CYTO Asia 2017 -- In any laboratory, regulated or non-regulated, the inclusion of quality control samples in every analytical run is advantageous, but when considering longitudinal data, or multicenter data, quality control (QC) samples are critical.

CYTO Asia 2017 -- We discuss three representative case studies which highlight the importance of instrument-to-instrument standardization and the need for standardized application settings among instruments. Through case studies, we demonstrated that by employing the standardization process using hard dyed BD?

An emerging biotech company contracted Covance to run a Phase I clinical trial in the United States for a schizophrenia drug.

An emerging biotech company engaged Covance to manage three global Phase II clinical trials for treatment of lymphoma. The client requested the use of premium couriers to ship bone marrow and skin biopsy samples from sites in North America, Europe and Asia-Pacific to their U.S. testing facilities.

A pharmaceutical partner was developing a new treatment for women undergoing in vitro fertilization. Initially, the company had not included a companion diagnostic (CDx) in its clinical strategy, but as the clinical program progressed, it became clear that such a test would be necessary to seek regulatory approval.

A multinational in vitro diagnostic company (IVD) had developed a multi-analyte cerebral spinal fluid diagnostic panel with utility in identifying patients with early indications of both mild cognitive impairment and full-blown Alzheimer's disease.

Development of new therapies to treat rheumatoid arthritis (RA) shows no sign of waning. It is essential that studies are well designed, meticulously planned, include ongoing data surveillance and have a well-orchestrated patient recruitment strategy.

Despite the widespread availability of highly effective vaccines, chronic hepatitis B infection remains a major global health issue, and there are >350 million people chronically infected with the virus.

Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives.