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.
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.
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.
MONITOR 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.
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. Collecting data on a handheld and/or tablet and/or web is also expected, including bring-your-own-device (BYOD). You can do this with our eCOA environment, and more.
Discover how universal features and functions drive data consistency.
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.
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.
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-PURPOSEOur scientific team leverages their extensive experience to ensure your study design is fit-for-purpose— that it’s optimized for the protocol to collect the right endpoint data using appropriate assessments.
- MIGRATE TO ELECTRONIC ASSESSMENTSOur team has deep experience working with scientific focus groups for usability as well as the necessary regulatory agencies for approval of new assessments.
- DEVELOP AND REVIEW ALL PROTOCOLSOur eCOA scientific team reviews and consults on every protocol (eCOA and beyond), starting at the very beginning of protocol design.
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.
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.
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.
REDUCE eDIARY CARD DELIVERY TIME BY 75%
Collect fast, regulatory compliant, and cost-effective eCOA data for vaccine studies with our vaccines platform.
STREAMLINE VACCINE STUDY TIMELINES
Vaccine development typically faces more aggressive timelines than traditional clinical trials. With ERT, you can implement a standards-based eCOA solution that enables a rapid, cost-efficient and consistent means to capture high-quality eSource patient data. This provides:
- Faster eDiary card delivery times
- Lower vaccine study costs
- 24/7 visibility to study data
IMPROVE PATIENT DATA QUALITY
Research shows that electronic data capture is preferred over paper data collection by patients and regulators. So why isn’t every vaccine study collecting eSource data?
Learn how to overcome common vaccine study challenges associated with patient data capture and discover how the ERT vaccines platform resolves them.
Developing eDiary cards from scratch for every vaccine study wastes time – and money. ERT’s vaccines platform provides a reusable set of standards to facilitate electronic data capture and collect more standardized and higher-quality patient data.
Learn how ERT’s Vaccines Platform uses an efficient design to benefit sponsors, sites and patients.
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 ASSESSMENTSGlobal regulators recommend that therapies crossing the blood brain barrier include suicidal risk assessment in their clinical trials.
- POWER ECONOMICAL ASSESSMENTSOur electronic suicide risk assessment can be integrated within any eCOA study to serve as a baseline and for ongoing insight into patient suicidal ideation and behavior (SIB).
- REDUCE PATIENT AND SITE BURDENThe ability for patients to self-report suicidal ideation has been shown to increase patient candor and provide greater clarity of patient risk.
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.
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.
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 about the reliability and validity of tablet-based eC-SSRS administration.
TAKE A CLOSER LOOK
ARTICLE: Trends Driving the Use of ePRO in Oncology Trials
Read how patient-reported outcomes (PROs), long relegated to the sidelines of clinical research and new drug application evidence, are becoming more critical to regulators’ decision making in oncology.
ARTICLE: Optimizing Rare Disease Outcomes through eCOA
Learn how proven tools ─ including effective Clinical Outcome Assessment (COA) data capture strategies ─ can overcome the challenges of rare disease research and accelerate clinical development of new treatments.
Case Study: eCOA Supports Successful Antianginal Trial
Learn how Gilead Sciences proved the antianginal efficacy of Ranexa (ranolazine) using ERT Handhelds to collect electronic clinical outcome assessments (eCOA).
POSTERS: ERT PRO/eCOA RESEARCH AT ISPOR 2017
ERT’s expert team of PRO/eCOA clinical scientists will present four posters at the 2017 ISPOR annual meeting. Their research focuses on PRO/eCOA, subject training and patient engagement for compliance.
REQUEST AN eCOA DEMO TODAY
Our team of experts is here to address any of your questions. Submit your contact information and we’ll be in touch to schedule a demo or meeting.