Expert insights and opinions on clinical research and drug development.

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

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

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

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…

The European Medicines Agency (EMA) draft guidance released this past June on “computerized systems and electronic data in clinical trials” to replace their 2010 reflection paper on…

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…

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.  …

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

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

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