From The Stage

Changing the Dialogue on CRO Communication: Responsiveness for Better Bioanalytical Results

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Lab Quality, CRO Selection

Because of the inherent complexities of large molecule bioanalysis, open communication throughout every study is vital to success. Ideally, there should be a constant stream of information flowing between the customer and the lab conducting their research, in order to proactively identify pitfalls, address potential challenges, and overcome issues before they cause project delays or compromised results. However, sponsors today still lack confidence in traditional CROs’ ability to communicate actively and cooperatively, as evidenced by the 2015 Contract Pharma survey where 46% of respondents cited poor communication as the biggest…

In Bioanalysis, Timing is Everything: Can Your CRO Keep Up with Your Innovation Demands?

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Lab Quality, CRO Selection

A 2015 survey from ISR Reports found that among the top metrics evaluated by sponsors when selecting a bioanalytical lab partner were turnaround time and on-time data and report delivery. This is logical in today’s fast-paced world of pharma and biotech innovation, where missed deadlines and timeline creep can not only compromise a competitive advantage, but delay the release of life-saving biologics to the market. And while a 2016 NiceInsight survey found that 50% of sponsor respondents said they would actually switch CROs based on lack of on-time delivery, the…

Where Expertise and Quality Converge: For CROs, One Isn’t Optimized without the Other

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Lab Quality, CRO Selection

When pharma and biotech organizations look to work with a CRO or bioanalytical lab, quality is always among the top priorities. In fact, a recent Nice Insight survey on outsourcing trends in 2016 found that 70% of respondents agreed that quality is the most important driver when selecting a CRO to partner with. But quality is not a single checkbox on the list of factors for CRO selection; rather, it is the collection of all attributes and capabilities that the CRO brings to the table, which enable quality to permeate…

Quality is More Than Good Laboratory Practice (GLP): Perspectives From an Advanced Quality Laboratory

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Lab Quality

Good Laboratory Practice (GLP). This term is far from new to the world of laboratory science. In fact, the initial development of GLP principles can be traced back to 1978, when the FDA released a set of guidelines intended to create a verifiable testing record in laboratory testing throughout the United States.Since then, GLP has become the industry’s touchstone for reliability and repeatability in the laboratory setting. Many point to GLP adherence as indicative of an advanced commitment to quality. Though related, the two are actually quite different.While an advanced…