • Are they validated?
  • Are they designed for regulated workflows?
  • How are permissions managed?
  • How is version control maintained?
  • What happens during inspection readiness activities?

And despite all the specialized systems now available, email remains nearly universal.

Why?

Because email still acts as the operational glue holding fragmented workflows together.

When integrations fail, people email.
When portals are confusing, people email.
When systems don’t align, people email.
When urgency increases, people email.

Paper serves a similar role.

It persists not necessarily because the industry wants it to, but because operational edge cases still exist everywhere:

  • wet signatures
  • site preferences
  • workflow gaps
  • hybrid processes
  • technology limitations

The uncomfortable reality is that clinical research may not have fully digitized document exchange.

It may have simply created more places where documents can live.

And unless those systems become more connected, more interoperable, and more operationally aligned, the industry risks increasing com

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