COVID-19 has dominated our lives for two years now. Although we are returning to a new normal, with the help of rapidly developed vaccines, do …

Through its issuance of recommendations and regulatory decisions concerning medical products, the US Food and Drug Administration (FDA) typically considers the “unmet medical need” surrounding …

As the world continues to adapt to the impact of the pandemic, a legacy has seen the evolvement of varying approaches to how clinical trials …

Each year, on the 20th of May, the global health community celebrates International Clinical Trials Day, the anniversary of James Lind’s famous scurvy experiment in …

Sample size has always been one of the first design choices a medical device sponsor has to make for a clinical study. But the calculation …

Stakeholders across the life sciences industry now understand that data is more important than documents but also that it’s crucial that the data is reliable …

The successful execution of international clinical trials requires the involvement of service providers adhering to a wide range of regulatory guidelines and industry standards including …

The subject of Regenerative Medicine is currently at an inflexion point. There has been an enormous amount of financial investment, along with basic and clinical …

Epilepsy is one of the most common and disabling chronic neurologic disorders that affects more than 50 million people worldwide. Despite the current of over …

Acute Myeloid Leukaemia (AML) is a blood cancer characterised by the overproduction of immature white blood cells in the bone marrow. These proliferating immature cells …