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Building Your eCOA Solution

Learn the basics of eCOA 101 and ePRO, as our experts help you understand what it takes to create an eCOA solution.

eCOA and ePRO - The Basics

For those of you who are new to eCOA, this is the place to start. This webinar begins with defining eCOA and ePRO, then progresses to illustrate the value of collecting Patient Reported Outcomes electronically. The final segment includes an overview of the components of an eCOA system.

Learning Objectives:

  • Understanding the value of eCOA
  • Knowing the components of an eCOA system

How to Build an eDiary, What’s Involved?

This webinar provides a little more detail regarding the design and build process for an eCOA solution. We will outline the overall process, dive deeper into typical deliverables, and round out with some considerations for you to keep in mind during vendor selection.

Learning Objectives:

  • Understanding the overall process for the design and build of an eCOA solution
  • Knowing the expected deliverables throughout the process

From Paper to ePRO: Licensing, Migration & Translation

With the ubiquity of mobile devices and associated improvements in data integrity, quality, and timeliness, there is an increased drive to collect Patient Reported Outcome Measures (PROMs) electronically. This webinar covers three integral steps anyone intending to use a PROM would follow before they deploy it electronically to patients in a clinical trial. First, it touches on licensing and variations in associated owner requirements that determine how a PROM can be used. It then focuses on Signant Health’s best practices for migrating PROMs to electronic formats to ensure that the measurement properties of the instrument are maintained. It discusses when migration best practices should be used, how they apply to each part of a PROM, and how their application can vary according to owner guidance and specifications. Finally, it provides a brief overview of the gold standards for translating PROMs. Although the webinar focuses on PROMs, the guidance and recommendations described are applicable to any Clinical Outcome Assessment (COA).

Learning Objectives:

  • Licensing of instruments and associated requirements
  • Migration Best Practices: when to use them and what they are
  • Translation Gold Standards

How to Make Translations Work for Everyone

Conducting a trial on a global scale assumes a certain amount of risk and introduces significant management challenges, many of which can be attributed to communication. This webinar sheds some light on how proper translation processes can help mitigate these risks.

Learning Objectives:

  • Understanding the challenges of translations for global clinical trials
  • Best practices for clinical trials translations

To BYOD or Not to BYOD?

Bring-your-own-device (using participant’s own smartphones/tablets) to collect ePRO data is attractive as it may be more convenient for the patient and therefore lead to greater completion compliance, and may save on study hardware and logistics requirements. In this session we explore common perceived barriers to the use of BYOD to help study teams with ePRO mode decision-making.

Learning Objectives:

  • Summarize the evidence supporting instrument measurement equivalence when patient-reported outcome measures are migrated to BYOD, and the kinds of instruments this evidence supports.
  • Explore common practical and technical considerations relating to minimizing measurement errors, missing data and optimizing data integrity when using BYOD.
  • Describe the factors that may influence BYOD decisions, and decisions between web- and app-based BYOD implementation.

Complex Diaries

This webinar focuses on simplifying the design of primarily electronic PROMs.  It covers the reasons why complex designs are problematic, then covers examples of different types of common complexities.  These include within assessment complexities, complex scheduling of assessments and study level complexities.  The Final Message?  Keep It Simple!

Ensuring Successful eCOA Operations

Understand what it takes to make an eCOA program run efficiently, logistically, and in full-compliance, in our second set of lessons.

Get Going Faster: Accelerate Timelines Without Sacrificing Quality

Reducing the time required to start collecting data via eCOA is increasingly important to trial Sponsors across the Life Sciences industry. Naturally, speed cannot be gained at the expense of quality. In this session, you will learn how Signant Health is creating a new capability to reduce startup lead time for eCOA-enabled studies without compromising quality, as well as the study Sponsor’s role in these processes.

Learning Objectives:

  • The key startup phase milestones in every eCOA-enabled study
  • Why speed matters
  • Speed via Continuous improvement – creating a new capability
  • Maintaining quality throughout the process
  • Your role in the process

Site and Participant Perspective

Dr. Elan Cohen, Principal Investigator at Hassman Research Institute, will present on eCOA from the site perspective. Dr. Cohen has great insights into eCOA features that improve data quality and at the same time offer greater ease of use for both investigators and patients. Dr. Cohen will also describe eCOA issues that can cause not just frustration on the part of investigators and patients but could also lead to diminished data quality and decreased patient retention. 

Mixing Modes of Data Capture

The ISPOR PRO Mixed Modes Good Research Practices Task Force stated, in their 2014 publication, that mixing modes within a subject is strongly discouraged except in extreme cases in which data would otherwise be missing. Mixing PRO-collection modes may occur in clinical trials when a backup solution is used, and was observed at greater scale as a response to social distancing restrictions during the COVID-19 pandemic where alternate modes were employed to enable PROM completion during periods when site-visits were not possible. However, a growing body of evidence assessing the measurement comparability of different modes of presentation of PROMs based on within-subject evaluation continues to accumulate. This session explores this evidence and its implications as we consider mixing modes pf PRO collection in pharmaceutical clinical trials.

Learning Objectives:

  • Understand current recommendations and best practices on mixing modes.
  • Summarize the evidence supporting instrument measurement equivalence when patient-reported outcome measures are migrated to BYOD, and the kinds of instruments this evidence supports.
  • List important considerations when mixing modes.

Regulatory Considerations of eCOA

There is a drive for patient-focused drug development and ensuring outcomes that are important to the patient are represented. This can be achieved through the implementation of Patient Reported Outcome Measures (PROMs) in clinical trials. This webinar will present the regulatory considerations and steps involved in selecting the right PROM or developing a new one, followed by validation considerations when changing an instrument from paper to electronic (ePRO). The focus is on PROMs but the guidance is applicable to other clinical outcome assessments (COA), including Clinical Reported, Observer Reported, and Performance Outcomes.

Our industry operates within a highly regulated environment and so if you intend to use data from these types of measures to support a medical product labelling claim, it is important to understand the evidence required by regulatory authorities during the approval process.

Learning Objectives:

  • Understand the importance of the ‘Patient Voice’ in medical product development.
  • Understand when it is appropriate to use or modify an existing measure, or develop a new one for use in a drug development program.
  • Understand the steps required to develop a new PRO instrument and modify an existing measure.
    Understand the evidence needed to support equivalence of electronic versions of instruments initially developed and validated on paper.

ClinRO Data Reliability: Why, What and How

Reliability of clinician reported outcomes (ClinROs) and raters are important objectives shared across stakeholders.   ClinROs also vary widely in their administration and scoring conventions.    ClinROs typically require specialized training and experience, as raters are required to interpret information from direct interviews and observations in scoring ClinROs.    Training of raters and ongoing quality control monitoring of ClinROs support reliable scoring and administration of scales.   eCOA and other technologies can include features and capabilities that further contribute to the reliability of raters and ClinROs.

Learning Objectives:

  • Provide a basic overview of ‘rater reliability’, and how it is measured in clinical trials.
  • Demonstrate how rater training and ongoing monitoring can improve the reliability of ClinRO data in trials.
  • Explore the impact that demonstrated and increased reliability can have on clinical trial design.



Enhancing the Value of eCOA

Take the value of eCOA beyond, and understand the benefits that combine from combining eCOA with other trial solutions.

Sensors and Wearables

The use of reliable, high performance microsensors in the medical field is of growing importance for patient health monitoring, personal wellness and clinical research. Combined with ePRO solutions, wearables and sensors can be a convenient way to collect objective clinical endpoints in real-world settings. In this session we explore and address knowledge and process gaps that may limit the adoption of wearables and sensors at scale as measurement tools in clinical drug development.

Learning Objectives

  • Describe a framework to ensure that endpoints derived from sensors and wearables data are meaningful to patients and follow patient-focussed drug development principles.
  • List the evidence recommended to support device selection and defend endpoints derived from sensor and wearable data to support new drug applications and regulatory decision making.
  • Explore current understanding whether endpoints are specific to the wearable/sensor device selected, or whether endpoints can be derived that are device agnostic.

Beyond eCOA: Adding eConsent to Your Trials

There is a clear industry shift from traditional paper consent to electronic informed consent. In this session we explore the basics of eConsent, why and how it works, key market trends and some frequently asked questions.

Learning Objectives:

  • Explore the ways in which eConsent can benefit all trial stakeholders
  • Summarize eConsent’s features and workflow components
  • Identify the biggest market trends and customer needs for eConsent
  • Share findings on adoption of eConsent

Using Blinded Data Analytics to Achieve Endpoint Quality

Quality endpoint data begins with good data collection practices. That is the role of intelligent eCOA. But even with the right data collection tool in place, how can you be confident you are collecting good data. In this session, learn how blinded data analytics can be used to increase the quality of endpoint data and improve endpoint confidence.

Learning Objectives:

  • Recognize common anomalous data patterns
  • Describe application of blinded data analytics to endpoint data
  • Summarize the impact of combining clinical insights with data analytics on endpoint quality

Keeping Patients Engaged from Enrollment through Closeout

Keeping patients involved, committed, and satisfied with their trial experience is not universal or constant. Unique patients require unique support at various points in the trial. 

This session offers a unique perspective on how to keep patients engaged by understanding: 

  • who your patients are, 
  • what they need, 
  • what they do, and 
  • what they want 

Benefits of Combining Signant IRT and TrialMax

The IRT/TrialMax session will focus on the benefits of combining these Signant technologies.  The session will focus primarily on current use cases and integration touch points.

Learning Objectives:

  • Understand current and future integration touchpoints between the solutions.
  • Understand benefits and value of bringing the solutions together.