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-mak...

Artificial intelligence (AI) and machine learning are everywhere; intelligent internet and content searches that adapt to user preferences, automated personal assista...

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 ...

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 usually receive...

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 the other. This makes t...

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 a...

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

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 patient...

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 says that ...

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