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.

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.

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.

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.