Posts Tagged ‘clinical trials’

  “There are as many types of lung cancer as there are patients with lung cancer. We now understand lung cancer is unique to each patient and tailored treatments are more effective and less toxic. With the rapid developments being made in targeted treatment options available to patients with lung cancer, chemotherapy, radiation and surgery […]

A recent study published in American Academy of Pediatrics found that providing Asthma patients with medication before they left the hospital reduced ER re-admission rates, as opposed to the standard method of relying on patients to fill their own prescriptions. Medication adherence is a topic that we talk a lot about because of the significant impact […]

  Life sciences companies have long relied on paper-based business processes and been slow to adopt new technologies. The move toward electronic ways of doing business, specifically as it relates to clinical data, didn’t start to make headway until the late 1990s with the advent of electronic data capture (EDC) systems. It took over a […]

  We’ve written extensively about the many ways in which life sciences companies can leverage a clinical trial management system (CTMS) like ASCEND, Perficient’s pre-configured and enhanced version of Siebel Clinical. Why? Two reasons. For one, we are arguably the best implementer of Oracle Health Sciences applications for sponsors and CROs. And, two, ASCEND is […]

  Dr. Robert Califf, a cardiologist who has spent most of his career at Duke University, was confirmed by the Senate on February 24, 2016, to be the next FDA commissioner, following President Barack Obama’s nomination in September 2015. 

  While some of you might be hoping that RBM is just a trendy idea that we’ll soon forget, I have to say that when regulatory agencies take the time to draft and produce guidance documents on the topic… 

  According to an article in Clinical Leader that featured Bayer Healthcare’s VP Global Strategy & Development Advisor, by evaluating certain criteria against patient populations, electronic health record (EHR) systems can help sponsors determine trial feasibility and shape better study protocols. This can reduce the number of amendments, which can cost anywhere from $300,000 to […]

  When we think of compliance, we think of consistency. Compliance depends on following the same processes and procedures over and over, across the board. After all, that’s why we have all of those SOPs, right? When we’re used to conceptualizing compliance this way, the notion of risk-based monitoring can certainly lead to cognitive dissonance. […]

  Let me preface: this is just me playing devil’s advocate. To be fair. To give a different perspective. There is an exorbitant amount of conversation going on about the sharing and publication of all clinical trial data, good or bad. The reason? To help others out. To advance science. To save lives. 

  Efficiency and compliance are two critical components in highly-regulated industries, especially when it comes to developing drugs and medical devices. Unfortunately, though, these are two areas in which many life sciences companies struggle and could significantly improve through IT solutions. 

  Because risk-based monitoring does not involve 100% source data verification (SDV), unlike traditional monitoring, it’s understandable that RBM could seem sort of like “cheating.” But, research has shown that 100% SDV does not consistently result in higher quality data. In other words, the cost of 100% SDV outweighs the potential benefits. 

  Recruiting subjects for clinical trials has been a longstanding challenge for pharmaceutical and research organizations. According to Dr. Steven Alberts, Chair of Medical Oncology with the Mayo Clinic, only 5% of cancer patients ever enroll in a trial. On top of that, only a fraction of all trials ever finish enrolling enough patients on […]