Modoc Research will have an exhibit at the BIO Convention in Boston, MA from June 18-21.  Please stop by and visit us!  Our booth will be lo...

Medical data for a patient – entered directly into an electronic medical record (EMR) system, then entered into an eCRF, SDV carried out using E...

Have you ever wondered about what are FDA Guidelines surrounding laboratory certifications at a clinical site? As a monitor, it is most often see...

A new piece of legislation (S. Bill 296 – Preserving Access to Life Saving Medications Act) will require companies to notify the FDA 6 months in...

Over several weeks in March I had the unfortunate opportunity to spend time in a state-of-the-art heart and vascular center only to be followed by tim...

The shortage of injectable generic cancer drugs such as doxorubicin and cisplatin is reaching a critical stage.  While the FDA and manufacturer&r...

Welcome to the PharmaTalk Blog. With so much happening in our industry, on such a rapid scale, we find it critical to maintain an open communication ...

The value of a good resume is often overlooked. You may look at your resume and say “it got me the last job, it will get me the next.”   Well, don’t be too quick to believe that in today’s business environment. While those of us in clinical research may say we’re not in business, think again! We are all in the business of selling ourselves in a very competitive industry. The financial value of a good resume can be measured by the amount of time it takes you to get that next position or the increase in income that a well written resume can provide. What is a good resume worth to you?

Improperly obtained consent remains one of the most common sources of deficiencies noted during sponsor and FDA audits. We all have a clear expectation of what we hope to see upon review of consent documents at our investigative sites. Not only do we want the documentation to be executed properly, but we want to have confidence that true informed consent has actually been obtained. However, unfortunately, numerous issues still exist with obtaining informed consent.

Providing high quality data and meeting timelines set by sponsors and CROs are the ultimate goals in the identification of investigative site selection. The process by which sites are selected has traditionally followed a standard practice and set of criteria. Often, new sites are referred to a Sponsor for a trial and sites with whom sponsors have prior experience are approached regarding their interest in a trial. In addition, valuable feedback can be obtained from Clinical Research Professionals (CRPs), based on their prior experience working with a particular investigator and/or site staff. If available, assessment of audit findings, whether sponsor or FDA, is an important part of the site selection process and, as always, a debarment list should be carefully reviewed, as well as warning letters posted on the FDA web site.