Adoption & Change in Clinical Operations: Why We Stay Stuck in Systems That Are Failing Us
If you walk into almost any small or mid-sized biotech right now and ask, “Where does the real picture of our trial live?”, you’ll get the same answer in a hundred different flavours:
“There’s a spreadsheet somewhere that has everything.”
It might be one workbook with ten tabs, or three workbooks with fifteen tabs. It might be colour-coded and immaculate, or a mess of frozen panes and hidden columns. It might have a polite name like “Study Overview” or an honest one like “Tracker_v29_Final_Updated_FINAL”.
But underneath the surface, the feeling is the same: we are running high-stakes clinical trials on fragile, invisible systems that everyone knows could crack at any moment.
This isn’t just a tooling problem. It’s an adoption and change problem: how smart, experienced people get trapped in the systems they built, and how they can get out.
1. “What If This Cell Is Wrong?” – The Unspoken Anxiety of Spreadsheet-Run Trials
Picture a typical cross-functional trial meeting in a small biotech.
- A CTA, a Study Manager, a Clinical Project Manager, maybe a Program Lead or ClinOps Director.
- A Chief Medical Officer or COO drops in and wants a clear answer: “Where are we really?”
- Quality Assurance is listening in, mentally mapping what they hear to what might eventually land in the TMF.
On the surface, everyone is “aligned”.
The PM shares their screen. A complex workbook appears. Tabs for sites, milestones, vendor deliverables, deviations, monitoring visits, risk logs. Conditional formatting bravely attempts to turn chaos into colour.
The conversation sounds organised:
- “Site 03 is a bit behind on screening.”
- “The CRO has confirmed the next monitoring visit.”
- “We’re on track for the protocol amendment sign-off.”
But underneath, there’s a tension no one names out loud:
“What if this cell is wrong?”
“Which tab is the real one?”
“Did we update this before or after that email?”
In the background:
- Juniors like CTAs do a lot of the manual updating but have little authority to challenge the system.
- Mid-level managers are juggling 20 parallel mini-projects within the trial. They’re so deep in the Excel Multiverse that stepping back to redesign the system feels impossible, or irresponsible.
- Seniors and C-suite want clean, simple answers for investors and governance boards. They are far removed from the trackers but deeply exposed to what happens if they’re wrong.
- QA looks at these uncontrolled files and quietly shudders. Their job is to ensure the regulatory record is robust, but the day-to-day reality rests on spreadsheets that weren’t designed to be systems of record at all.
Most teams don’t resist new tools because they’re lazy or change-averse. They resist because bandwidth is already gone; they are drowning in enablement work masquerading as progress. Updating trackers feels like doing the job.
And then there’s the pride.
Some managers have built intricate spreadsheet systems that are genuinely impressive. Those systems helped them get hired, promoted, and trusted. Over time, they become more than tools – they become identity.
The idea of “relinquishing control” of their spreadsheet is threatening, even when that spreadsheet is now version 29 and nobody is sure which tab is still accurate.
So we stay in the Excel Multiverse, powered by a quiet, constant fear:
“If this is wrong, it’s on me.”
2. “It’s Not a Tool, It’s a Prison” – Why Smart PMs Stay Stuck in the Systems They Built
When people complain about adoption and change, they usually blame tools:
- “We don’t have time to implement something new.”
- “I don’t see how this is any better than my spreadsheet.”
- “Smartsheet is just Excel online – why bother?”
But there’s a harder truth hiding underneath:
If every tool feels like “just another spreadsheet”, the problem isn’t the tools.
The problem is the prison you’ve built for yourself.
The pattern is familiar:
- A manager, often a capable and conscientious one, builds a clever spreadsheet system at the start of a trial.
- That system grows. Tabs multiply. Formulas get copied, tweaked, repurposed.
- The spreadsheet starts to define “how we do things here”. New joiners learn the system, not the principle behind it.
- The manager’s value becomes tied, silently, to their ability to maintain and interpret this increasingly complex file.
They become a prisoner of their own system – and then, over time, they learn to love their prison.
The narrative that creeps in is:
- “This is how I add value. I keep it all in my head and my sheet.”
- “If I let go of this, I lose control.”
- “If we change this, we risk delays – and I’ll be blamed.”
So when someone suggests a different way of working, the natural response isn’t curiosity, it’s defensiveness. Not because they’re stubborn, but because they’ve built a system that confuses enablement with progress.
“What’s more important to you: managing your spreadsheet, or getting that protocol amendment through in ASAP time?”
Until that question is faced honestly, no new tool – however good – will really land.
3. The Hidden Spreadsheet Tax – Time, Risk, and Opportunity You Don’t See on a Gantt Chart
Once we’re honest about the prison, we can talk about the bill.
This isn’t abstract. There’s a body of work on spreadsheet risk, knowledge-work inefficiency, and governance failures that all point in the same direction: spreadsheets are unfit for purpose as the primary system for running complex, regulated projects.
3.1 Error isn’t a possibility – it’s the baseline
Field audits of real operational spreadsheets show that errors are not a rare edge case – they are the norm. Powell and colleagues audited 50 operational spreadsheets and found errors in 0.9% to 1.8% of formula cells, depending on how errors were defined.[1]
That might sound small, until you multiply it across hundreds or thousands of formula cells in a typical project workbook. The probability that no formula is wrong drops fast as complexity grows – which is exactly what happens in trials.
Professional bodies summarise this bluntly. The Institute of Chartered Accountants in England and Wales (ICAEW) notes that a “common statistic” in the literature is that as many as 90% of spreadsheets contain a mistake.[2]
In a personal budget sheet, that’s annoying.
In the workbook that defines your trial milestones, vendor deliverables, and site status, it’s a structural risk.
Real-world disasters underline the point. Analyses of JPMorgan’s “London Whale” incident describe how a complex Value-at-Risk model was implemented in Excel, involved manual copy-paste, and contained formula issues that contributed to mis-stated risk and losses of around $6 billion.[3]
If a spreadsheet error can help erase billions in a bank, it can absolutely undermine the integrity of a “green” status report for a clinical trial.
When your operational truth lives in a multi-tab spreadsheet, the question is not whether there’s an error. It’s where, and how much damage it will do before you notice.
3.2 The admin gravity well – where the week actually goes
Then there’s the time tax.
Multiple studies of knowledge workers show that a large slice of the working week is spent searching for and preparing information, rather than acting on it. IDC and Forrester data, summarised in industry reports, suggest that employees may spend around 30% of their time just looking for data and information they need to do their jobs.[4][5]
APQC’s research on collaboration and information flow similarly finds that knowledge workers spend hours each week looking for, requesting, recreating, and duplicating information – adding up to roughly 20% or more of the workweek.[6]
Now map that onto clinical operations where:
- The “source of truth” for project status is scattered across multiple trackers.
- Different stakeholders keep their own slightly different versions.
- Every governance forum, steering committee, or internal review requires a fresh round of reconciliation.
For a mid-level Clinical PM or Study Manager, that means:
- Updating trackers after every call.
- Reconciling conflicting numbers between tabs and files.
- Chasing colleagues and vendors for “the latest version”.
- Rebuilding views for slide decks that instantly go out of date.
Ask them what they do for a living, and they’ll say, “I’m managing the trial.”
But if you baseline their calendar against this data, a non-trivial part of their week is going into maintaining the illusion of visibility, not moving the trial.
3.3 Compliance and QA: spreadsheets as shadow systems
From a QA and governance perspective, the problem is even sharper.
Risk and compliance specialists have been warning for years that spreadsheets make poor systems of record. Governance and GRC analyses highlight recurring concerns: spreadsheets are hard to manage at scale, prone to error, and typically lack a robust chain of evidence – with weak version control, fragile file security, and no reliable record of who changed what, when.[6][7]
ICAEW guidance on reviewing spreadsheets underscores that, unlike most transactional systems, spreadsheets generally do not maintain a comprehensive audit trail of changes, making it difficult to see who made which edits and to assess the reliability of calculated outputs.[2]
Vendor and project-management commentary in other industries echoes the same theme: spreadsheets lack strong role-based access control, are vulnerable to silent overwrites and corruption, and become opaque “shadow systems” when used to run critical processes over time.[6][7]
For a QA lead in a clinical trial, that translates into very concrete worries:
- You can’t reliably see who changed a key date or status and when.
- It’s unclear which version of a tracker was used to support a decision.
- You don’t have confidence that operational data flowing from trackers into the TMF is complete, accurate, and attributable.
In other words, the very tools being used to run the day-to-day trial create a shadow system that is misaligned with how regulators expect critical information to be controlled and evidenced.
So the hidden spreadsheet tax looks like this:
- Error as the baseline, not the exception, in the system that defines “current reality”.[1][2]
- 20–30% of knowledge-worker time burnt on finding, reconciling, and preparing information before any real project work happens.[4][5][6]
- Systemic blind spots for QA and compliance, because spreadsheets aren’t built to be traceable, access-controlled systems of record.[2][6][7]
None of that shows up on a Gantt chart. All of it shows up eventually as delays, rework, inspection pain, and burnout.
If this is resonating uncomfortably strongly and you’ve already heard enough, you don’t have to wait for the punchline. You can join the TrialTrack waitlist now and be first in line when we open access to our second-brain workspace for clinical teams.
4. “If This Slide Is Wrong, It’s On Me” – The Human Cost of Spreadsheet Loyalty
Stats are one thing. But adoption and change rarely hinge on stats alone. They hinge on how people feel.
So let’s zoom in on a single, composite week for a mid-level Clinical Project Manager.
Monday
Three emails arrive before 9 a.m.:
- QA: “We need a clean, current view of study status before the inspection-readiness meeting on Friday.”
- VP ClinOps: “Can you send me a one-pager on where we really are?”
- CTA: “Just flagging some differences between enrolment numbers in Tracker_v23 and Tracker_v29_Final_Updated.”
She already knows what her week will be: not managing the trial, but reconciling its representations.
Tuesday
She’s on a Teams call, screen-sharing a complex workbook. Someone spots that IP shipment dates on one tab don’t match the dates on another. The air goes out of the room for a moment.
QA asks, carefully:
“If we can’t tell which version is correct or who changed what, how do we stand behind this in front of an inspector?”
No one says, “Because it’s Excel and we’re making it up as we go along,” but everyone knows that’s part of the answer.
Wednesday–Thursday
The CTA, keen and conscientious, recently spent more than two weeks rebuilding “a tracker for the trackers” – consolidating three workbooks and over a dozen tabs into something coherent. During that time, the core purpose of their role – supporting the CRO, managing referrals for rare disease patients – is pushed to the side.
The PM’s internal monologue loops endlessly:
If I miss one formula, that slide on Friday will be wrong.
If the slide is wrong, leadership will lose trust.
If they lose trust, there’s no chance we get budget for something better than this.
At 10:30 p.m. on Thursday, someone cracks the only joke they have left:
“I’ve got a tracker for my trackers now – we’re very advanced.”
Everyone laughs, because the alternative is admitting how exposed they feel.
Friday
The one-pager is done. The meeting happens. The status is officially “amber trending green.” The trial limps on.
But the unseen cost is real:
- Late nights and cumulative stress.
- Quiet fear that the next discrepancy could look like personal incompetence, not systemic failure.
- Talented CTAs and PMs spending their best energy cleaning up data, not moving the project forward.
That’s the emotional core of the adoption problem:
People feel they will be judged on the perfection of a system that was never designed to be perfect – and they blame themselves, not the system, when it cracks.
5. From Tracker Curator to Control Tower – How Advanced Teams Actually Run Trials
The good news is that some teams are already escaping this pattern.
Not because they are smarter or better funded, but because they’ve made a conscious shift in how they see their role and how they treat information.
The real change is not “Excel to Solution or Software Product”. It’s:
From spreadsheet curator to control tower.
From “everything lives in my personal system”
to “our information lives in a shared second brain that has everyone’s back.”
In this new model, a modern Clinical PM behaves differently:
- They no longer measure their value by how perfectly they maintain trackers.
- They measure their value by how effectively they make decisions, orchestrate action, and move the trial.
Concretely, the shift looks like this:
- From: “I prove my value by curating and maintaining spreadsheets.”
To: “I prove my value by making decisions and moving the trial forward.” - From: “Information lives in my personal system that only I understand.”
To: “Information lives in a shared second brain that has my back and my team’s back.” - From: “I record things after the fact.”
To: “I conduct progress like an airport control tower – I can see what’s in the air, what’s landing, and what’s delayed in real time.” - From: “I spend my week protecting fragile trackers from corruption.”
To: “I don’t worry about the quality of my data because it’s secure, traceable, and access-managed by design.” - From: “I’m the gatekeeper of status.”
To: “I’m the orchestrator of action – the system handles status, alerts, and nudges so I can focus on issues, sites, and people.”
This isn’t about handing your brain over to software. It’s about stopping the addiction to admin and giving your brain a proper partner.
Psychologists actually have a name for this idea of a “second brain”: cognitive offloading – using external systems to carry part of the mental load so your working memory isn’t doing all the heavy lifting.
In a 2021 paper, Grinschgl and colleagues showed that when people offload information to an external aid, their performance on demanding tasks improves, even though they remember less detail later.[8]
Meyerhoff et al. (2021) make a similar point in a study of everyday-type tasks: the cognitive load of many real-life activities exceeds the limits of short-term memory, and one effective strategy to cope is to offload – using notes, reminders, or other external supports instead of trying to hold everything in mind.[9]
A Phase II oncology study with multiple vendors, sites, and protocol changes is not a “remember three things” task. It’s textbook cognitive overload. Treating your trial system as a deliberate second brain isn’t laziness – it’s good cognitive hygiene.
In this second-brain model:
- The system does the enablement work: remembering dependencies, nudging people when something slips, maintaining history.
- QA gains peace of mind because operational information is traceable and permissioned, not floating in uncontrolled files.
- CTAs get pulled into more meaningful work – coordination, problem-solving, learning – instead of being sentenced to tracker reconstruction.
- PMs stop being the single point of failure and start being what they were hired to be: leaders of progress, not guardians of Excel.
6. Meet TrialTrack – The Second Brain That Makes You the Person Everyone Trusts
If the new mindset is:
- “I’m not a curator of trackers; I’m the control tower.”
- “My value is in decisions and progress, not in V29_Final_Updated.”
- “My second brain should be reliable, compliant, and shareable.”
…then the natural question is:
“How do we get there without losing six months to another tool project?”
This is where TrialTrack comes in.
6.1 The easy path out of spreadsheet prison
Most teams are afraid of change because they’ve been burned before:
- Months spent on RFPs and vendor demos.
- Heavy platforms that need a small army to implement.
- Generic tools that claim to do everything and end up feeling like “Excel on steroids”.
TrialTrack is deliberately different. It’s built specifically for clinical trial project management, but it’s designed to be lightweight to adopt:
- You can sign up and start on the same day – no six-month selection saga.
- The interface is intuitive enough that you can use it without training. Training videos and chat support are there, but you don’t need a workshop just to add tasks or see study status.
- The compliance story is open and transparent. Information about validation, security, and how TrialTrack fits into a GCP-aligned environment is readily available and kept up to date, not buried in a PDF only Procurement sees.
In other words, the perceived loss of time that usually kills adoption – “we’ll have to stop everything to roll this out” – is removed.
You don’t have to pause the trial to change how you manage it.
6.2 A second brain that actually behaves like an assistant
Where your spreadsheet demands constant maintenance, TrialTrack behaves like a trustworthy assistant:
- It becomes the single shared place where tasks, responsibilities, and vendor relationships live – across sites, vendors, and internal teams.
- It tracks what you put in and structures it in a way that lets you see the “current situation” of the project at a glance.
- It warns you when something is slipping, instead of waiting for you to go hunting for red flags.
- It comes with user management and audit trails built in, so QA doesn’t have to be afraid of “who changed what” when operational information flows into the TMF.
This is exactly what cognitive offloading research suggests we should be doing in complex work. When we move information out of our heads and into a reliable external system, we reduce the load on working memory and improve performance on demanding tasks.[8][9]
In other words, the more of the admin you can safely hand to your second brain, the more of your own capacity you can spend on judgment, escalation, and decision-making.
Running a multi-site trial with overlapping milestones, vendor contracts, and protocol amendments fits that description perfectly. A tool like TrialTrack is not just “another app” – it’s the intentional offloading target for your operational brain.
Compare that to the spreadsheet you hacked together in week two of the trial:
- Does it tell you who changed a critical date last Wednesday?
- Does it nudge the right person when a site activation action is overdue?
- Does it give QA enough confidence to let that information be treated as part of the regulatory record?
Or compare it with generic project tools:
- Do they really understand the difference between a protocol amendment and a site close-out, or are they just boxes and dates?
- Do they come with a clear, clinical-ops mindset baked in, or are you fighting the tool to make it behave like a trial system?
TrialTrack is designed so that when people look to you for answers – leadership, QA, sites, vendors – you can show them:
- A clear, honest picture of where the trial really is.
- A traceable history of how you got there.
- A confident path forward, not a scramble through tabs.
6.3 Change at the speed of a credit card
One of the most powerful aspects of TrialTrack for adoption and change is how easy it is to start small and grow:
- A single user who just wants to stop drowning in trackers will be able to use a free, single-user account to run their own second brain.
- When they’re ready to bring in colleagues, they can start a 14-day free trial of the team workspace and move onto a straightforward subscription – no massive up-front commitment, no capital project.
- All it needs is a credit card, not a committee.
That means:
- The CTA who spent two weeks rebuilding three workbooks can quietly move their world into something better.
- The PM who’s tired of being the status gatekeeper can start living like a control tower.
- The QA lead who is nervous about shadow systems can see, in practice, what a traceable, access-managed second brain looks like.
And when others see the difference – cleaner reviews, fewer surprises, calmer inspection prep – you become the person who brought order to the chaos. Not by shouting for budget, but by quietly proving there’s a better way.
Bringing It All Together
Adoption and change in clinical trial operations isn’t really about Excel versus tools.
It’s about:
- Recognising that many of us have become prisoners of systems we built.
- Facing the hidden tax those systems impose in time, risk, and emotional burnout.
- Shifting from enablement work (curating trackers) to real progress (moving the trial).
- Giving ourselves a second brain that behaves like a trustworthy assistant, not a temperamental file.
When you make that shift, tools like TrialTrack stop being “another thing to adopt” and start being what they always should have been:
A simple, reliable way to see reality together,
so you can spend your time changing it.
Join the TrialTrack Waitlist
If you recognise yourself in the Excel Multiverse – the late nights, the “tracker for the trackers”, the quiet fear that one broken formula will blow up your next review – then you’re exactly who we’re building TrialTrack for.
Before launch, access is limited – but you can put your hand up now:
Be among the first to step out of spreadsheet prison and into a second-brain workspace built for clinical trials.
(After launch, you can swap this final section’s last line to something like: “Sign up for your free single-user account and start running your trial like a control tower, not a curator of V29_Final_Updated.”)
References
- Powell, S. G., Lawson, B., & Baker, K. R. (2009).Impact of Errors in Operational Spreadsheets.
ArXiv preprint and subsequent journal publication; field audits of 50 operational spreadsheets found errors in 0.8–1.8% of formula cells. - ICAEW (2021–2022).How to Review a Spreadsheet – Reduce the risk that your spreadsheet gives you the wrong answer.
ICAEW Technology / Excel Community thought-leadership report noting that a common statistic is that “as many as 90% of spreadsheets contain a mistake.” - Groenfeldt, T. (2013). Solutions To Spreadsheet Risk Post JPM’s London Whale. Forbes.
- IDC (often cited as “2.5 hours per day searching for information”).
IDC research on knowledge workers’ time spent searching for information (approx. 30% of the workday).- Secondary summary (Cottrill Research): Workers Spend Too Much Time Searching for Information – https://www.cottrillresearch.com/workers-spend-much-time-searching-information/
- Forrester (for Airtable / CDP Institute).Knowledge Workers Lose 30% of Time Looking for Data.
Discusses survey findings that knowledge workers lose around 30% of their time looking for data.- CDP Institute summary: https://cdpinstitute.org/knowledgebase/knowledge-workers-lose-30-of-time-looking-for-data/
- APQC.Knowledge Workers: Productivity and Knowledge Management (various articles and surveys).
Reports that knowledge workers spend ~8.2 hours/week (≈20% of time) looking for, requesting, recreating, and duplicating information. - Riskonnect.
- How Spreadsheets Hurt Governance, Risk and Compliance – highlights spreadsheets’ lack of audit trails, version control, and suitability for GRC.
- Why Managing Risk with Spreadsheets is Risky – discusses spreadsheet limitations for risk management.
- Spreadsheet Software vs Risk Management Software: A Side-by-Side Comparison.
- Oracle (2023).10 Common Spreadsheet Risks and Solutions for Businesses. Oracle Business Analytics.
Outlines key spreadsheet risks (errors, outdated data, security/compliance issues, scalability limits).- UK / Analytics page: https://www.oracle.com/uk/analytics/spreadsheet-risks/
- Grinschgl, S., Papenmeier, F., & Meyerhoff, H. S. (2021). Consequences of cognitive offloading: Boosting performance but diminishing memory. Quarterly Journal of Experimental Psychology, 74(9), 1477–1496.
Shows that offloading information to external supports improves performance on demanding tasks while reducing later memory for details.- Open-access full text (PMC): https://pmc.ncbi.nlm.nih.gov/articles/PMC8358584/
- Meyerhoff, H. S., Grinschgl, S., Papenmeier, F., & Gilbert, S. J. (2021). Individual differences in cognitive offloading: A comparison of intention offloading, pattern copy, and short-term memory capacity. Cognitive Research: Principles and Implications, 6(34).
Discusses cognitive offloading as a strategy when short-term memory limits are exceeded, and how people rely on external aids to manage information load.
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