Electronic Clinical Outcome Assessment (eCOA) Services

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eCOA for Clinical Trials

Electronic Clinical Outcome Assessment (eCOA) systems are a technology that enables the capture of clinical trial data directly from patients, clinicians, and observers. This umbrella term covers any digital means of documenting patients’ condition, symptoms, and treatment effects. Electronic Patient-Reported Outcomes (ePRO) are a subset of eCOA, and represent the data collected directly from patients without third-party amendment or interpretation. ePROs are often conducted remotely on devices such as tablets, computers, and smartphones, whereas eCOA may also be captured in-person and encompasses clinician assessments and medical devices.

In many clinical trials, eCOAs are a critical component because they provide valuable insights into a patient’s disease progression and overall well-being. Decades ago, patient reported outcomes (PROs) were collected using paper-based methods, which were liable to loss/destruction, transcription errors, and data inconsistency. Today’s eCOA innovations allow patients to complete questionnaires electronically, either on their own devices or through a dedicated study portal. Patients can complete eCOA assessments from their own homes, and the data can be transmitted securely to the clinical trial database. 

3 Key Benefits of eCOA

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Upgrade End User Experience

With more visual design tools, reference material embedding, and clearer instructions, Sponsors can leverage eCOA to improve patient engagement and adherence to...

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Upgrade End User Experience

With more visual design tools, reference material embedding, and clearer instructions, Sponsors can leverage eCOA to improve patient engagement and adherence to treatments. Additionally, by providing the flexibility of data completion from anywhere, decentralized clinical trials are made possible.

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Analyze Data in Real-Time

Compared to traditional methods, digital assessments play a larger role in decentralized and hybrid trials. Data quality and streamlined collection become especially...

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Analyze Data in Real-Time

Compared to traditional methods, digital assessments play a larger role in decentralized and hybrid trials. Data quality and streamlined collection become especially paramount, as clinicians do not fully control the study environment. Real-time data capture is particularly helpful in this context as it enables immediate monitoring and tracking of success criteria; furthermore, site staff can identify safety issues and trends earlier.

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Comply with Regulations and Quality Standards

With audit trails, patient-specific credentials, and secured storage, electronic data capture ensures compliance with regulations such as FDA 21 CFR Part...

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Comply with Regulations and Quality Standards

With audit trails, patient-specific credentials, and secured storage, electronic data capture ensures compliance with regulations such as FDA 21 CFR Part 11. Furthermore, logic checks and rules can be built into forms to standardize data upon entry, minimizing the number of quality checks and verification needed throughout a study.

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Key Considerations for eCOA Implementation

Build Time

Standard eCOA development requires a series of steps, including licensing, build, image approval, UAT, IRB/EC submissions, and deployment. This process may take 3-4 months depending on the complexity of your study and the translations required.

Vendor Expertise

Choose an experienced vendor who understands your study’s unique requirements, supports all required languages, and provides expert guidance. ProPharma specializes in vendor assessment, guiding your organization through RFX and system demos to select a fit-for-purpose system.

Stakeholder Involvement

Identify relevant stakeholders and capture the patients’ and caregivers’ voice early during the implementation to ensure your eCOA solution fosters patient engagement and reduces sites’ administrative burden.

Interoperability

To reduce duplicative data entry, Sponsors may require data transfer to EDC and information flow to RTSM. Assess whether your eCOA vendor offers published APIs or direct integrations.

5 Important Factors in Selecting an eCOA 

Before contacting vendors, it’s important to collect the following information about your organization: 
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Business Requirements

Business Requirements

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Budget

Budget

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Timeline

Timeline

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Complexity

Complexity

Submissions

Compliance

Compliance

Business Requirements

eCOA implementations are not one-size-fits-all. Determine which features are nice-to-have, and which ones are critical for your organization. For example, if a library of approved and reusable forms is a requirement, confirm that potential vendors will support those needs.

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Budget

eCOA systems should be viewed as an investment. Licensing, system support, and subscription fees may be continuing costs that should be compared against your department’s budget. Consider how pricing may change as you build more studies and add system users. 

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Timeline

Consider each vendor’s proposed implementation timeline against the time constraints of your company. If your study’s inclusion criteria include patient studies and enrollment is starting in eight weeks, narrow consideration down to vendors who can complete the project by that timeframe. 

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Complexity

Purchasing an eCOA is an investment not only of money, but also of time and effort. How much training will your staff need to learn the system properly, and do you have resources in-house to build a dedicated support team? Additionally, factor in your team’s adaptability and buy-in when selecting a particular solution. 

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Compliance

Does the eCOA software meet all standards imposed by IRBs, HIPAA, GDPR, ALCOA, and 21 CFR Part 11? Assess the vendor’s agility in releasing new features to support evolving regulations. 

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ProPharma: Your Organization’s Preferred Partner for eCOA Selection & Implementation

ProPharma’s R&D Technology team understands the criticality of selecting the right electronic clinical outcome assessment and excels in aligning your companies’ needs with regulations and system best practices. Our comprehensive approach and expert knowledge ensure that your organization is set up for long-term success.   Our team also has extensive experience in these additional areas: 

Service Category

How We Can Help

Strategy & Business Process Optimization

  • eCOA
  • Roadmap Development

Clinical Research Solutions

  • Staff Augmentation

Implementation Support

  • Project Management
  • Configuration & API Integrations (EDC, CTMS)
  • Controlled Document Creation (SOPs and Job Aids)
  • User Administration & Training
  • Change Management

Validation

  • eCOA Validation Coordination
  • User Acceptance Test Scripts

Managed Services

  • System Administration
  • Release Management
  • System Optimization

Expert eCOA Implementation & Management

If you are interested in implementing or optimizing your eCOA, ProPharma's R&D Technology team comprises experienced consultants who can advise your digital transformation. If you are interested in partnering with ProPharma on any of the services above, contact us via the form below. We look forward to working with you!

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