Transitioning From Research Lab to a Commercial Clinical Lab: LIMS vs LIS

Turning Diagnostic Innovation Into a Commercial Reality

Clinical research labs developing novel diagnostic assays eventually face a critical transition point: moving from research and development to real-world delivery of testing to patients.

Starting and scaling commercial operations means establishing systems for ordering, billing, data management, and provider connectivity, all while maintaining compliance and service expectations. The key to that transition is shifting from ad-hoc, research-focused LIMS to a clinical-grade Laboratory Information System (LIS) that can manage CLIA-compliant testing, client interactions, and growth.

The Growing Pains of Scaling from R&D to Clinical Operations

In the research phase, most labs rely on a mix of tools designed for internal experimentation — not for patient testing or external client management. These systems work well for assay development, data capture, and validation, but they provide no framework for running a commercial laboratory operation.

When a lab begins transitioning from R&D to clinical testing, the challenge begins with standing up the entire operational infrastructure needed to serve providers, manage compliance, and support revenue workflows.

Common early-stage data management systems:

• Spreadsheets, databases, or LIMS built for research
• Manual sample tracking and data entry
• Reports generated directly from raw instrument data
• Lack of connectivity with EHRs, ordering platforms, or billing tools
  
  

While a LIMS can record samples and experiments, it stops short of what’s required for commercialization. Labs entering the clinical phase often find themselves building workflows from scratch such as: creating ordering systems, configuring billing workflows, setting up to meet CLIA/CAP compliance, and attempting to retrofit basic data systems for external use.

‍

‍

‍

When challenges appear:
Once a lab begins serving external providers or patients, data management quickly increases in complexity.

• Research-focused LIMS lack the database structure to manage external ordering, billing, or patient data without complex setup.
• Providers can’t easily place or track orders.
• Integrations with EHR/EMR systems are difficult or impossible.
• Billing requires complex insurance workflows and ICD code management.
• Bespoke systems have trouble meeting CLIA/CAP compliance or long-term data retention standards.
  
  

Key takeaway:
R&D tools like LIMS handle experimental data, but offer no blueprint for clinical workflows A clinical LIS, by contrast, is purpose-built to help labs scale operations, attract providers, and deliver professional, compliant reports that drive confidence in their assay.

Building a Clinical-Ready Ordering Experience

Once assays are validated, providers need an easy way to order and receive results. The ordering experience directly impacts how quickly your test gains adoption.

Solutions to consider:

• Provider Ordering Portals: Web-based portals that include requisition forms, label printing, and order tracking.
• Standing Orders: Ideal for high-frequency clients (like clinics running weekly panels).
• EHR Integrations: Enable providers to order tests and receive results directly within their EMR using HL7 or FHIR interfaces.
  
  

Common pitfall:
Many labs underestimate the complexity of provider onboarding. Managing multiple client accounts, access levels, and test menus manually can overwhelm staff. A clinical LIS automates those steps — making the ordering experience as smooth as possible for providers and reducing friction to adoption.

‍

Implementing Billing and Reimbursement Workflows

When research becomes clinical testing, every sample becomes a billable event. Implementing proper billing workflows early prevents revenue leakage and compliance issues later.

Key components:

• ICD Code Management: Capture the correct medical necessity documentation with each order.
• Advanced Beneficiary Notices (ABN): Store signed patient documents securely in the LIS for compliance
• Billing Integrations: Export claims data directly to billing vendors such as via HL7 DFT messages or APIs.
• Automated Charge Capture: Ensure every completed test is automatically associated with a billing record.
  
  

Why it matters:
Billing workflows are often the most time-consuming systems to retrofit once clinical testing begins. Implementing an LIS with built-in billing capabilities can save months of rework and accelerate time to revenue.

‍

Integrating with EHR Systems

EHR integration is often the biggest hurdle when moving into clinical operations. Each provider uses a different system, some modern, others outdated. Yet all expect seamless order and result delivery.

What’s involved:

• HL7 or FHIR interfaces for orders/results
• Interface configuration via SFTP or API
• Validation cycles with provider IT teams
• Ongoing monitoring and maintenance to prevent downtime
  
  

Modern LIS platforms (like Dendi):

• Provide standardized HL7 and FHIR specifications with open API access
• Manage EHR connections through an in-house integration team
• Offer automated interface monitoring to minimize disruption
  
  

Outcome:
Streamlined provider onboarding and fewer errors in order/result transmission, allowing your lab to expand its clinical footprint faster.

‍

Why Labs Moving to Clinical Testing Need an LIS

As your lab scales, the LIS becomes the operational backbone connecting your people, instruments, and data in one cohesive workflow. A typical research LIMS might log tens of thousands of activities a month; a CLIA-certified lab running on a LIS can generate millions of audit records annually — every order, result, and edit must be traceable.

An LIS helps by:

• Centralizing all patient, order, and results data
• Managing permissions, audit trails, and role-based access for compliance
• Supporting EHR and billing integrations
• Generating professional, branded reports for providers
• Reducing manual entry and ensuring data consistency
  
  

Without it:
Labs encounter bottlenecks, reporting errors, and limited scalability which delay commercial adoption of their assays.

‍

The Dendi Approach

Dendi LIS was designed specifically for emerging diagnostic labs with commercialized novel assays. Built on modern, cloud-native architecture, Dendi helps labs transition smoothly from R&D to clinical operations with rapid deployment, capable integrations, and flexible reporting.

Key features:

• Provider ordering portals and EHR integrations
• Proprietary instrument interfacing platform for rapid setup and monitoring
• Custom report builder with assay-specific branding
• Billing workflows with ICD and payer integrations
• Agile software updates to support new assay launches
  
  

Dendi LIS acts as the operational backbone of labs to connect people, instruments, orders, and data while ensuring every action is traceable and compliant. The result is that your lab can move towards commercial adoption faster without rebuilding your data infrastructure as the lab scales.

If your lab is preparing to move from research to clinical testing, now is the time to establish the right foundation. Dendi LIS helps diagnostic innovators scale with confidence — from their first provider connection to full commercial operations.

Learn how Dendi LIS supports assay development labs → Schedule a Demo

‍