eCTD: Moving from Paper to Electronic

A compilation of recent notable news developments that pertain to the clinical trials industry.

Perspectives and insights regarding regulatory considerations when planning and conducting immunotherapy studies.

The increasing need for treatments to slow the global spread of COVID-19 has prompted greater cooperation between drug regulatory authorities around the world.

While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.

A first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.

Over the past few years, there has been significant growth in the use of more complex point of care laboratory devices.