Operational Risk in Clinical Research: What Leaders Don’t See Until It’s Too Late

This brief is intended to help AMC, hospital, and health system leaders reframe how operational risk shows up in modern research environments.  

Most clinical research leaders track budgets, enrollment, timelines, and compliance closely. Yet one of the most expensive operational costs in research rarely shows up anywhere formal. It doesn’t appear in licensing. It doesn’t appear in budgets. 

It shows up in people. 

It shows up in the invisible work required to keep disconnected systems, workflows, and teams moving in sync. 

Where the Work Actually Lives

In most academic medical centers, hospitals, and health systems, clinical research work is spread across systems that were never designed to operate as one: 

  • Regulatory documents live in SharePoint 
  • Source data lives in a homegrown system 
  • Study data must be re-entered into EDC 
  • Oversight lives in spreadsheets, email threads, and meetings 

None of these tools are inherently wrong. The problem is that no single system owns the workflow from end to end. So, people fill the gaps. 

The Cost No One Budgets For

Every handoff introduces friction. Every workaround adds drag. For example, when a coordinator: 

  • Enters data in eSource 
  • Re-enters that same data into EDC 
  • Explains it again during monitoring 

Over time, this redundancy shows up as: 

  • Slower study execution 
  • Increased reconciliation and rework 
  • Higher error risk at handoffs 
  • Burnout among coordinators and operations staff 

The work gets done, but at a growing human cost. 

Why This Became the Norm

Most CTMS platforms were only built to: 

  • Track studies 
  • Support compliance 
  • Store data 

Legacy CTMS platforms and disparate solutions were not built to run modern research operations. 

Clinical research has grown more complex — more studies, more systems, more compliance pressure — yet the operating model stayed largely the same. The result is an environment where: 

  • Success depends on power users 
  • Institutional knowledge lives in people and PDFs 
  • Leadership visibility arrives after issues surface 

This works. Until scale, turnover, or complexity exposes the cracks. 

What Changes With an eClinical Command Center?

More advanced institutions are beginning to operate differently. They are redesigning workflows so: 

  • Workflows are visible end to end 
  • Teams spend less time reconciling and more time executing 
  • Leaders see operational risk as it forms, not weeks later 

This shift isn’t about adding another tool. It’s about establishing a centralized operating layer.  

SOMS is a unified Site Operations Management System, a centralized eClinical command center. When clinical trial site operations are designed as a cohesive system rather than a collection of tools: 

  • Duplicate data entry decreases 
  • Manual reconciliation fades into the background 
  • Institutional knowledge is preserved in workflows 

The result? 

  • More resilient operations at scale 
  • Stronger trial transparency 
  • Greater staff retention 

A Different Kind of Question

Many clinical research leaders are beginning to ask different questions: 

  • How much siloed or manual work is acceptable? 
  • Do we have a single, real-time source of truth for trial status across departments and teams? 
  • How early do we actually see risk across our trials? 

If those questions are already surfacing internally, it’s time to reduce the chaos. 

Talk with an expert to compare how leaders across AMCS, hospitals, and health systems are rethinking how operations work at scale. 

About RealTime eClinical Solutions

RealTime eClinical Solutions is redefining the operational backbone of site-based clinical trials with its comprehensive eClinical platform, a unified Site Operations Management System (SOMS) — connecting CTMS, Devana, eSource, eReg/eISF, participant engagement, payments, and analytics into one integrated ecosystem for modern clinical trial site operations. The platform extends visibility to sponsors and CROs with TrialAlign, an advanced site selection, feasibility, and performance analytics platform. Trusted by industry leaders worldwide, RealTime helps the organizations behind every trial work faster, smarter, and together.