The Signal Expert insights and opinions on clinical research and drug development. Expert insights and opinions on clinical research and drug development. Category: eCOA Trial Optimization as the Focus for Decentralized Methods December 12, 2022 Signant Health Posted in eCOA Decentralized trials (DCT) tend to be associated with reduced site visits, but a more useful perspective is optimization – optimizing… Read More A Modular Approach to PROM Implementation – Reflections from ISPOR Europe 2022 December 8, 2022 Alexandra Kalpadakis-Smith, Bill Byrom Posted in eCOA Patient-reported outcome measures (PROMs) that measure health-related quality of life (HRQOL) in clinical trials are often composed of several different… Read More Computerized Adaptive Tests: A Primer December 1, 2022 Bill Byrom, Richard Sutherland Posted in eCOA Most patient-reported outcome measures (PROMs) are composed of a fixed number of items – that is, a question and its… Read More Prepare for These 4 Common Scale Management Challenges September 28, 2022 Karrie Crocco Posted in Clinical Operations Due to Signant’s extensive eCOA and scale management experience, we recognize that these processes can be unexpectedly complex, cumbersome, and… Read More 5 Tips for Electronically Migrating and Implementing ClinROs August 10, 2022 Dan DeBonis Posted in eCOA Filling in the Gap in eClinRO Guidance Nearly 15 years ago, the FDA first published its final guidance on migrating… Read More Innovation: Using Smartphone Sensors to Instrument At-Home Stair-Climbing Performance Tests August 3, 2022 Bill Byrom Posted in eCOA The drive to collect richer insights during drug development, and to optimize protocols by enabling more remote assessment with fewer… Read More With Sensors and Wearables, It’s Not All About the Hardware July 13, 2022 Cristina Rhoads Posted in eCOA The rapid adoption and incorporation of technology into many aspects of clinical research enables new opportunities to improve drug development…. Read More Patient-Reported Outcomes in Medical Device Trials – What We Can Learn From the FDA Guidance May 10, 2022 Bill Byrom Posted in eCOA Patient-reported outcomes data are increasingly collected in medical device clinical trials. In their strategic priorities document [1], the FDA’s Center… Read More Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies March 21, 2022 Bill Byrom Posted in eCOA Visual analogue scales (VASs) in clinical trials ask patients to mark a position on a horizontal line to reflect how… Read More Clinical Data Fraud: Detection & Mitigation Strategies January 5, 2022 Bill Byrom Posted in eCOA One of the most compelling arguments for using electronic data capture methods for patient-reported outcome assessments (ePRO) is the ability to ensure and demonstrate data integrity. Electronic data collection allows study teams to use… Read More 1 2 3 Next
Category: eCOA Trial Optimization as the Focus for Decentralized Methods December 12, 2022 Signant Health Posted in eCOA Decentralized trials (DCT) tend to be associated with reduced site visits, but a more useful perspective is optimization – optimizing… Read More A Modular Approach to PROM Implementation – Reflections from ISPOR Europe 2022 December 8, 2022 Alexandra Kalpadakis-Smith, Bill Byrom Posted in eCOA Patient-reported outcome measures (PROMs) that measure health-related quality of life (HRQOL) in clinical trials are often composed of several different… Read More Computerized Adaptive Tests: A Primer December 1, 2022 Bill Byrom, Richard Sutherland Posted in eCOA Most patient-reported outcome measures (PROMs) are composed of a fixed number of items – that is, a question and its… Read More Prepare for These 4 Common Scale Management Challenges September 28, 2022 Karrie Crocco Posted in Clinical Operations Due to Signant’s extensive eCOA and scale management experience, we recognize that these processes can be unexpectedly complex, cumbersome, and… Read More 5 Tips for Electronically Migrating and Implementing ClinROs August 10, 2022 Dan DeBonis Posted in eCOA Filling in the Gap in eClinRO Guidance Nearly 15 years ago, the FDA first published its final guidance on migrating… Read More Innovation: Using Smartphone Sensors to Instrument At-Home Stair-Climbing Performance Tests August 3, 2022 Bill Byrom Posted in eCOA The drive to collect richer insights during drug development, and to optimize protocols by enabling more remote assessment with fewer… Read More With Sensors and Wearables, It’s Not All About the Hardware July 13, 2022 Cristina Rhoads Posted in eCOA The rapid adoption and incorporation of technology into many aspects of clinical research enables new opportunities to improve drug development…. Read More Patient-Reported Outcomes in Medical Device Trials – What We Can Learn From the FDA Guidance May 10, 2022 Bill Byrom Posted in eCOA Patient-reported outcomes data are increasingly collected in medical device clinical trials. In their strategic priorities document [1], the FDA’s Center… Read More Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies March 21, 2022 Bill Byrom Posted in eCOA Visual analogue scales (VASs) in clinical trials ask patients to mark a position on a horizontal line to reflect how… Read More Clinical Data Fraud: Detection & Mitigation Strategies January 5, 2022 Bill Byrom Posted in eCOA One of the most compelling arguments for using electronic data capture methods for patient-reported outcome assessments (ePRO) is the ability to ensure and demonstrate data integrity. Electronic data collection allows study teams to use… Read More 1 2 3 Next