Monthly Archives: July 2010

Cato Research Presents at NC East SoCRA Chapter Meeting

Posted on 29 July 2010 by Meg Walz

Cato Research Regulatory Scientist Amber Barnes, PhD, RAC will be speaking on “Informed Consent Content and Process Requirements” at the August 2, 2010 meeting of the NC East Chapter of the Society of Clinical Research Associates (SoCRA). Dr. Barnes’ presentation … Continue reading →

Posted in Conferences and Meetings | 1 Comment

Generic Lovenox – Moving One Step Closer to Biosimilars

Posted on 27 July 2010 by Leo DiNapoli

We bleed from similar veins. – Tupac Shakur Lovenox is not, I repeat, not a biologic therapeutic.  It is derived from a biological source (pig intestines, yum), but it is not protein-based.  However, the FDA’s approval of a generic form … Continue reading →

Posted in FDA, Industry News | Tagged , , , , | 1 Comment

Statistical Implications of Protocol Amendments

Posted on 26 July 2010 by Ask-Cato.com Contributor

Clinical trial protocol amendments occur for good reasons. An unanticipated safety issue may arise, new information about the disease or treatment may suggest alterations, or recruitment and enrollment may not go as planned. One aspect of protocol amendments that often … Continue reading →

Posted in Clinical Trials, Statistics | Tagged , , | Comments Off

Webinar Slides – Nonclinical Drug Development

Posted on 23 July 2010 by Evan Richardson

Yesterday, Cato Research hosted a webinar titled, “Nonclinical Drug Development – A Successful Path Forward.”  Senior Toxicologist Sharon Daily, Ph.D. gave a very informative presentation that was followed by some great questions from the audience. As promised, the slides from … Continue reading →

Posted in Webinars | Tagged , , , | 1 Comment

HHS Proposes Changes to HIPAA

Posted on 21 July 2010 by Leo DiNapoli

Image via Wikipedia Privacy is not something that I’m merely entitled to; it’s an absolute prerequisite. – Marlon Brando On July 8th, the Department of Health and Human Services (HHS) announced that it was proposing changes to Health Insurance Portability … Continue reading →

Posted in FDA, Industry News | Tagged , , , | 2 Comments