We are pleased to announce an upcoming seminar series for ePRO beginning this September!
The collection of patient self-reported data is becoming increasingly important and, in some cases, a regulatory requirement in the assessment of safety and efficacy, and to determine labeling claims. Recent regulatory guidance and the introduction of the PRO and ePRO Consortia are helping to change the landscape with respect to patient self-reported data. Featuring both the sponsor and partner perspectives, join us to hear from industry experts on best practices and how to choose the best methodology as part of your future Patient Reported Outcomes strategy. This seminar will explore how sponsors and CROs can navigate the ePRO landscape from assessment planning right through to data submission.
Thus far, ERT has selected a few separate dates and locations throughout the US to bring the latest ePRO industry information to your backyard, at your convenience and entirely complimentary. The all encompassing agenda features: Validating a gold standard instrument for ePRO, a review of the latest ePRO Regulatory Guidance and an introduction to the C-Path Institute’s ePRO and PRO Consortia, PRO Scale Selection, ePRO Modality Selection, and Data integration.
The full agenda, as well as the official dates and locations are listed below.
8:00 – Continental Breakfast
8:30 – Keynote Address:
The Value of ePRO – The Patient’s, and Only the Patient’s Perspective
· 9:15 - A review of the latest ePRO Regulatory Guidance and an introduction to the C-Path Institute’s ePRO and PRO Consortia - How the latest guidance impacts on the entire suite of ePRO methodologies and the pros and cons of employing each within your trial.
· 10:00 – Break
· 10:15 - PRO Scale Selection - How to best plan for success in your studies with respect to selection of the optimal diaries, scales and assessments for collecting your patient self-report data. Hear from an sponsor about their experience of the do’s and don’ts and review a case study demonstrating the approach they have taken.
· 11:00 - ePRO Modality Selection - One size does not fit all when it comes to ePRO. How impartial consulting and a technology-agnostic approach to ePRO ensures that sponsors match the right solution with specific patient population demographics and geographic locations.
· 11:45 - Data integration - A review of the technical and operational process required to ensure that your ePRO data is seamlessly integrated within your eCRF.
· 12:30 – Lunch
Breakfast and lunch will be served at all locations.
We look forward to seeing you there!