What Is ePRO and How Is It Used In Clinical Trials?

ePRO (short for electronic patient-reported outcomes) is a term that describes a category of clinical trials software which enables patients to digitally report their trial experience via their smartphone, tablet or computer, replacing the traditional approach of using paper forms.

In clinical trials, another common term that is associated with ePRO is eCOA, which stands for “electronic clinical outcome assessments”. This term refers to all electronically recorded outcomes, inclusive of patient-reported outcomes. While eCOA is the broader category which contains ePRO, many clinicians will use this term instead to refer to electronic patient-reported outcomes.

There are numerous benefits to using ePRO in clinical trials for both patients and clinicians, and this single switch to a paperless data collection process has potential to significantly improve the overall patient study experience.

Furthermore, ePRO has several benefits to you as a study sponsor when it comes to processing and understanding your study data. Since patients input their findings directly in a digital format, depending on the features of the ePRO solution you pick, you and your team will be able to monitor, analyze and respond based on the data you are seeing.

For example, some ePRO solutions are able to provide you with real-time attribution, which allows you to identify and address challenges or opportunities significantly faster than with traditional paper form patient-reported outcomes.

What Are The Benefits of Using ePRO In Clinical Trials?

At ClaraHealth, the patient experience is at the very essence of our core values as a company, and incorporating ePRO software into your trial is one of the ways to design an inclusive, accessible and patient-centric clinical trial.

In fact, going paperless for the collection of patient-reported outcomes is a mutually beneficial route that helps everybody involved in the trial, including patients, clinicians and your own internal study team.

In a 2015 market research survey involving 166 respondents that represented three groups: study sponsors, study sites, and CROs, it was found that over 86% respondents had a preference for ePRO over paper diaries.

Benefits of ePRO in Clinical Trials for Patients, Clinicians & Sponsors:

Increased Safety for Participants

When using an ePRO solution, the collected data is digitized, which enables researchers to receive feedback from patients as close to real-time as possible.

While there are several benefits to receiving real-time patient-reported data in clinical trials, the most important one is that it allows sponsors to mitigate the risk of potentially harming patients with the investigative treatment, since feedback on overall wellbeing and symptoms can be monitored and responded to significantly faster.

Improved Overall Patient Experience

In a 2013 clinical study that was conducted by a pharmaceutical company Almac, it was found that 77.3% of patients preferred to use an electronic format to submit their responses opposed to the traditional paper form format. Patients prefer this format opposed to paper forms, as it is more convenient, and for some patients more accessible.

However, it is also important to recognize that not all patients are equipped with internet access or have smartphones, tablets or computers, which could potentially decrease accessibility to these patients. If you are going to use an ePRO solution for your clinical trial, you would have to keep in mind that there may be patients that may not be able to complete their study outcomes using ePRO, and would require paper forms instead.

Alternatively, you may choose to supply such patients with necessary equipment to use ePRO, which would require a phone or a tablet with an internet connection for the duration of their participation in the trial.

Higher Patient Protocol Compliance & Improved Data Quality

In a study published in the British Medical Journal, and reviewed in this paper by Applied Clinical Trials, it was found that there is a significant difference in protocol compliance rates for patients using paper diaries and ePRO diaries.

The paper diaries patients were using were digitally powered, giving researchers insight into how the patients actually completed their entries. Researchers were able to track diary use unobstructedly, and monitor on which days and at what time the paper diaries were used, revealing information regarding late entry submissions.

While the apparent compliance in patients using paper diaries was high (around 90%), it was found that actual compliance was averaging to be only 11%. This means that 89% of paper cards were falsified and did not meet the compliance requirements.

In contrast, patients that used an eDiary to report their outcomes had an actual compliance of 94%, confirming that using an ePRO solution in a clinical trial leads to higher quality data, and increased patient protocol compliance.

How To Get Started With ePRO For Your Clinical Trial?

To get started with setting up ePRO for your clinical trial, we recommend that you first get in touch with various vendors and request their feedback for how exactly their solution will be able to help you. In this way, you will be able to see which vendor has a solution in place that is flexible enough and the right fit for your particular clinical trial.

The degree to which implementing ePRO will be helpful in improving the overall experience for all of your stakeholders will vary based on the features, reliability, customization, and support that you are able to receive from the ePRO vendor of your choice.

It is advised to determine the deal-breaker features that you would like to have as part of the ePRO experience for patients, so you can consult the vendors and see how they are able to help you with them. For example, you may require custom graphs and survey notifications, or your trial participants may require a device to be provided to complete their e-diary entries.

It is recommended that you ask the prospective ePRO vendor to speak directly on how the features of their solution fit with the unique needs that you have when designing your trial.

17 Best ePRO Vendors in 2021

1. Castor EDC

Founded in 2011, Castor EDC has grown to become one of the largest and highest rated Electronic Data Capture systems for clinical trials.

More than 65,000 users across 90+ countries use Castor EDC for ePRO, eConsent, eCOA, and eSource solutions.

  • Fast Setup: Allows sponsors to build studies within hours using pre-built templates that integrate patient, clinical, EMR/EHD, and device data. More than 90% of studies are built and pass UAT in less than 4 weeks, which is significantly faster than the industry average.
  • Customizable & Complex ePRO surveys: Sponsors are able to use the Castor ePRO software independently (via interactive dashboard) to create customizable surveys.
  • Multilingual Support: Supports multiple languages as needed based on the study requirements.
  • Patient Engagement: Variety of features built into the software that work to engage patients, including: automated alerts, survey reminders, bulk invites for survey participants, and dynamic dashboard to track survey progress.

2. Medable

Founded in 2015, Medable is one of the fastest growing companies in the decentralized clinical trials space, and was named “Leader in Decentralized Clinical Trial Products” by Everest Group.

The company specializes in decentralized products which includes the following product capabilities: ePRO/eCOA, remote patient monitoring, medication adherence, eConsent, wearables, and televisit.

  • Decentralized Clinical Trials Platform: Medable offers their ePRO solution as a single module, or part of an integrated Decentralized Clinical Trials (DCT) platform.
  • Flexible Data Collection: Medable ePRO allows you to capture clinical data in-person (via clinicians on site) or remotely from the comfort of the patient’s home.
  • Wearable Device Integration: Allows native device integrations with smart watches, glucometers, scales, thermometers, and other smart devices.
  • 3rd Party Data Integration: Offers capabilities for 3rd party data and workflow consolidations, allowing you to build and deploy complex and integrated study forms.

3. AssisTek

AssisTek has worked with more than 75 pharma and biotech clients across 46 different therapeutic areas, and their solutions have been utilized in more than 500 clinical research studies.

  • High Customization: Any event or situation can be entered in to the eDiary, based on the study requirements.
  • eCOA Tablet: Patients can use their own devices to submit an a study diary entry, and AssisTek can provide a TEK eCOA Tablet to patients that do not have a device or access to the internet.
  • Instant Data Sharing: The study team is able to have instant access to data as soon as a patient submits their entry.
  • Multiple Language Support: Can support multiple languages based on study requirements.
  • Variety of Data Collection Solutions: Offers a variety of eCOA solutions, including: TEK eConsent, TEK eCOA Tablet, TEK eDiary, TEK Configurator and TEK Study Portal

4. ArisGlobal

With over 30 years of experience, ArisGlobal provides intelligent cloud software solutions (LifeSphere® Platform) that helps to digitize the data collection processes in clinical research.

  • Compatible With Patients' Devices: ArisGlobal’s ePRO software allows patients to use their own devices to make submissions.
  • Easy Integration: The LifeSphere eCOA platform can be integrated with other clinical systems which allows for full automation and avoids redundant data entry.
  • Real-Time Capabilities: All updates are captured and delivered in real-time, allowing sponsors and clinicians to respond as soon as possible to patient feedback and mitigate risks.

5. Signant Health

With over 20 years of experience, Signant Health (formerly known as Bracket Global) is a clinical trial data technology company and specialty services provider that focuses on helping pharma and biotech sponsors and CROs to increase the impact of their clinical data.

  • Pre-Configured eCOA Templates: Signant Health has a variety of pre-existing templates which give a strong foundation when building the ePRO solution, allowing them to accelerate the deployment of the software, while ensuring quality and cost effectiveness.
  • Alerts & Notifications: Able to limit missing data and protocol non-compliance through the use of helpful alerts and reminders to patients.
  • Flexible Device Support: Patients are able to use their own devices, access the dashboard through the web, or Signant Health can provide devices for patients to use throughout the duration of the study.

6. Crucial Data Solutions

Crucial Data Solutions (CDS) is a provider of innovative and affordable solutions for data collection in the clinical trials industry. Since being founded in 2010, CDS has grown to service over 10,000 global users across 7,000+ studies.

  • Fast Setup: Crucial Data Solutions’ main offering is their cloud-based platform that allows sponsors to design, build and deploy regulatory compliant studies via an intuitive drag-and-drop form designer.
  • Flexible Device Support: CDS supports multiple devices for their ePRO and eCOA solutions, including those running iOS and Android operating systems, as well as web platforms.
  • Wearable Device Integration: Offers the ability to collect real-time patient data via a wearable device (Apple Smartwatch) including heart-rate, step motion and range of motion.
  • Alerts & Notifications: Allows to set up completely automated notifications to remind patients to make survey submissions on time, thereby increasing protocol compliance.
  • Hand-off Mode: Patients are able to complete surveys alongside clinicians (for surveys taken locally at sites), which eliminates the need for patients to have their own devices or login access.

7. Curebase

Founded in 2017 and based in the San Francisco Bay Area, Curebase offers decentralized clinical trials software solutions to sponsors, clinicians and patients.

  • Decentralized Clinical Trials Platform: Curebase has build a decentralized clinical trials software solutions suite, which includes 5 core capabilities: ePRO/eCOA, eConsent, Telehealth, eSource, and Site/Investigator Portal.
  • Integration With Other Clinical Trial Management Systems: Offers the ability to integrate ePRO with your EDC, IRT or other systems as needed. Technical support to complete a needed integration is available from Curebase’s technical team.
  • Real-Time Data Collection: Data is made available to sponsors and clinicians as soon as patients submit their surveys, allowing sponsors to respond as soon as possible to unusual and unexpected outcomes and keep study patients safe.

8. Ennov

Ennov is a global company that develops unified software solutions for pharmaceutical and biotech companies, with offices in the US and Europe. The company has been in business for over 150 years, and for the last 20 years has been developing data collection and management software solutions for clinical trials.

  • Ennov Clinical Suite: Ennov offers a clinical trials management software ecosystem which includes Ennov ePRO, along with Ennov EDC, Ennov RTSM, Ennov CTMS, Ennov eTMF, TMF Archive, eLearning.
  • Flexible Device Support: Allows patients and clinicians to have cloud-based access to the ePRO software via smartphones, tablets and computers.
  • Alerts & Notifications: Sponsors are able to deploy custom and automated notifications to alert patients to complete their entries on time, ensuring protocol compliance.

9. Datatrak

Datatrak offers a multi-component, cloud-based clinical trial management software platform that consists of a complete portfolio of software solutions designed to accelerate the data collection and reporting processes in the management of clinical trials.

  • Datatrak eClinical Solutions: Datatrack offers a platform for clinical trial management, which includes the following features and capabilities - CTMS, EDC, Medical File Imaging, ePRO/eCOA/eConsent, Training, Trial Design, and RTSM.
  • Flexible Device Support: Patients are able to use their own devices (including smartphones, tables, and computers) to report on their study outcomes.
  • Flexible Design Tool: Sponsors are able to easily build study forms via an intuitive interface and a library for standard ePRO forms, avoiding the need for programming and accelerating setup times.
  • 3rd Party Data Integration: Offers capabilities for third party data and workflow integrations, allowing you to build and deploy integrated study forms with data drawn from patients, EDC, CMTS, and third party sources.

10. OpenClinica

Founded in 2004, OpenClinica is a healthcare technology company that specializes in clinical data collection and management, ePRO, and eCRF. OpenClinica’s platform has been utilized in over 10,000 studies worldwide by various biopharma companies, CROs, academic institutions and government agencies.

  • Flexible Device Support: Patients are able to use any device to access the OpenClinica ePRO platform and submit their diary entries.
  • Alerts & Notifications: Sponsors can set up custom notifications to be sent via SMS or email, ensuring a higher protocol compliance.

11. Medidata Solutions

Medidata Solutions is a large American-based software company that builds software solutions for various uses in clinical trials. Founded in 1999 and headquartered in New York, the company has grown to over 2800 employees and has offices in China, South Korea, Japan, Singapore, UK and the US.

  • Medidata Patient Cloud: Medidata has a unified software platform for running and managing clinical trials, which includes the following capabilities - eCOA/ePRO, eConsent, myMedidata, and Sensor Cloud.
  • Flexible Device Support: Medidata’s ePRO solution is accessible to patients via an iOS or Android app, or as a web-based solution that does not require an app to be installed.
  • Pre-Built/Pre-Approved Templates: Their platform offers a variety of pre-built templates which may be helpful in accelerating the setup process, and thereby accelerate your study or timelines.

12. WCG Clinical

Founded in 1968, WCG Clinical is the world’s largest provider of ethical and regulatory review services for clinical research. Some of the company’s offerings and services include study planning & site optimization, patient engagement, scientific & regulatory, market insights, as well as a variety of software solutions.

  • Expert Clinician Services: What differentiates WCG Clinical’s ePRO solution is that the company has a team of statisticians and clinical scientists that are available to lead you through the entire solution design process. One of the benefits of working directly with WCG Clinical to implement ePRO is that their teams are able to help you select quality data metrics and can consult you on the survey design. This allows you to have higher accuracy when collecting and interpreting the patient data.
  • Design Patient and Staff ePRO Training: Another support service that WCG Clinical offers is helping you to design a training program for your staff and patients to give them the proper understanding required on how to use your customized ePRO solution. While it is hoped that the ePRO software is intuitive enough that it can be used with minimal training, depending on your particular study patient demographic, this additional service may prove to be helpful and worthwhile to ensure convenience and comfort for the patient, as well as accuracy in reported data.

13. Clinical Ink

Clinical Ink is a global healthcare technology company that builds and implements data collection and management systems for use in clinical trials. Founded in 2007, the company has grown to over 200 employees and has been featured as a “major contender” by Everest Group in their Decentralized Clinical Trial Products PEAK Matrix report for 2021.

  • eSource Ecosystem Lunexis Platform: Clinical Ink offers a central platform for running your entire traditional or decentralized/virtual clinical trial, which includes four configurable clinical modules: Direct Data Capture, eCOA, ePRO and eConsent solutions.
  • Flexible Device Support: Clinical Ink enables patients to use any device of their preference to create diary entries (a feature known as BYOD) or can provision smartphones to both patients and sites for the duration of the study.
  • Rapid Study Builds: Clinical Ink’s internal study design teams are able to build your entire custom ePRO solution, enabling you to save time and internal resources to build a high-quality patient and clinician ePRO experience in as little time as possible.

14. Medrio

Founded in 2005, Medrio's initial team of founders and innovators embarked on building the first cloud-based EDC platform. Headquartered in San Francisco and with over 185 employees, Medrio supports sponsors, sites, CROs and patients with a variety of intuitive and flexible eClinical tools.

  • Trusted Experience: Medrio ePRO has been used in over 330 studies across a variety of therapeutic areas and research stages. In addition, Medrio’s expert team has a combined experience of over 25 years to help support you in study design, guidelines, and licensing when it comes to your unique clinical study.
  • Flexible Device Support: Medrio ePRO offers high flexibility in device support; patients are able to use their own devices to respond to survey questions in real-time and remotely, regardless of where they are located.
  • Alerts & Notifications: Custom reminders can be set up to give patients helpful support for completing their study surveys consistently and on time, which ensures higher protocol compliance, data quality and accuracy.

15. ERT

ERT is a global data collection & management healthcare technology specializing in software solutions & services for use in clinical trials. Founded in 1972, the company brings nearly 50 years of experience in clinical research across a large variety of therapeutic areas.  

  • Trusted Experience: ERT’s eCOA solution has been used in over 3,500 trials, by 209,000 total sites and over 1.3 million patients. In 2017, more than 60% of FDA treatment approvals were from studies that were supported by ERT.
  • Real-Time Capabilities: ERT offers real-time and remote data collection capabilities, which allows researchers to respond to feedback and identify challenges as soon as possible, ensuring the safety of participating patients.
  • Flexible Device Support: Patients using the ERT ePRO solution are able to bring their own devices and report their study experience observations remotely, regardless of where they are located and via smartphone, tablet or a computer.

16. YPrime

Founded in 2006 and based out of Malvern, Pennsylvania, YPrime is a global provider of clinical data services to sponsors and CROs. YPrime’s mission is to support their clients in the accurate and timely completion of clinical research that brings them to the next juncture in their drug development projects.

  • In-House 24/7 Global Helpdesk: Throughout the duration of your trial, patients and sites are provided with 24/7 support from YPrime’s in-house expert customer care team. This feature helps to ensure ePRO/eCOA operational stability and any issues that arise with your data collection processes will be addressed as soon as possible. 90% of YPrime’s support issues are resolved within the first few minutes of the call.
  • YPrime eCOA Devices: YPrime offers provisioned devices to both patients and sites which can be used on a long-term basis for the duration of the clinical trial. Main features of using YPrime’s eCOA Devices include Control & Security, Performance & Longevity, and Global Coverage.
  • eCOA Web Backup: In the case that a patient has a technical issue with completing a survey on their handheld eCOA device, the support helpdesk will send the patient an email with a link to the web backup version, which is a web-based emulator with the exact features and design of the handheld device. This allows the patient to submit survey data in compliance with the study protocol, mitigating the risk of non-completion due to device malfunction.

17. Kayentis

Headquartered in France, Kayentis also has offices in the US (Boston) and in Japan (Tokyo). Kayentis was founded in 2004, and since then has grown to over 150 employees. The company specializes in clinical research data capture, and helps to bring simplicity, quality and efficiency in the clinical data management processes for sponsors and CROs. Kayentis’ main product offering is their Clin’from eCOA solution.

  • Clin’form eCOA Devices: Kayentis offers a wide range of provisioned tablet devices loaded with their Clin’form App, which allow sponsors the flexibility to select devices that adapt to the needs of their particular project.
  • Clin’form Web Portal: The Clin’form Web Portal is Kayentis’ sponsor interface that allows for real-time monitoring and management of your clinical data.
  • Alerts & Notifications: Sponsors are able to set up custom alerts & notifications to support patients in on-time survey completion, which encourages study protocol compliance.

Choosing An ePRO Vendors For Your Clinical Trial

There is a large variety of ePRO providers on the market, which can make it difficult for sponsors to narrow their decision to a particular vendor and product that is a right fit for their clinical trial. While all ePRO solutions serve the same purpose of collecting patient data via an electronic device (such as e-diary, phone/tablet/computer, or another vendor-provisioned device), the features, specialties and core value offerings can differ substantially vendor to vendor.

Certain vendors (such as those that offer a design platform with a library of templates) will be a good choice if you are behind study timelines and would like to set-up ePRO  for your trial as soon as possible. In other cases, vendors may offer a 24/7 helpdesk, which will give you the security that any potential technical issue that arises throughout the duration of the trial will be addressed and solved as soon as possible, ensuring the satisfaction of patients and site clinicians.

To make it easier for you to understand which features you may like to see in your ePRO solution, we’ve put together a list of some of the most widely offered features by ePRO/eCOA vendors.

13 Key Features To Look For In ePRO

1. Bring Your Own Device (BYOD)

In recent years in the eCOA/ePRO space, vendors have started to offer a BYOD option, which allows patients to use their personal devices to complete diary entries via an iOS or Android smartphone, tablet, or a computer. This has helped to lower costs associated with providing patients with a provisioned ePRO device, and has become an important and must-have ePRO feature for budget-conscious sponsors.

2. Vendor Platform Ecosystem

While there are vendors that offer ePRO exclusively, there are many providers on the market that offer other data management solutions and capabilities, such as eCOA, eConsent, EDC, RTSM, CTMS, TMF, and a number of others.

Vendors will often create an entire clinical data management ecosystem that will allow you to easily integrate and use any other solution that is part of their software suite for your clinical trial. If your trial requires multiple data management solutions to be implemented, it may be more cost-effective, easier and convenient to select a vendor that will offer you all of the capabilities you are looking for.

3. Cloud-Based ePRO

Many eCOA and ePRO vendors will have a cloud-based solution, which is advantageous for synchronization of data and helps to prevent data loss. Typically these vendors will also offer options such as BYOD, and may have a combination of a dedicated smartphone/tablet app and/or a web-based application.

4. Alerts & Notifications

One of the advantages of using ePRO over paper surveys is the common feature that allows sponsors to set up automated and custom notifications to encourage patients to complete their surveys. This feature is helpful for keeping patients on track and reflects in the quality and accuracy of the data, as patients are reminded to submit their study outcomes on time and with compliance to the study protocol.

The feature to set up custom notifications has become a standard for ePRO/eCOA products, although the complexity and flexibility of the customization can vary from vendor to vendor. Some ePRO vendors offer the ability to create complex trigger-based notification flows, while others allow to set-up notifications in confinement to a particular date and time.

5. Third Party Data Integration

If you are looking to integrate data from other clinical systems into ePRO, or you would like to send ePRO survey data to another clinical system, it will be important to understand the third party data integration capabilities of the ePRO you are considering.

The presence of this feature in an ePRO solution as well as the degree of its integration capabilities may vary significantly from vendor to vendor. Some ePRO vendors may not offer this feature at all, while other vendors will have limited or wide ePRO third party integrations. Depending on the design of your trial and how you would like to manage your clinical data, this feature may or may be needed for your study.

6. Vendor-Provisioned ePRO Devices

While the majority of ePRO vendors have adapted BYOD to reduce costs to the sponsor and increase flexibility to patients, depending on your particular study and target patient population, you may require a provisioned ePRO device to be provided for your patients and/or clinicians.

Some vendors will offer BYOD exclusively - however, from our experience we have seen that it is quite common that patients do not own smartphones, and/or do not have a connection to the internet. In other cases, patients may not have a cellular internet connection when not connected to WIFI, which significantly limits their ability to submit a survey response at any time, or delays data submission to the cloud until the next time their device is connected to WIFI.

In order to increase patient accessibility, you may need a combination of BYOD and vendor-provisioned ePRO devices to be provided for patients. In this case, an ePRO vendor that offers both the ePRO BYOD option and an option to provide provisioned devices with stable internet connectivity may be your vendor of choice.

7. Data Management Portal

One of the most important parts of working with data is that after it has been collected, it should be easy and intuitive to interpret and understand. The functionality and data analysis of the ePRO sponsor-facing interface may vary greatly depending on the particular sponsor and ePRO product.

We advise that prior to picking a vendor, you ask for a detailed demo of the sponsor-facing data management and interpretation capabilities, as having a high-quality data management portal is one of the most important features for working with, understanding, and responding to patient-reported data.

8. 24/7 Support/Helpdesk

Some vendors will offer 24/7 technical support for their solution for both patients and clinicians. This is not a common feature across ePRO solutions, although it may prove to be valuable as it does happen that technical issues occur.

This feature can help with patient retention, as 24/7 support helps to alleviate frustration, keep patients on track and compliant with the protocol and improves their satisfaction. It is also often that no technical issues are present, but patients and/or clinicians may need support with using the ePRO software, and in this case a 24/7 helpdesk center will also be very helpful in ensuring that their clinical trial experience is smooth and that patients are well supported.

9. Patient and Staff ePRO Training

While generally all ePRO/eCOA vendors will provide training and support with using their solution, some vendors offer an additional service of creating training materials for your customized ePRO solution.

This feature can be helpful if you are creating complex ePRO workflows or if you are working with a patient population that would generally prefer to receive training for using a new software or may have difficulty in intuitively understanding how to use ePRO. For example, when working with a senior patient population, such training manuals on using ePRO may be helpful as this population segment did not grow up with technology and might find it difficult or frustrating to use the technology.

Although not many ePRO vendors openly advertise about having this feature to create a training guide, if you’ve found the perfect ePRO solution for your trial and would require a training manual to be created for your patient population, it is advisable to directly approach the vendor to request a custom training and see if this will be within the realm of what the vendor will be willing to offer you for your particular study.

10. Consultation With ePRO Experts

One of the add-on services that some vendors offer is the ability to consult with an ePRO expert in order to design a high-quality survey. Sponsors without strong expertise in ePRO may benefit from working with professionals that know the intricacies of designing and implementing strong ePRO survey flows. ePRO experts and consultants have the experience and expertise to create high converting and engaging forms that will allow sponsors to collect the right patient data and deeply understand it, while also supporting patients to be consistent with their submissions and meet protocol compliance.

While few ePRO vendors openly advertise ePRO design consulting as an add-on service, many vendors will be ready to consult you on building and implementing this solution for your unique clinical trial. However, particularly for those vendors that do not advertise ePRO consultation as a service, they may be ready to support you with the technical components of building ePRO, but may have limited expertise in goal-oriented form design.

If consultation with ePRO experts will be an important part of building a high-quality ePRO solution for your trial, it is important to understand the vendor’s depth of expertise in patient-centric and optimal form design.

11. Survey & Workflow Design Platform

While the majority of vendors build and program the solution custom to your trial, there is another category of ePRO vendors that supplies sponsors with a platform where they are able to design, build and implement complex ePRO workflows and surveys independently or with minimal support. Few of the vendors that offer this capability include Castor EDC or Crucial Data Solutions (CDS).

Some of the benefits of using a ePRO design platform to build an ePRO/eCOA platform for your clinical trial include:

  • Fast Setup and Implementation: Since there is no programming involved, this decreases the amount of time needed to put together an effective and working solution. In addition, vendors with a dedicated ePRO design platform typically offer a variety of standardized survey templates, which also helps to save a lot of time in the design process, allowing sponsors to significantly speed up the ePRO implementation.
  • Cost-Friendly: One of the most important factors when picking a vendor for any service is its cost. There is pressure that the trial runs within the decided budget, and this may end up limiting which vendors you can and cannot work with. ePRO vendors with dedicated design platforms do not do any custom programming, and have lower costs with delivering you the service, which allows them to pass on these savings to their customers. While it is not certain that an ePRO vendor that will provide you with a platform to design your own clinical trial will be cheaper than a full-service provider, they do typically have higher margins for providing you the service, which gives them more flexibility.

12. Multilingual Support

If you are running a global clinical trial, it is likely that you will be working with a patient population that needs to be serviced in a variety of languages. The majority of ePRO vendors offer multilingual support, as it is a necessity for working with sponsors running international trials.

While vendors may be able to support different languages, it does not mean that they will be able to help you with designing the survey in a foreign language or offer translation services. If you would like to outsource the entire design of the survey in a different language, it would be important to find out if there are any limitations to what the potential vendor is able to support.

13. Wearable Devices

In the last couple of years, the ePRO/eCOA industry has seen the appearance and use of wearables for collecting and reporting real-time patient data, such as heart-rate, step motion, range of motion, blood glucose, and weight.

  • Some smart devices for collecting real-time patient data include: smart watches, glucometers, thermometers, and scales.

While increasingly more vendors offer the ability to integrate wearable technology, the majority of ePRO/eCOA vendors do not offer these capabilities at this time. If your study design requires the use of wearable technology for tracking real-time patient data, it will be efficient to compare only vendors that offer this feature.

  • Some ePRO vendors that offer wearable technology integration include: Crucial Data Solutions (CDS) and Medable.