BioAnalytical Laboratories Featured Articles

11. Five P's For A Productive CRO Relationship 9/18/2015

    You have done the research and selected a CRO that looks like it can meet all your research needs. Now you are about to entrust your precious samples to a team of people you may barely know. How do you safeguard your research, meet your timelines, and develop a productive working relationship with your CRO? Few things are less stressful than managing these relationships. A good CRO can bring your project in on time, meet all regulatory requirements, and do so with the level of quality you expect. Unfortunately, choosing the wrong CRO can result in delays, poor quality, and the feeling that you have a CRO that will require constant monitoring and hand-holding.

12. WIB Profile: CROs Must Have The Ability To Deliver 9/3/2015

    Zhaoqing (Ching) Ding has been involved with the sciences for more than 15 years. She earned a B.S. in Microbiology and a M.S. in Immunology, both from the University of California, San Diego. She then earned a Ph.D. in Immunology from the Stanford University School of Medicine before rounding out her education by attending the program in Innovation and Entrepreneurship from the Stanford University Graduate School of Business. She started her career performing research in academia before joining The Janssen Pharmaceutical Companies of Johnson & Johnson as a scientist in 2013. In this WIB profile article she shares her experience in working in academia versus pharma, the challenges of working with CROs, and the future potential of biotherapeutics.

13. Is The Sunshine Act Reducing Clinical Research Spending? 8/24/2015

    The intentions behind the passing of the Physicians Payment Sunshine Act were good. The Act required manufacturers of covered drugs, devices, biological products, and medical supplies to annually report to the Centers for Medicare & Medicaid Services (CMS) information regarding payments, ownership, investment interests, and other transfers of value to physicians and teaching hospitals. The intent was to reveal any conflicts of interest that might exist, with the end goal of hopefully bringing down healthcare costs. But even the most well-intentioned acts can have unforeseeable negative results. And it now seems the well-intentioned Sunshine Act may be having the unintended consequence of cutting down on the amount of investment making its way into clinical trials.

14. Responding To Market Volatility In The Clinical Space 11/15/2012

    At the 2012 AAPS meeting in Chicago, Clinical Leader sat down with Chad Briscoe, Ph.D., senior director of PRA’s Bioanalytical Laboratory in Lenexa, KS. Briscoe took time out to share his insights on strategic partnering and how PRA’s expansion of services is being driven by market demand.

15. Successful Bioanalysis Outsourcing In Support Of Drug Development Program: Key To Risk Mitigation Planning For Mid-Study Method Transfer 9/15/2011
    We have developed processes to enable consistent method performance during method transfer. This has ensured timely method transfer validation and study sample analysis in support of new drug development and product commercialization.