eCOA Digital Solutions

Electronic Clinical Outcome Assessments, or eCOA, measure how patients feel or function during clinical trials. This is done using a handheld, tablet, home computer or connected devices.

• ePRO: Patient Reported Outcomes. Patients report on their health via questionnaires or assessments.

• eClinRO: Clinician Reported Outcomes. Health outcomes are reported by a clinician.

• eObsRO: Observer Reported Outcomes. Completed by someone other than the patient or the clinician, such as a caregiver, based on events and behaviors observed.

• ePerfO: Performance Outcomes are measures from specific tasks the patient is asked to perform.

Learn more! Take our eCOA Basics course (45 mins self-paced) and read our blog!

Not true! The cost of poor-quality data from paper COA collection and transposition can far outweigh the cost of eCOA. eCOA also overcomes the hidden costs of paper COA – errors inherent in manual data entry can force the sponsor’s study team to spend countless hours reconciling data before manually entering them into a database. When accurately accounted for, labor costs for paper-based COA can easily eclipse anticipated eCOA costs.

McKenzie et. al realized significant potential cost savings when examining the results of a Phase III overactive bladder study using eCOA compared to a similar study using paper COA. The reduction in error variance resulting from the use of eCOA produced more sensitive study results, which could have reduced the study sample size by nearly 50%, representing a significant impact on drug development timelines and costs. ¹

¹ “Proving the eDiary Dividend,” McKenzie, S., Applied Clinical Trials, 2004

Boost your compliance and retention levels by making participation simple and engaging:

1. Capture patient data electronically

2. Keep patients informed:

• Information on their disease and the study
• Notifications for taking medication and submitting diary entries

3. Offer patients the choice of how and where to take part: how can your study fit into their lives and technology expectations?

4. Provide patient motivation! 

Download this eCOA Electronic vs. Paper infographic to find out more

¹Stone et al, Patient Non-Compliance with Paper Diaries, British Medical Journal, 2002

1. Generate high-quality data
2. Provide real-time insights into patient safety
3. Provide real-time insights into study performance
4. Faster database lock
5. Reduce study development costs
6. Increase patient engagement and compliance
7. Easily integrate with different data sources

Download the eBook to learn more

The best way to measure symptoms and functional status in clinical research is through insights provided by the patient. However, how do you go about integrating ePRO into a clinical trial? Download this white paper to learn about a completed a Phase 2 clinical trial that used electronic patient-reported outcomes for the first time and identified the key decision points, responsibilities and lessons learned.