Clinical research sites rarely fall behind on trial milestones because of a single failure. More often, delays build slowly, day by day, through friction that is hard to see, hard to measure, and easy to normalize. The number one reason why clinical research sites miss trial milestones is not staffing, motivation, expertise, or even protocol complexity. It’s operational drag caused by fragmented research workflows.
When trial milestones slip, the same explanations tend to surface:
- Staffing shortages
- Increasing protocol complexity
- Regulatory burden
- Sponsor-driven timelines
All of these factors matter. However, none of them are usually the root cause.
Most clinical research sites, AMCs, hospitals, and health systems are staffed by experienced coordinators and operations teams working at full capacity. The real issue isn’t how hard teams are working. It’s how much invisible, non-value-added work is required to keep systems aligned.
Where Clinical Trial Milestones Start to Slip
In large academic medical centers and health systems, this fragmentation is often compounded by departmental silos, shared services, and parallel technology stacks across service lines.
- Protocols and amendments stored in shared drives or SharePoint
- Regulatory documents managed in separate eReg/eISF or file systems
- Source data captured in eSource systems or on paper
- Study data re-entered into electronic data capture (EDC) systems
- Oversight tracked through spreadsheets, email, and meetings
Each system may function as intended. However, the problem is that no single system owns the workflow from end to end. As a result, people become the integration layer. Every handoff introduces friction and every workaround adds drag.
The Very Real Cost of Duplicate Data Entry in Clinical Trials
Consider what happens every time a coordinator captures the same data more than once:
- Data is entered into eSource
- The same data is re-entered into EDC
- That data is then explained, verified, and reconciled during monitoring
This workflow is still far more common than many organizations realize. According to the 2025 RealTime Reports: eSource ROI Survey, 72% of clinical research sites report manually transcribing data from eSource into EDC, and 68% report discrepancies caused by manual transcription.
On the surface, this may feel like a routine part of trial execution. In reality, it introduces compounding inefficiencies at every stage of the study lifecycle.
Duplicate data entry doesn’t just consume time. It introduces operational drag that leads to:
- Lost coordinator hours that could be spent on patients, protocols, or startup activities
- Increased risk of transcription errors and downstream data discrepancies
- Slower monitoring cycles and longer query resolution timelines
- Growing staff fatigue as teams absorb repetitive, low-value work
Across multiple trials and sponsors, these inefficiencies compound, making missed milestones inevitable even in high-performing sites.
Why Integration Alone Doesn’t Prevent Trial Delays
Many organizations attempt to solve milestone delays by adding integrations, typically point-to-point connections designed to move data between systems rather than redesign how work gets done:
- CTMS connected to EHR or EMR systems
- Billing systems tied into finance platforms
- Reporting tools layered on top of existing systems
Yes, integration improves data exchange. But integration alone does not redesign workflows. As long as teams are required to reconcile data, explain work across systems, and rely on power users to keep studies moving, operational drag remains.
Connecting systems and orchestrating workflows are not the same thing. Remember, integration enables data exchange. Workflow design determines performance.
How High-Performing Clinical Research Sites Stay on Track
Sites that consistently meet trial milestones don’t necessarily use more technology. They operate with less fragmentation.
Instead of asking: “How can we track this better?”
They ask: “Why does this work require so many handoffs?”
High-performing sites focus on:
- Leveraging centralized, integrated eClinical technology for trial award, start-up, and execution
- Designing workflows where data moves forward once
- Reducing manual reconciliation and duplicate entry
- Preserving institutional knowledge in standardized templates
- Giving leadership real-time visibility into trial execution
Altogether, this strategic approach leads to fewer surprises and fewer missed milestones.
The Takeaway
More AMCs, health systems, and hospitals are stepping back to evaluate how workflow design, data flow, and operational visibility impact trial execution, not just which tools they use. That conversation is already reshaping how leading organizations approach performance.
For teams conducting site-based clinical trials, delays happen:
- One handoff at a time
- One workaround at a time
- One reconciliation at a time
Sites that stay on track are removing friction from how research operates. Thinking about how this applies to your site? Talk to an expert to explore where hidden inefficiencies may be slowing execution and how to address them.
Frequently Asked Questions
Q: Why do clinical research sites miss trial milestones even with experienced staff?
A: Clinical research sites often miss trial milestones not because of staffing shortages or lack of expertise, but because of fragmented workflows. When work is spread across disconnected systems, teams spend significant time reconciling data, managing handoffs, and performing repetitive administrative tasks. This operational drag reduces available capacity and slows execution, even in well-staffed, high-performing organizations.
Q: What is operational drag in clinical trial execution?
A: Operational drag is the cumulative friction created by fragmented workflows in clinical trial operations. It occurs when teams rely on disconnected systems, manual data entry, repeated reconciliation, and informal workarounds to move studies forward. Over time, these inefficiencies consume staff capacity, introduce risk, and delay trial milestones—particularly in complex environments like academic medical centers and health systems.
Q: Why doesn’t adding more system integrations prevent trial delays?
A: System integrations improve data exchange between platforms, but they do not redesign how workflows end to end. Even in integrated environments, teams often must validate, explain, and reconcile information across systems. Without workflow orchestration, manual handoffs and reconciliation persist, allowing operational drag to remain despite increased connectivity.
Q: What is the difference between integration and workflow orchestration in clinical research?
A: Integration connects systems so data can move between them. Workflow orchestration designs how work progresses from one step to the next across people, systems, and processes. While integration enables data exchange, workflow orchestration determines operational efficiency and performance. Clinical trial execution improves only when workflows are intentionally designed end to end.
Q: Are these challenges more common in academic medical centers, hospitals, and health systems?
A: Yes. Academic medical centers, hospitals, and health systems often manage multiple departments, service lines, and parallel technology stacks. While this scale enables more research, it also increases fragmentation. Without centralized workflows and real-time visibility, operational drag becomes more pronounced, making milestone management more difficult.
Q: What do high-performing clinical research sites do differently?
A: High-performing sites focus on reducing fragmentation rather than adding more tools. They design workflows where data moves forward once, minimize manual reconciliation, standardize processes through templates, and provide leadership with real-time visibility into trial execution. This approach helps protect milestones and improve predictability across studies.
Q: Why does operational drag in clinical trials matter at the enterprise level?
A: At the enterprise level, operational drag reduces site capacity, delays decision-making, and limits leadership visibility across trial portfolios. Over time, it affects study timelines, sponsor relationships, and an organization’s ability to scale research efficiently and sustainably.