Spreadsheet-Driven Trials: Why Excel Still Creates Risk in Clinical Research
- Jagdeep Saran
- Apr 13
- 4 min read
Most clinical research teams will say they don’t rely on spreadsheets that much anymore. Then you sit with them for a day and see how often Excel shows up anyway, usually when nobody expects it.
None of it feels risky at the time. But over the life of a study those small spreadsheets start to carry more responsibility than anyone really planned for.
Over time the spreadsheet stops being a tool and starts acting like infrastructure.
The Convenience Problem
There’s a reason spreadsheets are still everywhere. They’re fast, familiar, and in research environments where timelines shift constantly, speed often wins over structure.
Setting up a new platform takes coordination, approvals, conversations that stretch longer than anyone wants. Even when organizations already have dedicated systems, teams still export data into Excel because it feels easier to review there.
The real issue isn’t that spreadsheets exist. It’s that they slowly turn into decision-making spaces without the governance clinical research requires.
Version Control Isn’t a Technical Issue, It’s a Human One
Anyone who has worked on a multi-site study has seen filenames like “final_v2_updated_REAL.” Nobody intends for it to get that messy, it just happens over time.
One person downloads a copy to review offline. Someone else adds columns. Another team member emails a revised version without realizing someone else already changed the file. None of this feels dramatic in the moment, but a few weeks later no one is fully sure which version is the source of truth.
In regulated environments that uncertainty matters more than people expect. Audit trails data lineage accountability, these aren't just abstract ideas. They actually affect how studies get reviewed and whether people trust the results.
Compliance Doesn’t Break Overnight
When people talk about spreadsheet risk they imagine big failures, something obvious. In reality the problems creep in slowly.
Permissions drift. Sensitive data ends up in places it shouldn’t be. Small changes get made without context attached. By the time anyone notices, the spreadsheet is already woven into daily workflows.
Regulators like the U.S. Food and Drug Administration and the National Institutes of Health expect strong governance practices, everyone knows that. Most teams think they're compliant, or close enough, and honestly they usually are trying. The problem is the tools don't always support that, without built-in structure consistency starts slipping even when people think things are under control.
The Hidden Cost Is Time
The biggest impact of spreadsheet-driven trials isn’t always compliance risk. It’s the hours teams lose keeping everything aligned.
Project managers compare versions. Data managers rebuild context that should have been captured automatically. Researchers double-check formulas, sometimes twice, before trusting the numbers. Still, over the course of a long study those small inefficiencies accumulate.
Why Change Feels Harder Than Staying the Same
Part of it is familiarity. People trust tools they’ve used for years.
Timing matters as well, adding new systems mid-study can feel risky even if the way teams work now is already slowing everything down. There’s also a belief that structured platforms remove flexibility, which isn’t always true. Often the opposite happens, clearer governance gives teams more room to focus on the work itself.
Building a Better Foundation
Reducing spreadsheet dependency doesn’t mean banning Excel. It means deciding where spreadsheets stop being helpful.
Platforms like myLaminin approach this from a governance perspective rather than a replacement mindset. myLaminin also automates many of the administrative parts of clinical trial management, reducing manual tracking and helping teams spend less time maintaining spreadsheets. Instead of forcing teams to abandon familiar tools, myLaminin helps organize research data, roles, and context so spreadsheets don’t end up carrying the weight of an entire trial.
The shift usually happens gradually. Teams start by moving higher-risk workflows into structured environments while still using spreadsheets where they make sense.
What Teams Learn When They Make the Change
Organizations that move away from spreadsheet-driven processes often notice the same thing first, less confusion.
Fewer duplicate files, clearer accountability, better visibility across teams and sites. None of it feels dramatic at first, but it changes how work flows day to day.
Over time those small improvements compound. Studies become easier to manage, collaboration feels steadier, less fragile.
Final Thoughts
Spreadsheets aren’t inherently dangerous. They become risky when they evolve into systems that were never meant to support regulated research.
Clinical trials are getting more complex, more collaborative and honestly a lot more data intensive than most teams expected. Relying on spreadsheets as the backbone of those processes adds pressure that builds slowly until it’s difficult to ignore.
Tools like myLaminin show that research teams don’t need to give up flexibility to gain structure. The real shift isn't about getting rid of spreadsheets, it's more about being honest about where they fit and where they don't really belong.
CTMS is not just project management software, it is the operational backbone of trusted, compliant, and secure clinical research.
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Jagdeep Saran (article author) is a myLaminin intern, and studying Honours Commerce at McMaster University.
