Speaker Panel.  From left to right: Aline Cornelissen (Chiltern), Catherine Miller (Sera Prognostics) and Ben Baumann (OpenClinica).  Photo by Monika Vance (Santium).

SCDM Session 6 - ePRO: From Good to Great

Society for Clinical Data Management Annual Conference 2017
Ritz Carlton Grande Lakes, Orlando FL

On September 25th, 2017, Santium will join OpenClinica at the SCDM 2017 Annual Conference to explore challenges and experiences with migrating paper-based PROs and ClinRO measures to digital formats and cloud-based data collection platforms for clinical research purposes.

As patient-centric medicine and a focus on effectiveness continue to dominate the healthcare and research landscapes, patient-reported outcomes are becoming essential to the design and conduct of clinical trials.  Driven by demand from both payers and regulatory agencies, traditional methods of ePRO data collection (provisioned devices, existing instruments) are often costly, cumbersome, and fail to deliver the highest possible quality of outcomes data.

We must engage patients on their time, through their channels, in order to maximize the completeness, timeliness, and accuracy of reporting.

Our panel is a representative cross-section of seasoned trial leaders discussing how they pushed ePRO initiatives from good to great, by implementing “bring your own device” (BYOD) whenever possible and offering better training and support to study subjects when provisioned devices were necessary.


Santium explores this subject at SCDM 2017 panel session in collaboration with OpenClinica.

Monday, September 25, 2017
Ritz Carlton Grande Lakes
Ballroom V & VI
1:30 PM


OpenClinica logo


[embeddoc url=”http://www.santium.com/wp-content/uploads/2017/09/SCDM-2017-slides-for-ePRO-panel-session-22SEP17.pptx” viewer=”google”]


Ben Baumann

Co-Founder & COO

Session Chair

Aline Cornelissen

Manager, Data Technologies and Programming


Catherine Miller

Manager, Clinical Data Management
Sera Prognostics


Monika Vance

Founder & Managing Director



Learning Objectives

Understand the virtues and drawbacks of three modalities in collecting patient-reported outcomes: paper, provisioned device, and BYOD (“bring your own device”).

Gain knowledge on both long-standing and new regulatory considerations pertaining to electronic clinical outcome assessment (including ePRO).

Based on study processes and participant profile, evaluate the fitness of a BYOD approach to ePRO for any study incorporating patient-reported outcomes.

Session Level:  Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience

CDM Certification Competencies:  Electronic Data Collection, Clinical Trials Processes, Roles and Responsibilities, Processing External Data

Target Audience:  Study Data Manager, COA Lead, Regulatory Director

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