ECOA RESOURCES AND FAQ

Learn more about IQVIA eCOA in one place.

Explore thought leadership content, common questions, and webinars on demand about IQVIA eCOA as well as industry trends such as patient-centered studies.

eCOA Licensing Guide

Five steps to licensing the assessments you need for your next clinical trial

Key eCOA Benefits to Speed up Your Clinical Trial

eCOA technologies are a cornerstone for elevating patient data collection in clinical trials. Learn how IQVIA eCOA helps address critical pain points across studies by focusing on timelines, processes and patient compliance.

The Keys to eCOA Implementation Success

IQVIA eCOA experts Anthony Mikulaschek and Piero Bindi use client case studies to explore how IQVIA eCOA reduced sponsor timelines through a holistic approach, enabled rapid study-build, and increased patient compliance.

Custom eCOA Library Accelerates Oncology Program Timelines

IQVIA eCOA worked with a large oncology sponsor to create a custom eCOA library for a new program. This tailored solution gave a global oncology program the head start it needed.

Fast. Flexible. Proven. IQVIA eCOA

Learn about the benefits of combining best-in-class technology with industry leading experience in IQVIA’s fast, flexible and proven eCOA solution.

FAQ

You’ve got questions. We’ve got answers.

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. 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 smart devices trial participants are already familiar with to collect patient data that is clean and ready to use in clinical research and real-world studies. As an agile solution, IQVIA eCOA and provides a superior experience for study teams and patients and accelerates trials so you can bring new medicines to market faster.

  • Reduce study start up timelines – set up IQVIA 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 500 validated and approved assessments and more than 2,200 pre-built eCOA forms in the library and are continuing to add more.

Benefits of our library include:

  • Rapid study build – accelerates startup 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
  • Higher confidence – deliver consistent and reliable patient data

Learn more by visiting the eCOA Library web page.

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, the IQVIA solution supports bring your own device (BYOD) and provides provisioning services for devices as needed. BYOD approaches can speed trial start-up and eliminate the cost of provisioning and updating devices.

Some sponsors are unfamiliar with how to implement BYOD and secure regulatory support since this is a newer practice in clinical research. Working with a vendor who has experience validating eCOAs for BYOD trials can ensure the pharma company conducts proper due diligence before meeting with regulators. Our team of eCOA experts can help determine whether the BYOD or provisioned device approach will best meet your study goals.

Learn more by reading this white paper or this blog.

  1. Determine whether the platform meets all regulatory requirements for data privacy and security.
  2. Choose an eCOA platform that integrates seamlessly with your existing clinical trial systems.
  3. Survey site staff who have used eCOAs in the past on what to look for and must-have capabilities when vetting vendors.
  4. Build in time for validation user acceptance testing (UAT) since any assessment used in an eCOA has to be proven to perform as expected on all potential operating systems and show that the intent of the assessment is met through every interaction.
  5. Ensure sponsors maintain complete control over the data to extract it whenever necessary for analysis and preparation for regulators quickly, securely, and with little effort.
  6. Meet your point of contact, since a dedicated project manager is the most important person on the eCOA team. Your vendor should assign an individual who will be available to solve problems, answer questions and make sure the technology works as expected.
  7. Assess participant training materials to ensure they are accessible, require few updates, and give end users everything they need to confidently use the technology.

Learn more by reading this white paper.

Site staff will be expected to constantly review assessment results, verify completion rates, and transfer data to study databases. Since this represents time spent away from patients, the best eCOA platforms are simple and easy to access with few barriers. Decision makers should focus on the speed and simplicity of workflows, with questions like:

  • How much time does it take to create a new patient profile?
  • How easy is it to monitor the status of individuals or groups of patients in the study?
  • Can investigators see compliance rates at a glance, or do they need to dig to find that information?

Learn more by reading this white paper.

Giving patients the option to download study apps to their phones rather than providing them with an extra piece of study specific hardware is convenient and familiar for users who don’t want to learn a new interface. Patients are also more likely to always have their personal devices with them, making it easy to complete assessments on time. It is another way sponsors can improve compliance and reduce the burden of participation.

Sponsors benefit from lower costs and faster timelines when they don’t have to acquire, ship and manage provisioned devices. This can accelerate study startup while potentially trimming hundreds of thousands of dollars from an overall trial budget.

Learn more by reading this blog.

IQVIA offers a novel in-house translation process that eliminates the back-and-forth communication with third-party translation agencies. Since IQVIA Translation Services and IQVIA eCOA are part of the same group, the translation service can access the IQVIA eCOA platform via internal systems for a streamlined translations implementation and review process. This cutting-edge collaboration allows translators to conduct the entire translation process digitally.

Learn more by reading this blog.

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.
Opportunities in Moving Care Nearer the Patient

A near-to-patient care system involves moving healthcare closer to the patient, bringing a range of benefits to stakeholders.

Ensuring your BYOD strategy meets the rigor of regulators

Many sponsors are still unfamiliar with how to implement BYOD and secure regulatory support.

eCOA IRT eConsent

Simplifying user experience and driving process efficiencies through integration and automation.

eCOA Technology Guide

Seven recommendations to consider when vetting eCOA technology solutions

Thought Leadership

Explore perspectives from IQVIA scientists, data management experts, and other experts

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