The US Food and Drug Administration (FDA) is seeking stakeholder input on the use of complex innovative designs (CIDs) in drug development and regulatory decision-making. …

Artificial intelligence (AI) and machine learning are everywhere; intelligent internet and content searches that adapt to user preferences, automated personal assistants like Alexa and Siri, …

The biopharmaceutical industry has a growing need for early-phase clinical studies in respiratory patients to support more advanced and informed “go/no-go” decisions in drug development, …

Gene therapy clinical trials differ in notable ways from other kinds of clinical trials. For one thing, patients in a typical Phase III clinical trial …

After release of the final draft of ICH E6 R2 in November 2016, the regulatory bodies started announcing the implementation of E6 R2 one after …

Amidst growing concern that the needs of women are being overlooked by academics and pharmaceutical companies, the FDA’s Office of Women’s Health (OWH) has released …

Given high costs and low success rates, risk mitigation strategies are critical in drug development. Pharmaceutical companies and investors are continually looking for ways to …

A recent study by researchers at McGill University’s Biomedical Ethics Unit found that one in five clinical trials is terminated for failing to recruit enough …

Evgeny Poltanov at Synergy discusses the CRO’s staff turnover and how anyone can guarantee a completely stable team when it comes to longer-term trials. He …

There has been considerable discussion about the concept of patientcentricity in the pharmaceutical community. The industry has taken a collective pause in an effort to …