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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.

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The recent draft guidance on “computerised systems and electronic data in clinical trials” published by EMA [1] provides useful perspective…

Get to Know the SME: Todd Feaster, PsyD.

In the first of this new series of Q&A interviews with Signant’s subject matter experts, we sat down with Todd…

2021 SCRS Global Site Solutions Summit Recap

This past week, Signant Health’s Chief Marketing Officer, Scott Connor, and Chief Operating Officer, Jason Martin, participated as panelists at…

ISCTM Autumn Conference 2021: Poster Presentations Roundup

The International Society for CNS Clinical Trials and Methods (ISCTM) hosted its 2021 Autumn Conference from Sept 30 – October…

eCOA Best Practices: Ensuring Timely Delivery of Translations

With more than half of all registered studies occurring in locations outside of the U.S. and the continued upward trajectory…

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.,…

eConsent Task Force Co-Chaired by Signant and Medidata Honored as Finalists for TOPRA Innovation Award

In 2019, a team of industry experts formed a task force to examine challenges and opportunities in the adoption of…

3 Reasons Oncology Studies Should Consider a Pre-Configured eCOA Solution

The FDA’s recent guidance placed an increased emphasis on patient-reported outcome measures (PROMs) for oncology trials. This data provides better insight into the patients’ disease-related symptoms, side effects of treatment, and effect…

EMA Draft Guidance: Here’s What It Tells Us About BYOD

The European Medicines Agency (EMA) draft guidance released this past June on “computerized systems and electronic data in clinical trials” to replace their 2010 reflection paper on…

Direct-to-Patient Clinical Supply Distribution: Everything You Need to Know

The adoption of decentralized studies has rapidly increased thanks in part to the recent pandemic, which encouraged regulators to permit more flexibility within protocols and forced sponsors to implement…