We are seeing more and more imaging trial protocols requiring the analysis of subject eligibility to occur under tightening deadlines. Take for example a cardiovascular study using centralized analysis of an Intra-Vascular Ultrasound (IVUS) to determine whether a subject should be included in the trial. In...

Clinical trial sponsors have focused for years on finding the right investigators who can recruit patients, and choosing the best core laboratories to do the necessary data analysis. Without a doubt, having the best thought leaders associated with a trial can increase the level of...

In the world of clinical trials, we are constantly reminded of national privacy regulations and 21 CFR Part 11 restrictions when using electronic means to submit medical imaging data. National regulations (NRs) include the European Union Directive on Data Privacy, The Canadian Personal Information Protection...

Clinical trials are inherently risk management exercises, where sponsors, CROs and investigators work as a team to determine the effectiveness of a compound or treatment. In the late 1900s, form data submitted by investigators to CROs was sent using the latest in technology: fax. Prior...

In 2011, Forbes published a somewhat startling article about HIPAA violations in the U.S. The gist  of the piece is that violations are occurring more than one might think, that data that people consider to be non-confidential details are in fact protected by law, and...

In an interesting interview in Bio.IT World, Glen DeVries, president of Medidata Solutions, spoke about the evolution of clinical trial processes and how we’re inevitably going toward cloud solutions. I couldn’t agree more. As Glen points out, we’ve seen this phenomenon across a multitude of...

As we all know, investigator sites around the world are the most important partners a sponsor or a lab can have in their quest to determine the efficacy of new therapies. Investigator sites are small groups of committed researchers and trial coordinators who are dedicated...

An Operations Project Manager at AG Mednet oversees the customization and deployment of AG Mednet’s exam processing and submission technology to its core lab and pharmaceutical/device customers. The set-up of AG Mednet software for an imaging clinical trial begins with a requirements-gathering process for the...

Clinical trials involving imaging endpoints produce significant amounts of digital data. If you compare an imaging trial with one that doesn’t collect medical images, the amount of bits and bytes sent from investigator sites in the former increase by multiple orders of magnitude. While everyone...

A report by the Tufts Center for the Study of Drug Development claims it costs $2.6 billion to develop a drug over the course of more than a decade. When the Center conducted the same research in 2003, it cost an estimated $802 million to develop a drug -- or the...