eCOA Newsletters and Webinars
Webinars
This eCOA Exchange presents the perspective of COA Measure Owners on the acquisition of licenses to use COA measures electronically in clinical trials and highlights C-Path’s plans to help reduce the friction of eCOA licensing across all stakeholders.
To access the eCOA Educational Series, please provide your email address
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Moderator: Scottie Kern (C-Path)
Presenters: David Churchman (InSpired Health Outcomes), Sonia Bothorel (MAPI Research Trust), David Bard (IQVIA), Karl McEvoy (YPrime)
eCOA libraries can be valuable assets in clinical research, offering ready-to-use, validated and pre-translated COA measures for collecting the trial participant’s voice. However, uptake varies hugely, and for a range of reasons. Do they really streamline the process and reduce costs? Join our expert panel as they identify and discuss the pros and cons of eCOA libraries, and whether we as an industry are deriving the true dividend that eCOA libraries claim to deliver.
To access the eCOA Educational Series, please provide your email address
By providing your email address, you’re agreeing to receive communications from C-Path.
Moderator: Scottie Kern (C-Path)
Presenters: Cindy Howry (Medable), Christian Knaus (Evinova), Jonathan Norman (YPrime), and Shelly Steele (WCG Clinical)
Revisiting the lively topic of Bring Your Own Device (BYOD), this event offered attendees a further chance to pose any questions to the experts that were unaddressed at the 1st eCOA Clinic or the recent collaborative webinar delivered by the eCOA Consortium and PRO Consortium entitled “BYOD: A Guide for Successful Implementation.”
To access the eCOA Educational Series, please provide your email address
By providing your email address, you’re agreeing to receive communications from C-Path.
This webinar presents an in-depth look at the key considerations around the use of Bring Your Own Device (BYOD) approaches to electronic clinical outcome assessment data collection in clinical trials, developed and presented by members of the BYOD Project Team as part of the eCOA Consortium and PRO Consortium’s eCOA: Getting Better Together Initiative.
Moderator: Scottie Kern
Presenters: Kelly Dumais (Clario), Karl McEvoy (YPrime), Heather Romero (Takeda), Chris Barden (Kayentis)
This 1st Masterclass — the fourth installment of our eCOA Educational Series — takes a deep dive into current best practices for the electronic migration and implementation of patient-reported outcome (PRO) measures, as featured in the published article in Value in Health.
To access the eCOA Educational Series, please provide your email address
By providing your email address, you’re agreeing to receive communications from C-Path.
Moderator: Scottie Kern (C-Path)
Presenters: Florence Mowlem (ObvioHealth), Ben James (uMotif), and Melissa Newara (Medrio)
This 1st eCOA Clinic — the third installment of our eCOA Educational Series — offered attendees the chance to bring their own questions on the topic of BYOD to be addressed by experts from across the eCOA Consortium’s membership, with matters ranging from the impact of BYOD on study timelines to the regulatory perspective on BYOD.
To access the eCOA Educational Series, please provide your email address
By providing your email address, you’re agreeing to receive communications from C-Path.
Moderator: Scottie Kern (C-Path)
Presenters: Chris Barden (Kayentis), Lisa Charlton (Science 37), Kelly Dumais (Clario), Karl McEvoy (YPrime), and Flo Mowlem (ObvioHealth)
This eCOA Exchange — the second in our eCOA Educational Series — identifies and examines the key considerations around the selection and implementation of sensor-based wearable technologies in clinical trials. An expert panel with deep experience in the field and formed from our eCOA Consortium members ActiGraph, Koneksa, Parexel, and uMotif share their perspectives on how successful use of these powerful tools can be achieved.
To access the eCOA Educational Series, please provide your email address
By providing your email address, you’re agreeing to receive communications from C-Path.
Moderator: Scottie Kern (C-Path)
Presenters: Julia Kling (Koneksa), Julia Lakeland (uMotif), Ian Pallett (Parexel), Sylvain Zorman (ActiGraph)
This eCOA Exchange session examines what clinical operations teams should be prepared for, from an eCOA translations and licensing perspective, when running multi-country trials. Translations and licensing experts from eCOA Consortium members Mapi Research Trust, RWS, and TransPerfect Life Sciences share key considerations and experience-based recommendations to reduce the risk to study start-up for global eCOA trials.
To access the eCOA Educational Series, please provide your email address
By providing your email address, you’re agreeing to receive communications from C-Path.
Moderator: Scottie Kern (C-Path)
Presenters: Elsa Lindstrom (TransPerfect Life Sciences), Shawn McKown (RWS), and Foteini Sakellaropoulou (Mapi Research Trust)
This webinar provides an overview of the eCOA: Getting Better Together Initiative. This collaborative, pre-competitive initiative was launched in 2019 to identify and address the root cause of issues with eCOA implementation in clinical trials and to drive positive and lasting change in the eCOA ecosystem for the benefit of all stakeholders. This webinar discusses the achievements and future goals of the initiative, in addition to recent highlights from each consortium.
Moderator: Keith Wenzel (Parexel)
Presenters: Sonya Eremenco, MA (C-Path) and Paul O’Donohoe, MSc (Medidata Solutions)
This webinar provides an update from sponsors and eCOA providers as they discuss lessons learned from managing clinical trials that originally planned for in-person collection of ePRO data through clinical sites. Due to public health concerns, many patients are either unable or unwilling to travel to sites for scheduled visits or sites have had to close. In March 2020, ePRO Consortium and PRO Consortium member representatives collaborated on risk assessment and mitigation strategies for clinical trials in response to COVID-19. This webinar discusses lessons learned, how the initial recommendations performed, and how sponsors and eCOA providers are applying these learnings to future trials.
Moderator: Sonya Eremenco, MA (C-Path)
Presenters: Patricia (Trish) Delong, MS (Janssen Global Services, LLC); Gena Gough, MBA, PMP (Clinical Ink); Cindy Howry, MS (.assisTek); Paul O’Donohoe, MSc (Medidata Solutions); and, Megan Turner (GlaxoSmithKline)
This webinar presents an overview of Good Clinical Practice (GCP)/ethics review guidelines (ICH E6 R2), which indicate that written information provided to the patient must be submitted for ethical review. Many have broadly interpreted the GCP requirement concerning “written information” to mean that screenshots for every proposed patient-facing image must be provided for review, approval, and filing prior to study information. The presenters question whether requests from ethics review bodies for eCOA screenshots is warranted and will propose a new path forward.
Presenters: Steve Raymond, PhD (ERT); Art Gertel (MedSciCom, LLC); Olivier Chassany, MD, PhD (Paris-Diderot University and INSERM); and, David Forster, JD, MA, CIP (WIRB-Copernicus Group)
Note: Audio is not available for this webinar.
This webinar provides an overview of the issues related to the use of paper backups in studies for which PRO data is collected electronically. Viable strategies to eliminate the necessity of a paper-backup system are provided.
Presenters: Cindy Howry, MS (.assisTek) and Paul O’Donohoe, MSc (Medidata Solutions)
This webinar provides a recommended framework for training end users, including site staff and study participants, on the use of ePRO technology in clinical trials. The goal of the webinar is to promote consistent and sufficient training prior to initiating data collection.
Presenters: Jenny J. Ly, PhD (ERT) and Serge Bodart, MSc (Bracket)
This webinar provides a recommended framework for the selection and evaluation of wearable devices and their measurements for use in regulatory trials to support labeling claims. The webinar will also address the essential properties of fit-for-purpose wearables and the activities required to establish clinical endpoints derived from data collected with wearable devices.
Presenters: Bill Byrom, PhD (ICON) and Chris Watson, PhD (ERT)
This webinar provides an overview of specific considerations related to allowing subjects to opt out of responding to individual items when PRO data collection is electronic as well as the relevance to other types of electronic clinical outcome assessments.
Presenter: Paul O’Donohoe, MS (CRF Health)
This webinar provides an overview of scientific and regulatory considerations when migrating paper-based patient-reported outcome (PRO) measures to electronic modes of data collection.
Presenters: Paul O’Donohoe, MS (CRF Health) and Willie Muehlhausen, DVM (ICON)
This webinar provides an overview of scientific, logistical, and regulatory considerations when using a BYOD approach to collect patient-reported outcome data in clinical trials.
Presenters: Jennifer Crager (YPrime) and Paul O’Donohoe, MS (CRF Health)
This webinar provides an overview of considerations in selecting the optimal ePRO modes, review best practices related to the deployment of ePRO systems, and discuss key items for ePRO deployment in clinical trials.
Presenters: Serge Bodart, MS (Biomedical Systems) and Elisa Holzbaur, BS, PMP (Almac)
This webinar provides a detailed description of the process for conducting paper to ePRO migration, mode-specific migrations, usability, feasibility and user acceptance testing as well as case studies of successful migrations.
Presenters: Serge Bodart, MSc (Biomedical Systems) Alisandra Johnson, BS (Bracket)
This webinar provides an overview of current ePRO data collection modes, the mode selection process, key considerations for selecting the most appropriate mode for a study and considerations for migrating an existing PRO instrument to an electronic mode.
Presenters: Cindy Howry, MS (YPrime) and Jennifer Ross, MPhilEd (Almac)
This webinar provides an overview of the ePRO Consortium, describes the various modes of PRO data capture, and discusses the trends in the collection of clinical data electronically.
Presenters: J. Jason Lundy, PhD (C-Path) and Valdo Arnera, MD (PHT Corp)
