Top Providers of ePRO and eCOA in Clinical Trials

Electronic clinical outcome assessment (eCOA) in clinical trials

In electronic clinical outcome assessments (eCOA), clinical outcome data is collected in clinical trials using electronic devices such as smartphones, tablets, or computers[¹]. Patient-reported outcomes (PROs) refer to clinical outcomes reported directly by the patient, without interpretation by a healthcare professional or researcher[²]. Clinical outcomes can include aspects such as a patient’s health status, symptom severity, quality of life, and response to treatment, amongst many other possibilities.[³] Using eCOA in clinical trials can improve data quality and reduce errors that are more common with paper-based methods, through the real-time data input that is enabled through various technologies and setups which we will discuss further in this article before getting to our curated list of 11 reliable providers of eCOA solutions for clinical trials.

How does eCOA work?

eCOA is designed to be implemented over electronic devices such as smartphones, tablets, or computers, and is becoming increasingly popular in clinical trials because it offers several advantages over traditional paper-based assessments. Some of the main working principles involved in eCOA deployment in a clinical study include[⁴]:

• Instrument development: The instrument to be used for COA data collection/input is developed or adapted for electronic use. This involves ensuring the instrument can be used online, electronically, and/or remotely without losing validity or reliability.
• Study design: The eCOA method is integrated into the clinical trial protocol, and appropriate electronic devices and software are selected for the study.
• Patient enrollment: Patients who meet the inclusion criteria for the study are enrolled and given any necessary electronic devices for completing the eCOA assessments, such as wearable or connected devices.
• Training: Patients are trained to use the wearable/connected electronic devices and any associated software and are given instructions relevant to completing the eCOA assessments according to the trial protocol.
• Data collection: The eCOA assessments are completed at specified time points during the study, and the data is recorded and stored electronically.
• Data analysis: The eCOA data forms part of the trial data and is analyzed to assess the safety and efficacy of the intervention tested in the clinical trial.

What is the difference between eCOA and ePRO?

eCOA, meaning electronic clinical outcome assessment, and ePRO (electronic patient-reported outcomes) are both digital methods used to collect clinical outcome data in clinical trials, but they are not the same thing.

To begin, eCOA is a broad term encompassing various electronically-assisted methods of collecting data related to the patient’s condition and clinical outcomes. eCOA data can be collected using various devices such as smartphones, tablets, and computers, and enables health outcomes to be reported remotely, in real-time, or even passively. eCOA includes patient-reported outcomes (PRO), clinician-reported outcomes (ClinRO), observer-reported outcomes (ObsRO), and performance outcomes, reflecting the fact that data can be entered by various different actors, be it the patient themself, their caretaker, or their study physician or investigator. In other words, ePRO specifically refers to clinical outcomes reported directly by patients, and is a specific type of eCOA, where eCOA also encompasses other digitally enabled outcome assessments that may involve interpretation by a physician or assistance with data entry by a caregiver. ePRO may be collected using web-based questionnaires, surveys, rating scales, or other types of inquiries.

What is the purpose of ePRO?

The purpose of ePRO in clinical trials is to obtain accurate and reliable data directly from patients regarding their symptoms, quality of life, and treatment-related adverse events. This approach empowers patients to engage more actively in their participation, and real-time data entry reduces bias that can arise when patients try to recall how they felt at certain points in the past or when potentially feeling uncomfortable in clinical settings.

Traditionally, patient-reported data were collected through paper-based questionnaires, which are relatively more subject to errors due to incomplete or inaccurate responses. Electronic data collection using ePRO has several advantages over traditional methods, including[⁵]:

• Increased accuracy and completeness of data: Electronic data collection reduces errors and improves the completeness of data by requiring patients to answer all questions before submitting the form, and via built-in field validation and formatting.
• Real-time data access: The research team can instantly access electronic data, enabling timely decision-making during the trial. This may be especially important for identifying adverse events quickly.
• Improved patient engagement: ePRO in clinical trials can improve patient engagement by providing patients with a convenient and user-friendly interface for completing questionnaires.
• Cost-effectiveness: ePRO eliminates the need for paper-based data collection and manual data entry tasks, reducing administrative costs.

Now that we have covered the utility of eCOA in its various forms, including ePRO, let’s take a look at some of the most widely used and established eCOA/ePRO solutions available for clinical researchers and sponsors.

Top 11 providers of ePRO and eCOA in clinical trials

The following is a list of 11 established and trusted providers of ePRO and eCOA in clinical trials that we have curated to help you find the solution that is right for your organization/trial. Each provider offers unique features that can help investigators collect clinical outcomes in real-time, remotely (if needed), and with enhanced data integrity and control.

Medidata eCOA

Medidata eCOA is part of its unified Clinical Cloud® platform and integrates seamlessly with Medidata’s other systems such as Rave EDC and Rave eConsent, offering a comprehensive, unified suite of solutions that can be customized depending on the sponsor’s/trial’s needs. The platform provides patients multiple ways to engage with the trial platform, including through a mobile app, and has a dedicated patient support system (Patient Cloud Helpdesk). Medidata eCOA also stands out for its library of pre-built and standard assessments, making it easy for sponsors to choose the right assessments for their trial without having to develop them from scratch. Medidata has an established track record of experience in the clinical trial industry, having assisted numerous trials, sponsors, and sites. They provide dedicated patient support teams, are available in different languages, and have translated their manuals to ensure ease of use.

May be ideal for: Sponsors looking for a reputable, single-solution provider integrating numerous trial management functions.

Suvoda

Suvoda’s Clinical Trial Technology Platform is a highly user-friendly product suite integrating IRT, eCOA, and eConsent into one single sign-in platform optimized for seamless workflow. The integration of these three systems into a single software platform is designed to optimize user experience for patients, sites, and sponsors, and offers highly secure data sharing. Their technology is “low-code/no-code,” meaning that the platform can be customized to each unique trial – even very complex trials – and enables changes to be made without requiring developer involvement.

Suvoda offers a variety of options for data collection, including patient self-reporting via web and mobile applications, as well as integration with wearable and connected devices. Suvoda's ePRO solution is also fully customizable to meet the unique needs of each study. Suvoda has an established track record of experience, having assisted hundreds of trials, sponsors, and sites. They offer a dedicated patient support team, and their manuals are available in multiple languages.

May be ideal for: Sponsors and CROs looking for a highly configurable and flexible solution that can integrate seamlessly with other clinical trial technologies and support multiple modes of data collection.

Signant SmartSignals eCOA

Signant SmartSignals eCOA integrates smoothly with its own related solutions, such as eConsent and RTSM/IRT, ensuring seamless integration and reducing clinical trial burden on the study team. Additionally, Signant have a dedicated support team for patients that is available in different languages, ensuring that patients are well-supported throughout their trial experience.

Another impressive feature is its library of pre-built/standard assessments, which can save sponsors time and effort in developing new assessments. This feature boosts the flexibility and adaptability of the platform, making it easier for sponsors to customize the eCOA solution to meet their specific needs.

May be ideal for: Sponsors looking for a highly customizable, flexible, and efficient eCOA solution that can improve data quality and patient engagement in their clinical trials.

IQVIA

IQVIA eCOA is part of the IQVIA Patient Engagement Suite that leverages IQVIA's extensive experience in clinical trial technology to provide sponsors with a highly configurable and flexible eCOA solution by integrating smoothly with other IQVIA clinical trial technologies such as their IRT, EDC, and safety systems. This integration ensures a seamless end-to-end solution that simplifies trial management and streamlines data collection.

IQVIA eCOA offers various options for creating and deploying questionnaires, including tablet-based, web-based, and mobile-based applications. Its highly adaptable nature allows sponsors to make changes on the fly, ensuring that the eCOA solution remains aligned with the evolving needs of the study. The system offers various support services, including training, technical support, and translation services, ensuring sponsors and patients have the support they need to navigate the platform.

May be ideal for: Sponsors looking for a highly configurable eCOA solution with strong support for both sites and patients throughout the entire clinical trial journey.

Clario eCOA

Clario eCOA is a highly configurable eCOA platform that allows sponsors to tailor the solution to meet the specific needs of their study, and its user-friendly design makes it easy for patients to navigate and complete questionnaires. The system also offers a wide range of assessment types, including patient reported outcomes (PRO), clinician reported outcomes (ClinRO), and observer reported outcomes (ObsRO), making it ideal for a diverse range of study designs and clinical endpoints. Clario eCOA integrates smoothly with other systems such as eConsent, and Clario offers their own connected devices and a library of pre-built/standard assessments.

May be ideal for: Sponsors looking for a highly configurable, user-friendly solution that offers a broad range of pre-built assessments.

Castor ePRO

Castor ePRO is designed to be easy to use and customizable, allowing sponsors to capture data in any way that suits the unique needs of their study. Castor ePRO integrates with Castor’s EDC (Electronic Data Capture) platform, enabling simple unification of patient data, reducing errors and improving the accuracy and completeness of data. Moreover, Castor ePRO supports various media types, including audio, image, and video, enabling sponsors to collect rich multimedia data. It also offers a range of features designed to enhance patient engagement, such as interactive questionnaires and automatic reminders and alerts.

May be ideal for: Trials that require frequent data collection, such as those involving chronic diseases or long-term treatments, wherein maintaining high patient engagement is a top priority.

YPrime

YPrime eCOA offers a range of innovative features that make it highly customizable to meet the specific needs of each study and integrates smoothly with other systems such as EDC, IRT, and clinical trial management systems (CTMS), ensuring that data is captured and shared accurately and efficiently, further reducing the workload placed on sites and the study team. The platform has a library of pre-built/standard assessments which allow for rapid setup and compliance with various standards. YPrime eCOA supports multiple languages, ensuring patients around the world can interact with the platform in their preferred language. Furthermore, the platform provides patients with a range of options for completing study questionnaires, including web-based and mobile applications, providing even greater flexibility and convenience.

May be ideal for: Sponsors looking for a flexible eCOA platform that includes pre-built/standard assessments and offers patients a user-friendly interface and multi-language support.

WCG eCOA/ePRO

WCG eCOA/ePRO provides sponsors with an all-in-one solution that is fully customizable, scalable, and compliant with regulatory requirements. The platform integrates readily with WCG’s complete suite of clinical services, such as eConsent, IRT, and risk-based monitoring, as well as with other third-party tools and laboratory information management systems (LIMS). WCG claims to enable faster completion of study setup than any other eCOA provider, at just 4 to 6 weeks, supported by their unique form builder technology that incorporates edit checks and clinical guidance.

May be ideal for: Sponsors conducting large, complex clinical trials that require a high level of customization and scalability yet with rapid setup times.

ClinCapture eCOA/ePRO

ClinCapture offers sponsors full configurability, ensuring that the system is tailored to meet the specific needs of each study. It can be fully integrated with other systems, such as EDC, ensuring that data is collected and managed seamlessly across multiple platforms. Further, ClinCapture has its own ePRO app, making it easy for patients to provide data directly through their mobile devices, and offers a variety of assessment options, including standard assessments and custom assessments, providing sponsors with flexibility and the ability to tailor the assessments to the specific needs of their study.

May be ideal for: Sponsors looking for a highly customizable, user-friendly, and efficient eCOA/ePRO solution that is accessible and easy to use for patients.

Medable

Medable eCOA/ePRO is an innovative solution that directly combines eCOA and ePRO, enabling sponsors to collect a wide range of patient-reported data electronically. The system is designed to further integrate smoothly with other systems such as eConsent and RTSM/IRT. Medable offers a library of pre-built/standard assessments, reducing the time needed for setup and customization. Patients can enter study data using their preferred devices, including mobile phones and tablets. The system is also highly secure, ensuring patient data is always protected and facilitating regulatory compliance.

May be ideal for: Sponsors looking for a secure and customizable solution that offers pre-built assessments for easy data collection and improved patient engagement.

Medrio eCOA/ePRO

Medrio eCOA/ePRO is a comprehensive solution that is fully yet quickly customizable, and provides users with a range of innovative features that can be tailored to meet the specific needs of each study. The system supports various languages, ensuring patients from diverse backgrounds can participate in the study. Medrio eCOA/ePRO also supports various wearable devices and external data. This feature is particularly useful for studies that require continuous monitoring of patient symptoms and other health-related parameters. Medrio has experts available for support and focuses on integrating seamlessly and painlessly into existing workflows to avoid time-consuming disruptions.

May be ideal for: Sponsors looking for a flexible eCOA/ePRO system that is easy to use and integrates easily into their existing clinical trial workflow.

Questions to ask when choosing an eCOA/ePRO vendor

As clinical trials become increasingly complex, eCOA and ePRO systems have become essential tools for collecting patient data reliably, quickly, and accurately. Choosing the right eCOA/ePRO vendor can be a daunting task given the numerous great options available in the market. Asking the right questions can help you identify a vendor that meets the unique needs of your study or organization. Here are some essential questions to keep in mind when evaluating eCOA/ePRO vendors for clinical trials.

1. Can you describe your experience in the eCOA/ePRO space?

Choosing a vendor with extensive (and relevant) experience in the eCOA/ePRO space is essential. This will ensure that they thoroughly understand the regulatory requirements and industry standards for collecting and managing patient data in clinical trials.

2. How customizable is your eCOA/ePRO system?

Every clinical trial is unique, so it's crucial to choose a vendor with an eCOA/ePRO system that is highly customizable to meet the specific needs of your study. This includes the ability to create custom questionnaires, integrate with other systems, and adapt to different languages and cultures[⁶].

3. What types of devices does your eCOA/ePRO system support?

The eCOA/ePRO system should support various devices, including smartphones, tablets, and wearable devices[7]. This will ensure that patients can easily and conveniently complete their questionnaires regardless of where they are or what types of technology they may have access to.

4. How does your system ensure data quality and patient compliance?

Both data quality and patient compliance are critical to the success of a clinical trial. Choosing an eCOA platform with built-in edit checks and validation rules is important to ensure data accuracy and completeness. Ask about features that help keep patients engaged such as reminders and notifications, and try out the interface to ensure it is interactive, intuitive, and user-friendly to avoid potential frustration or loss of interest that could lead to drop-outs.

5. Does your system integrate with other clinical trial systems, such as EDC, IRT/RTSM, and eConsent?

The eCOA/ePRO system should seamlessly integrate with any other eClinical solutions you plan to use or that are already in your workflow, such as electronic data capture (EDC), interactive response technology (IRT/RTSM), and electronic informed consent (eConsent)[⁸]. This will ensure that data is transferred accurately and efficiently across all systems, removing redundancies and errors related to duplicate data entry and manual validation.

6. Does your system support multi-language studies?

Global clinical trials often require support for multiple languages. Choosing a vendor with a system that supports a wide range of languages (including consideration of cultural nuances) is essential to ensure patient engagement and accurate data.

7. What is your pricing structure?

Finally, it's important to understand the vendor's pricing structure, including any additional fees for customization, support, and training. Ensure that the vendor's pricing aligns with your study budget and requirements. Some providers may offer stripped-down or simplified packages for trials or sponsors requiring only certain core functionalities and wishing to avoid paying for unused features.

Conclusion

Choosing the right eCOA/ePRO vendor is critical to the success of your clinical trial. Ensure you partner with an eCOA and/or ePRO provider that provides the functionalities necessary for your specific trial(s), integrates with any other eClinical solutions you already use or plan to use, offers strong support for both the sponsor and patients, and has a good reputation regarding its use in prior trials.