Patient data driven by science
We believe in leading with eCOA science to make clinical trials easier, faster, more engaging and accessible to all. Our world-class scientific expertise drives solutions which are built around your patient, powered by innovative technology and supported by over 25 years of experience.
Simplify trials for patients
Reduction in questions
Inclusivity through decentralized trial solutions
Clario eCOA helps sponsors open up trials to more communities around the world, making research more diverse and inclusive:
- Remote solutions for over 25 years, reducing patient burden and travel time
- Multilingual helpdesk across all time zones
- Assessments in over 114 languages
- Take part from any location with our flexible technology options: Bring-your-own-device (BYOD), web or provisioned device (available in over 100 countries)
Telehealth video calls and site assessments at home.
Reduce the need for patients to travel to site for trials which require image capture.
eCOA Rescue Studies
Your trusted partner to ensure you get your clinical trial back on track.
Remotely monitor for Suicidal Ideation and Behavior using Clario’s exclusive self-reported eC-SSRS + telehealth video visit service.
Clario’s eConsent solution simplifies the consent process for both patients and sites.
When capturing patient data sponsors have the choice of using paper or electronic methods. In this section we take a look at how these compare. If you’d like to discuss these options further, contact our eCOA Science team.
What is eCOA?
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.
Myth: eCOA is too expensive
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
eCOA or paper data collection?
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!
1Stone et al, Patient Non-Compliance with Paper Diaries, British Medical Journal, 2002
7 Reasons to use eCOA
- Generate high-quality data
- Provide real-time insights into patient safety
- Provide real-time insights into study performance
- Faster database lock
- Reduce study development costs
- Increase patient engagement and compliance
- Easily integrate with different data sources
Using eCOA for the first time
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.
Flexible device modalities
Clario captures the eCOA data you need for your development program studies, regulatory approval and drug differentiation. We enable patients to participate wherever they are in the world and in a way that fits into their daily lives through a choice of flexible technologies.
End-to-end support and guidance
End-to-end solutions make trials simple for you, your sites and your patients.
eCOA scientific guidance
At-home and at-site solutions
Patient oversight and safety
Local and global studies
in-house support desk
Connected devices make taking part in clinical studies straightforward. Clario’s devices are pre-validated for use in clinical trials and integrated with the eCOA device to capture ECG, spirometry, blood glucose levels, activity levels, movement endpoints and many more.
Monitor clinical trial progress in real-time
With more data being captured away from site, the ability to review real-time data across multiple solutions including EDC, eCOA and connected devices is critical.
Keep trials on track with patient, study and program data insights
Scientific guidance and therapeutic area solutions
Engage with our eCOA scientific and therapeutic area experts early on in your clinical development program to ensure the right eCOA endpoints are being measured, using the most appropriate assessments and the right technology. Our team has developed tailored solutions across multiple therapeutic areas and indications built upon 25 years of industry experience.
Talk to a specialist
Our team of experts is available to address questions you may have about our integrated eCOA solutions. Submit your contact information and we’ll be in touch shortly.