On 5 June 2018, a plenary session entitled ”Patient-Centric Specification” (PCS) was held at the 2018 ISPE Quality Manufacturing Conference in Arlington, Virginia. More than 160 professionals from worldwide innovator and generic pharmaceutical companies, academia, and regulatory agencies attended....
Being on the cutting edge of drug development is the goal of most pharmaceutical companies, but a new drug won’t work if the patient doesn’t take it. It’s a vexing problem that developers of healthcare technologies hope to address.
This article examines patient preferences in one facet of clinical research: the experience related to the use of investigational medicinal products (IMPs). As patients have become more involved and informed in their healthcare choices, the “voice of the patient” has been increasingly incorporated...
Making clinical trials more patient centric is among the many challenges facing the pharmaceutical industry. One method of improving the patient experience is by delivering study medication directly to patient homes, also known as Direct-to-Patient or...
The past two decades have changed the pharmaceutical sector and health care delivery in both developed and emerging economies. The increasing use of generic medicines globally, 1 the consolidation of manufacturing into centers of excellence—mainly in Asia—and evolution of supply chains have been...
Clinical trials becoming more complex and protocols are more demanding than ever. Long-term participation/commitment and frequent travel to investigator sites is a critical element for patient to decide if they want/can participate in a clinical...