NOT ALL TECHNOLOGY IS CREATED EQUAL
We built more than 50 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.
HAVE CONFIDENCE IN YOUR TRIAL DATA
By implementing ERT’s eCOA solution in your next clinical trial, you will benefit from higher-quality, consistent data that you can have confidence in.
- ACHIEVE MAXIMUM QUALITYUnlike a paper-based approach, eCOA meets global regulatory quality guidelines.
- INCREASE DATA CONSISTENCYManage study change more efficiently by increasing your study data consistency.
- INTEGRATE WITH OTHER DEVICESSave time and study costs, while improving data quality, by integrating with other medical devices, wearables, EDC systems, IVR and other data streams.
ACHIEVE MAXIMUM QUALITY
Data quality can be compromised by error-prone, manual, paper-based systems. eCOA, however, ensures that all data meets global regulatory quality standards, prevents inconsistent or conflicting data, eliminates transcription errors and avoids study bias with predictable data collection.
Download ‘7 Reasons to Implement Electronic Data Collection’ to learn how ERT’s eCOA helps improve data quality.
INCREASE DATA CONSISTENCY
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 by offering a more comprehensive view of patient data and mitigating the need for data reconciliation.
Download this best practices guide to learn how ERT’s clinician rater training has been shown to improve data consistency.
INTEGRATE WITH OTHER DEVICES
With eCOA, you can save time and study costs by avoiding the manual collection of patient data from different sources. eCOA easily integrates with other medical devices, wearables and EDC systems, transmitting data wirelessly and securely to the study database.
Download this case study to learn how Gilead streamlined data management and reduced discrepancies across integrated systems.
REAL-TIME STUDY INSIGHTS & COST SAVINGS
Monitor patient safety and site performance 24/7, while benefiting from operational efficiencies.
- MONITOR SAFETY & PERFORMANCE IN REAL-TIMEStay in touch with how your study is performing.
- REDUCE STUDY COSTSWhen all the hidden costs of paper are revealed, eCOA often emerges as the much more cost-effective solution.
- INCREASE ENGAGEMENT & COMPLIANCEIncrease compliance and decrease study drop-out rates with more engaged patients.
MONITOR SAFETY & PERFORMANCE IN REAL-TIME
ERT’s eCOA delivers real-time insights into patient safety, enabling early detection of any potential safety concerns. Study performance can also be monitored 24/7 at the click of a button.
Read this best practices guide to learn how you can monitor patient safety and study performance in real-time.
REDUCE STUDY COSTS
With eCOA, you can avoid all the hidden costs of paper – including manual data entry, transcription, data cleaning, reconciliation and archiving. Given the data volumes represented by patient diaries, electronic validation alone can save 30 to 50% of trial costs.
Download this case study to learn how ERT helped Celgene save $13M in overall trial costs using eCOA.
INCREASE ENGAGEMENT & COMPLIANCE
Diary compliance can reach well over 90% with eCOA, compared to just 11% with paper. eCOA’s email alerts, electronic reminders, motivational messaging and educational content contribute to better patient engagement and protocol compliance.
SCIENTIFIC EXPERTISE PAIRED WITH EVERY PROTOCOL
Our eCOA clinical scientists optimize study power by reviewing every protocol, assessment and study design for suitable content and patient compliance.
- 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.
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.
Read this best practices guide to learn what to consider when selecting eCOA.
DEVELOP AND REVIEW ALL PROTOCOLS
Early knowledge of the protocol enables our scientific 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.
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?
Download this eBook to learn how the ERT Vaccines Platform helps you overcome common study challenges associated with patient data capture
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 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
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
Introducing BYOD 2.0: A More Inclusive Approach to Electronic Clinical Outcome Assessment
Here we present how the next wave of ePRO BYOD leverages new technologies to expand the inclusiveness of research by supporting data collection from verbal computer interfaces and wearable/external devices.
ARTICLE: ELECTRONIC PLATFORMS DRIVE IMPROVEMENTS IN VACCINE STUDY EFFICIENCY AND DATA QUALITY
Read this article to learn how the latest electronic data capture solutions are helping to deliver safe and effective vaccines faster and more cost-effectively.
INFOGRAPHIC: 4 WAYS TO IMPROVE PATIENT DATA CAPTURE IN VACCINES STUDIES
Find out how a vaccines platform helps meet FPI, shortens time to database lock, reduces site burden and ensures high-quality data.
CASE STUDY: ePRO PRODUCES HIGHER-QUALITY DATA THAN PAPER
Learn how Merck demonstrated a 41% reduction in standard deviation from the norm using ePRO.
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.