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Safira eClinical Consulting

We offer valuable support and guidance to help Sponsor Clinical Research teams make good decisions to select the best technology and enhance their clinical trial processes.

Read our latest UAT blog post on User Acceptance Testing.

Let us start with the conclusion:

The Sponsor is ultimately responsible for User Acceptance Testing (UAT) of the final system and should do conduct an independent UAT.

There seems to be some confusion about what UAT is in the context of the configuration of an eCOA solution for a clinical trial.

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Developing a Robust Data Monitoring Plan

Data monitoring in clinical research begins with a strategic plan that outlines the entire data lifecycle—from collection and storage to analysis and reporting. This plan is crucial and should be established before the study commences to ensure clarity and consensus among all stakeholders. A comprehensive data monitoring plan not only sets the groundwork for how data will be handled but also defines the timelines and responsibilities, ensuring that every piece of data collected contributes meaningfully to the study’s objectives.

License Management in Clinical Trials

License management in clinical trials is crucial for ensuring the timely and compliant use of questionnaires and other licensed materials. Managing these licenses effectively prevents study delays, legal issues, and financial liabilities. As part of the preparatory phase, sponsors must secure appropriate licenses before patient enrollment begins, particularly when electronic implementations are involved.

Improve patient reported outcome data collection by streamlining documentation with proper eCOA training for researchers, site staff and patients.

eCOA, or electronic clinical outcome assessments, includes:

  • Patient-Reported Outcomes (PRO)
  • Clinician-Reported Outcomes (ClinRO)
  • Observer-Reported Outcomes (ObsRO)
  • Performance Outcomes (PerfO).

Implement Structured Change Management for Success

Change management is crucial in clinical trials to successfully adopt new technologies, processes, and procedures. The dynamic nature of clinical research demands constant adaptation to new findings, regulatory requirements, and technological advancements. Safira understands that while change is necessary, it can disrupt operations without a proper management plan. Our structured approach ensures that transitions are managed smoothly, minimizing impact and maximizing adaptation speed across your operations.

Improve patient reported outcome data collection by streamlining documentation with proper eCOA training for researchers, site staff and patients

eCOA, or electronic clinical outcome assessments, includes:

  • Patient-Reported Outcomes (PRO)
  • Clinician-Reported Outcomes (ClinRO)
  • Observer-Reported Outcomes (ObsRO)
  • Performance Outcomes (PerfO)

Recruiting Clinical Trial Participants Where They Are

Safira can help you leverage social media platforms as part of a greater strategy to improve efficiency, reduce time and budget and improve diversity for your trial recruiting initiatives.

 

Social Intelligence Report: Patients & Clinical Trials in the U.S. ebook

Safira’s Center for Social & Digital Excellence recently completed a social intelligence report looking at the trends in social conversations from patients and caregivers regarding their feelings and drivers related to clinical trials.

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Revolutionize your clinical research with eCOA

eCOA – the advanced electronic data collection system that streamlines trials, enhances patient compliance, and delivers high-quality, real-time data while ensuring patient privacy and regulatory compliance.

Enhanced Patient Understanding

Empower your clinical trials with eConsent – a streamlined, digital solution for informed consent that enhances patient understanding, boosts efficiency, and reduces administrative hassle, while ensuring regulatory compliance and accessibility for all.

Randomization & Trial Supply Management

Optimize your clinical trials with RTSM – a comprehensive system that streamlines participant randomization, treatment assignment, and trial supply management for a safe, efficient, and cost-effective research experience.

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New Condensed Best Practices Released for ePRO Implementation and Migration

08th, July 2025 | Uncategorized

The Electronic Clinical Outcome Assessment (eCOA) Consortium, under the umbrella of the Critical Path Institute, has released a condensed version of the best practices for the electronic implementation and migration of Patient-Reported Outcome (PRO) measures. This version, formally unveiled at the UK PROMS Conference on June 19, is based on the full publication by Mowlem et al. (2024) in Value in Health and is now available to the clinical research community in a more accessible and actionable format.


Why This Matters

Electronic PRO (ePRO) systems are critical to modern clinical research. Yet, successful implementation depends on more than just digitizing a form. Proper ePRO deployment requires attention to usability, compliance, and data integrity—especially when migrating validated instruments from paper to digital environments.

The condensed guide helps trial sponsors, CROs, vendors, and regulators quickly verify that key implementation standards are met without needing to parse through the full academic paper.


What’s Inside the Condensed Guide?

The guide organizes best practices into three main categories:

1. System Functionality Best Practices

  • Provide clear on-device training.
  • Avoid pre-filled answers and auto-advancement.
  • Allow backward navigation and final review before submission.
  • Ensure consistency in navigation and device orientation.
  • Include progress indicators to reduce survey fatigue.

2. Migration Best Practices

  • Comply with licensing and copyright from the measure owner.
  • Retain original content, formatting, and response orders.
  • Use single-item screens and self-contained items for clarity.
  • Ensure equal hit spots and font consistency across devices.
  • Avoid free-text input when possible to minimize variance.

3. Response Scale Implementation

Tailored approaches are recommended for common scales:

  • Verbal Rating Scales (VRS)
  • Numeric Rating Scales (NRS)
  • Visual Analog Scales (VAS)

Each requires specific formatting considerations to ensure usability and comparability across screen-based devices.


Built for Real-World Use

What makes this condensed version particularly valuable is its usability. It distills the critical insights from 15+ pages of academic discussion into a working reference that teams can apply during planning, development, and validation stages. It even references helpful flowcharts and examples in the original 2024 publication for deeper guidance.


Final Thoughts

This release marks another step forward in advancing patient-centered, digital-ready research practices. As ePRO continues to grow in adoption, tools like this ensure that patient voice remains both measurable and meaningful—without compromising data quality or compliance.

📘 Download the condensed best practices now to align your ePRO efforts with the gold standard in implementation and migration.

Curious about ePRO implementation? We literally wrote the book! Click the image below to get the book now. All proceeds from the sale of Electronic Patient-Reported Outcome Measures go to charity. So, why not buy two?

Patient-Reported Outcome Measures

Kayci Becker

Get The Definitive Guide to ePRO And Give Back

Get The Definitive Guide to ePRO And Give Back

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