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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

Decentralized trials (DCT) tend to be associated with reduced site visits, but a more useful perspective is optimization – optimizing…

A Modular Approach to PROM Implementation – Reflections from ISPOR Europe 2022

Patient-reported outcome measures (PROMs) that measure health-related quality of life (HRQOL) in clinical trials are often composed of several different…

Computerized Adaptive Tests: A Primer

Most patient-reported outcome measures (PROMs) are composed of a fixed number of items – that is, a question and its…

Prepare for These 4 Common Scale Management Challenges

Due to Signant’s extensive eCOA and scale management experience, we recognize that these processes can be unexpectedly complex, cumbersome, and…

5 Tips for Electronically Migrating and Implementing ClinROs

Filling in the Gap in eClinRO Guidance Nearly 15 years ago, the FDA first published its final guidance on migrating…

Innovation: Using Smartphone Sensors to Instrument At-Home Stair-Climbing Performance Tests

The drive to collect richer insights during drug development, and to optimize protocols by enabling more remote assessment with fewer…

With Sensors and Wearables, It’s Not All About the Hardware

The rapid adoption and incorporation of technology into many aspects of clinical research enables new opportunities to improve drug development….

Patient-Reported Outcomes in Medical Device Trials – What We Can Learn From the FDA Guidance

Patient-reported outcomes data are increasingly collected in medical device clinical trials. In their strategic priorities document [1], the FDA’s Center…

Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies

Visual analogue scales (VASs) in clinical trials ask patients to mark a position on a horizontal line to reflect how…

Clinical Data Fraud: Detection & Mitigation Strategies

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…