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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.

Author: Bill Byrom

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…

The Center for Drug Evaluation’s (CDE) draft PRO guidance

In the landscape of rapidly growing numbers of pharmaceutical clinical trials in China, the Chinese Center for Drug Evaluation (CDE)…

What are the best practices for handling changes to ePRO data?

The recent draft guidance on “computerised systems and electronic data in clinical trials” published by EMA [1] provides useful perspective…

Selecting a Fit-For-Purpose Device

In today’s protocols, we continue to see an increased appetite to study clinical endpoints derived from wearables and sensors (i.e.,…

EMA Draft Guidance: Here’s What It Tells Us About BYOD

The European Medicines Agency (EMA) draft guidance released this past June on “computerized systems and electronic data in clinical trials” to replace their 2010 reflection paper on…

Key Technology Elements for Successful Hybrid Trials

As the industry continues to predict and debate what the “new normal” in clinical development will look like in an…

Mixing eCOA Modes: How to Respond Post-COVID Mitigation

Over the early months of the pandemic, we worked with clients to implement mitigations for studies that continued but were…

Five Considerations for BYOD Studies

In our drive to make trial participation simpler, a bring-your-own-device (BYOD) model is thought to be a convenient approach for trial participants to complete patient-reported outcome…

Leveraging Today’s Technologies to Improve Clinical Research

Fully remote and hybrid trial methodologies promise to accelerate clinical research and make study participation more convenient through greater digitization….