ERT eCOA

Accelerate your research with electronic clinical outcome assessment (eCOA) technology that doesn’t get in the way.

NOT ALL TECHNOLOGY IS CREATED EQUAL

We built more than 40 years of scientific and technical experience into our eCOA environment. Streamlined workflows and regulatory adherence make ERT eCOA easy to use with less burden for both sites and patients.

2100+
eCOA Trials
50+
eCOA drug approvals
120K
eCOA sites
838K
eCOA patients

ACCELERATE YOUR RESEARCH WITH ERT eCOA

Our integrated multi-modality capabilities, unrivaled eCOA scientific expertise and electronic suicide risk assessments accelerate clinical interviews and streamline clinical workflow across your studies.

MANAGE STUDY CHANGE EFFICIENTLY

Universal screen features and functions facilitate consistent and predictable data collection on a smartphone, tablet or browser. This capability provides more efficient study change management and mitigates the need for data reconciliation.

CONSISTENT DATA COLLECTION AND INTEGRATION

ACHIEVE MAXIMUM QUALITY

Technology-based COA often requires multiple modalities to engage diverse patient populations. Compiling and reviewing data from multiple sources can delay database lock and submissions. With ERT eCOA, you can ensure maximum efficiency and data quality.

DRIVE EFFICIENCIES AND DATA QUALITY

MONITOR STUDY PERFORMANCE IN NEAR REAL TIME

Audit study performance online 24/7 using near real-time operational and clinical data. Heat mapping is available for patient/site enrollment, compliance & trending, visit schedules and device inventories.

MONITOR PERFORMANCE FOR PROACTIVE MITIGATION

COLLECT PATIENT DATA ANYTIME, ANYWHERE ON A SMARTPHONE, TABLET OR BROWSER

Improve data quality, reduce study closing times and increase patient engagement with our consistent, standardized eCOA interface.

INCREASE DATA CONSISTENCY

Integration with any medical device or wearable is expected. Avoid bias due to different screen views on multiple devices. With our eCOA environment you can collect data on handhelds, tablets and browsers as well as bring-your-own device (BYOD). Each modality uses the same consistent interface. Leverage our standardized eCOA interface in any language, for consistent data.

Discover how a universal patient interface drives data consistency.

CONSISTENT DEVICE INTEGRATION

INCREASE PATIENT COMPLIANCE

Our intuitive eCOA environment allows for simplified and predictable data collection from all patient populations. Sites have streamlined workflows and access to enrollment status on their study device, while patients have the eCOA modality they want to use. You can relate to every patient, at every site with screen text, buttons and controls in their local language. Data are automatically formatted for regulatory needs.

Understand how patient engagement and preferences for electronic devices increases compliance.

RELATE TO EVERY PATIENT AT EVERY SITE

DRIVE HIGHER DATA QUALITY

Electronically collect consistent data. The eCOA environment designs studies with flexible, intelligent components resulting in faster builds and associated IRB submissions and simultaneous mid-study updates for all modalities. Collected operational and clinical data are available online 24/7 for site and sponsor monitoring.

Check out how our wireless eCOA tablet drives higher quality ECG data.

Enable more standardized outcomes with consistent, quality data

SCIENTIFIC EXPERTISE PAIRED WITH EVERY PROTOCOL

Our eCOA clinical scientists review every protocol, assessment and study design for suitable content and patient compliance to optimize study power.

ENSURE STUDY DESIGN IS FIT-FOR-PURPOSE

Our 25-member team of clinical psychologists, neurologists, psychometricians and COA scientists design assessments and programs with electronic implementation in mind, using a dual layer of PRO and eCOA best practices. Customized rater training for clinicians, caregivers, patients and site staff safeguards the standardized use of each instrument. The team also ensures the trustworthiness of your electronic records through data protection and fraud avoidance.

Get insights on fundamental training aspects for completing assessments.

THE INDUSTRY’S LARGEST, MOST EXPERIENCED RESIDENT PRO/eCOA SCIENCE TEAM

MIGRATE TO ELECTRONIC ASSESSMENTS

Our science team has the experience working with scientific focus groups for usability and the necessary regulatory agencies for approval of new assessments. Team members can conduct cognitive debriefing and testing to ensure the electronic method is collecting the same data and in the same spirit as the paper-based method. Or, they can assist you to create a new standardized assessment, when one isn’t already available.

Get the facts about whether paper back-up is scientifically recommended.

DEEP EXPERIENCE WITH SCIENTIFIC FOCUS GROUPS

DEVELOP AND REVIEW ALL PROTOCOLS

Our eCOA scientific team reviews and consults on every protocol (eCOA and beyond), starting at the very beginning of protocol design. Early knowledge of the protocol enables the team to determine what has to be proven and achieved for patient and site compliance. Then, the PRO and eCOA trial design strategies, endpoint selection and instrument selection for optimal study power are determined based on the protocol. The team is also involved when protocol amendments are required.

Learn more about reducing placebo response and effects in PROs.

Increase protocol compliance

BUILD CONFIDENCE IN SUICIDE RISK SCREENINGS

Integrate our electronic suicide risk assessments within any study to screen for suicidal ideation and behavior.

ENSURE PROPER SUICIDE IDEATION ASSESSMENTS

Although psychiatric studies are well positioned for trained clinicians to assess suicidal ideation, non-psychiatric studies may involve clinicians who are not familiar or comfortable in assessing suicidal ideation. Both ERT electronic Suicide Risk Assessment versions — clinician-reported and patient-reported — ensure proper screening.

Get all the details on our integrated suicide risk assessments.

PROPERLY ASSESS SUICIDE RISK

POWER ECONOMICAL ASSESSMENTS

Our electronic suicide risk assessments can be integrated within any eCOA study to serve as a baseline and for ongoing insight into patient suicidal ideation and behavior (SIB). Our solution electronically integrates the Columbia-Suicide Severity Rating Scale (C-SSRS), which is the SIB assessment gold standard. The electronic C-SSRS uses a complex, systematic structure of questions that logically branch to the appropriate follow-up questions based on patient responses. The scale directly maps to and populates 11 categories of suicidal ideation and behavior, mitigating potential clinician errors in coding.

Find out more about electronic patient-reported suicidal ideation in eCOA.

REAL TIME SIB ALERTS

REDUCE PATIENT AND SITE BURDEN

The ability for patients to self-report suicidal ideation has been shown to increase patient candor and provide greater clarity of patient risk. Our proprietary, electronic C-SSRS (eC-SSRS) assessment provides systematic, comprehensive and consistent assessments by patient self-report across all sites and languages. It reduces patient and site staff burden and the time to collect the data. Because screening is accelerated, alerts for suicide ideation are more timely.

Learn more about eC-SSRS services we provide.

INCREASE EFFICIENCY WITH PATIENT-REPORTED SIB

TAKE A CLOSER LOOK

BROCHURE: ERT eCOA

Learn more about ERT eCOA, including services provided by our team of experts.

ADDITIONAL INSIGHTS

CASE STUDY: ERT eCOA MOBILE DEVICE ACHIEVES NDA FOR TERISA

Learn how Gilead Sciences proved the antianginal efficacy of ranolazine (Ranexa) using ERT mobile devices to collect electronic clinical outcome assessments (eCOA).