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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.

EMA Draft Guidance: Here’s What It Tells Us About BYOD

The European Medicines Agency (EMA) draft guidance released this past June on “computerized systems and electronic data in clinical trials” to replace their 2010 reflection paper on…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

The Inaugural IMAGINE FORUM Recap

At Signant Health, we believe progress is best done together. That’s why we launched the Imagine Forum to promote industry-wide collaboration and thoughtful discussion.  …

AAIC 2021 Recap

Here are a few takeaways from Signant’s presentations that you may have missed: Dr. Miller led a product showcase, Glimmers…

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…

Best Practices: RTSM Strategies to Avoid Partially Unblinding Clinical Trials

Randomization and Trial Supply Management (RTSM) solutions are routinely used in today’s clinical trials to manage randomization, enable emergency code break to…

Analytics Approaches to Assessing Clinical Endpoint Data Consistency

Clinical research sponsors collect more data on more endpoints than ever before, especially since the proliferation of remote/decentralized clinical trials. From…

Preparing Study Staff, Sites, and Patients for Remote Video Assessments and Consultations

With the proliferation and widespread acceptance of telemedicine solutions in clinical research, it is imperative to properly prepare everyone involved in a study to…

Clinical Research Technology Comparison: Telemedicine Versus Video Conferencing for Healthcare

Telemedicine or telehealth solutions may not be new, but virtual video visits are becoming more common for communication between patients and healthcare providers thanks to COVID-19. In clinical trials, the application of telemedicine technology is still evolving. Clinical trials have far…