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A Clinical Outcome Assessment (COA) is a measure that describes or reflects how a patient feels, functions, or survives. Types of COAs include:

• Patient Reported Outcome (PRO) - A measurement that comes directly from the patient
• Clinician Reported Outcome (ClinRO) - An assessment performed by a trained medical professional
• Observer Reported Outcome (ObsRO) - An assessment performed by an observer (i.e., a non-clinician, such as a teacher or caregiver)
• Performance Rated Outcome (PerfO) - A measurement based on a task(s) performed by a patient

^{Source: https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions#COADefinition}

An electronic Clinical Outcome Assessment (eCOA) is a method of capturing patient experience data electronically in clinical trials and real-world studies.

eCOA platforms intelligently automate capturing a patient's experiences through robust and reliable electronic measures, providing real-time insights that inform trial progress and demonstrate results.

These terms are often used interchangeably. COA is the recognized industry umbrella term that encompasses four types of COAs, PROs being one of them. ePRO refers to information provided directly from the patient about symptoms, side effects, drug timing, etc. captured on an electronic device.

eCOA can be deployed through various technologies including smart phones, tablets, computers, integrated devices, etc. This electronic collection enables better data quality and compliance in comparison to paper – ultimately giving patients a platform to share their experiences in a clinical trial and increasing the likelihood of regulatory approval for sponsors.

eCOA offers substantial benefits over paper. In fact, more study sponsors now exclusively work with eCOAs without any paper data collection methods. Here’s some of the key reasons to use eCOA over paper:

• Higher compliance
• Improved data quality
• Paper has hidden costs
• Better patient experience
• Enhanced operational efficiencies
• Supported by regulatory agencies

Yes. Patient protocol compliance increases when patients are more engaged. When using eCOA, compliance levels can reach well over 90% as it is easier for patients to access and submit their entries, while also providing timestamps of each entry, giving sponsors confidence in the reliability of the data. Paper data collection methods show a decrease in compliance. Paper assessments do not effectively engage patients and offer no controls over data entry timeliness or quality.

Source: Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient non-compliance with paper diaries. BMJ. 2002;324(7347):1193-1194.

Yes. eCOA enables real-time data streams and accurate timestamping and data entries, which improves monitoring of the data coming in for a given study. In addition, this data is encrypted and protected, ensuring patient data safety. eCOA can also be integrated with other data sources.

BYOD – or Bring Your Own Device – allows patients to use their own smartphone or Internet-enabled device to complete field-based assessments in a study. For sponsors, the main perceived benefit of BYOD is a reduction in cost and logistical burden compared to provisioned devices. For patients, the benefit of BYOD is the ability to use the device that they are familiar with, which also reduces the burden of having to carry multiple devices.

There are many considerations when deciding on BYOD versus provisioning devices. Our team of eCOA experts can help determine which approach will best meet your study goals.

Yes. In fact, current regulatory guidelines strongly encourage sponsors implement electronic patient data capture over traditional paper methods. The adoption of eCOA is widely accepted by regulatory bodies including the FDA and EMA. eCOA can help to ensure a clinical study follows the ALCOA principles of obtaining Attributable, Legible, Contemporaneous, Original and Accurate data. Regulators are increasingly promoting eCOA and are willing to include outcomes in product labels to promote product differentiation.

The IQVIA electronic Clinical Outcome Assessment (eCOA) solution is an advanced study build and execution platform to help optimize real-time, direct-from-patient data collection. Fast, flexible and proven, IQVIA eCOA runs on devices patients already know and use to collect direct-from-patient data that is clean and ready to use in real time across clinical workflows. As an agile solution, IQVIA eCOA accelerates trials and enhances the patient experience so you can bring new medicines to market faster.

At the center of our eCOA solution is the Sculptor tool. Built on a highly secure, scalable SaaS platform, Sculptor enables simple set up of all eCOA study activities. The dynamic building tool makes it easy to create and deploy your own eCOA solution and view a functioning version of the design on multiple devices simultaneously. Key features include:

• Simple ‘drag and drop’ functionality with widget toolbox to build forms
• Dynamic and fully customizable page canvas
• Library of pre-built assessments
• Model assessment on multiple devices in real-time
• Auto generate specification documents
• Manage notifications and define scheduled exports
• Robust reporting and integration

Scribe is the patient facing application as part of the IQVIA eCOA solution. For patients, the app features a simple and consistent, user-friendly design that encourages interaction. Key functionalities include:

• Ability to use online or offline
• Supported by iOS and Android devices
• Passive study updates eliminating need for patients to visit app store
• Supports device provisioning or bring your own device (BYOD)
• Scheduling capability for alerts and reminders to improve compliance
• Multi-factor authentication (MFA) and data encryption to protect data

Easy to use and accessible to patients via their smart devices, IQVIA eCOA enables customers to build and deploy real-time patient data collection solutions in clinical research and real-world studies. The platform provides a superior user experience for study teams and patients.

• Reduce study start up timelines – IQVIA’s eCOA platform enables set up of eCOA up to 3 times faster than traditional methods while improving quality
• Increase efficiency – eliminate manual efforts through auto-generated project documentation and an extensive library of pre-built assessments
• Improve data quality and compliance – accurate timestamping and data entries, comprehensive scheduling and reminders
• Real-time insights – view study data in real-time, for better insights and faster decision-making

The IQVIA eCOA library provides robust electronic instruments on-demand, giving sponsors instant access to validated tools that are needed in a given study. We currently have over 1,400 pre-configured assessments in the library and are continuing to build it out further.

Benefits of our library include:

• Rapid study build – enables quick start up of eCOA studies
• Reduced risk – eliminates potential for error in study start up
• Improved data quality – reusability enhances data consistency
• Increased efficiency – reduces licensing and translations process

Yes, we offer flexible engagement models to best meet your needs. IQVIA eCOA is built on a highly secure, scalable SaaS (Software as a Service) enabled platform. Our SaaS offering is licensed on a subscription basis, which includes the technology licenses only, services are provided separately. In addition, we also offer our eCOA solution through stand-alone and full-service opportunities.

IQVIA eCOA cuts up to three months from the industry standard eCOA development timeline. Our eCOA development timelines are between 4-6 weeks, compared to the industry standard of 12-16+ weeks.

By incorporating an agile development process, and with capabilities including our library of pre-built assessments, IQVIA eCOA dramatically reduces the time to develop these tools while improving data quality and enhancing the patient experience. Current industry timelines for most eCOA vendors is between 12-16 weeks. However, 16 weeks or longer is more common given the outdated technologies utilized and workflow processes that lead to issues and cause delays.

^{Source: ePRO Consortium: https://c-path.org/wp-content/uploads/2019/05/2019_session5_ecoa_final.pdf}

Yes, our solution can support BYOD and we also provide provisioning services for devices as needed. There are many considerations when deciding on BYOD versus provisioning devices. Our team of eCOA experts can help determine which approach will best meet your study goals. 

If you’d like to learn more about IQVIA eCOA or to schedule a demo, please submit your information through this contact form. You can also email us directly at ecoa@iqvia.com. We’d love to hear from you and answer any additional questions you may have.