Clinical Trials Feature Articles

1. White Paper: ISO 21501 — A Standard Methodology To Optical Particle Counter Calibration And What It Means To Cleanroom Owners
   4/1/2013

   ISO 21501 is a new family of standards describing the instruments and calibration requirements for determining particle size distribution using light interaction methods. It represents the culmination of work by instrumentation manufacturers and industry users and comes at a critical time for the life science industry with the increasing trend for real-time air particle monitoring in cleanrooms using light scattering air particle counters. By Tony Harrison and Bob Latimer, Hach Ultra Analytics

2. Efficient Contracting Processes For Clinical Trials ... From The Legal Perspective
   1/27/2012
   On Dec. 1, 2011 in Cambridge, MA, law firm Pepper Hamilton’s Timothy Atkins, partner, life sciences, and Jason Reiser, associate, life sciences, gave a presentation as part of the firm’s Life Sciences Speaker Series. By Sara Gambrill
3. The Irish Department Of Agriculture Gains Improved Efficiencies And Strategic Information Management With Thermo Scientific Nautilus LIMS™
   12/11/2011
   The Irish Department of Agriculture, Fisheries and Food, Veterinary Laboratory Service (VLS) comprises the Central Veterinary Research Laboratory (CVRL) and the Meat Control Laboratory at Backweston in Kildare; The Brucellosis Laboratory in Cork and six stand-alone multidisciplinary Regional Veterinary Laboratories located in Athlone, Cork, Dublin, Kilkenny, Limerick and Sligo. Thermo Scientific Brand Products, Part of Thermo Fisher
4. The Evolving Role Of Pharmacovigilance
   12/11/2011
   New global regulations have forced the concept of pharmacovigilance to expand beyond just identifying adverse events. Today pharmacovigilance is on the minds of every pharma and bio executive, and it starts earlier in the drug development process. By Dan Schell, Life Science Leader magazine
5. Biobetters Q&A
   9/7/2011
   Biosimilars are seen in some non-U.S. countries as a “biologic generic.” They are intended to be identical to the originator biologic drugs.
6. Gene Expression Diagnostics: A New Approach
   8/1/2011
   How a gene expression diagnostics company successfully reinvented itself. By Suzanne Elvidge, contributing editor
7. Improving Water System Performance: A Continuous TOC Measurement Technology To Enhance Real-Time Process Control
   1/25/2011
   This article discusses real-time Total Organic Carbon (TOC) tracking in the water purification process and the importance of rapid, continuous, and reliable TOC monitoring for real-time critical water release. Submitted by Mettler-Toledo Thornton
8. Instrumentation For Product Control Vs. Process Control — Which Features Are Relevant For Monitoring High-Purity Pharmaceutical Water Systems?
   11/10/2010
   Conductivity measurements in high-purity water systems have sufficient measurement challenges, but the most misunderstood aspect is temperature compensation. By Dr. Anthony Bevilacqua, Mettler-Toledo Thornton
9. Technology Roundtable: EDC (Electronic Data Capture)
   11/10/2010
   How Do You Define EDC? Does It Start With An eCRF, Or Can It Start With A Physical CRF? By Dan Schell, Life Science Leader magazine
10. Safety First: The Impact Of New Regulations On Clinical Development
    8/25/2009
    A series of high-profile drug withdrawals in recent years has brought safety concerns to the fore, prompting more rigorous monitoring requirements from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). By ICON Clinical Research