Is it possible to get more efficiency in your conventional and specialty tests while maintaining ongoing quality? ISO 15189:2012 accreditation answers this question by delivering a comprehensive approach to quality management in medical, central and referral laboratories. Not only can these standards ensure quality, but they can reduce your risk of costly delays and ultimately save money in your trials.
“It’s no surprise that sponsors are concerned about the risk of regulatory findings and increasingly requesting ISO-accredited labs,” said Paul Kirchgraber, Vice President and Global General Manager at Covance Central Laboratory Services. “They need a demonstration of increasing quality—and savings—across their outsource vendors. Adopting ISO 15189:2012 is a powerful way to highlight our broad quality standards that meet or exceed their expectations.”
Advancing vaccine and novel immunotherapeutic development requires focused, specialized expertise. If you are looking to reveal more efficiencies in your vaccine and novel immunotherapeutic testing strategy, consider these three best practices:
1. Apply resources specifically tailored to your development
As you advance your vaccine or novel immunotherapeutic, it’s crucial to match solutions to your needs so you make the most of your efforts. Our dedicated vaccine and novel immunotherapeutic experts offer a consultative approach to determine exactly how to meet your requirements and accelerate your program. Co-located under the same roof, our scientists and study managers assign you a single point of contact to help simplify communications and decision-making so you can concentrate on the next steps. Continue reading
Companion diagnostics are evolving quickly as novel technologies emerge and new drug targets appear. Dr. Mark Roberts, Director of Diagnostics Development, recently shared his thoughts on the industry trends ahead of the World CDx Boston 2015.
How much progress has been made in the area of companion diagnostics? Continue reading
Testing drives drug development. From laboratory tests on patient specimens comes almost all of the clinical data needed for a new drug application. How and where those specimens are collected, transported, stored, and analyzed impacts the quality and usefulness of the data they produce. In the past, most tests were processed by local, academic, and specialized testing laboratories and coordinated by each investigator. However, centralized testing is becoming an accelerated trend – one that uses advanced technology and global operations to concentrate oncology clinical trial tests in a single, central laboratory.
The core value of a central lab is consistency. When local laboratories perform testing, their results will be different and results vary over the course of the trial. Central laboratory testing, on the other hand, offers ‘combinable data.’ The end product is that a result from a central laboratory is similar regardless of the global location where it originated from and the lab location where it is tested. At all of Covance’s central laboratories — in Indianapolis, Geneva, Singapore, Shanghai, and Tokyo — we generate data from the same analytical method platform, SOPs, equipment, reagents, and standards, eliminating variables that affect tests results. Continue reading