They say there are two certainties in life: death and taxes. If we were to add a third certainty to that list, it might be that we generally have inflation as well. But if rising prices on consumer goods are a fact of life, why are some people surprised when the cost of prescription drugs increase as well?

When choosing a partner to participate in your human clinical trial, does it matter if you select a state- or federally chartered clinical facility versus a privately operated clinic or hospital? David Shuey, North America life sciences practice leader for insurance brokerage firm Willis Group Holdings plc., believes it does. In fact, if you are not aware of the differences, it could cost you dearly should a problem arise. The issue is sovereign immunity, an ancient carryover from England that is designed to protect the government from lawsuits.

Leslie Williams is President, CEO, and founder of ImmusanT, Inc., an early stage company focused on peptide treatments for auto-immune diseases. Williams has over 20 years of industry experience in healthcare, management, commercial product development and marketing. Williams took time out from her managerial duties to share her perceptions on outsourcing and working with CROs.

On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.

With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.

Today, 8 of the top 10 pharmas and 6 of the top 10 CROs use ARX’s CoSign® digital signature solution to help them benefit from fully electronic regulatory document lifecycles, compliance with various FDA GxP regulations, and efficiency in supporting audits.