Posts Tagged ‘CRO’

  As a big fan of efficiency, it pains me that most of us in life sciences still execute validation testing with pen and paper, present company included. All of those poor trees. All of that hand-cramping. All of that scanning. All of those migraine-inducing QA reviews in which we’re squeezing scanned test cases into […]

  The life sciences industry could learn a little something from Southwest Airlines’ “Transfarency” campaign, in terms of reporting clinical trial results. A recent investigation by the publication STAT found significant violations in the reporting of clinical trial results to the ClinicalTrials.gov database. Most academic research institutions, drug companies, and even the National Institutes of […]

  On December 17, 2015, the FDA issued a warning letter to Sun Pharmaceuticals Industries Ltd. in Gujarat, India. Sun Pharma’s website boasts that it is the “World’s 5th Largest Specialty Generic Pharmaceutical Company” with over 2,000 products in more than 150 markets across the globe. When an organization that large winds up with a […]

  Now that January is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in December – they’re ranked in order of popularity, with number one being the most viewed piece. 

  According to FierceCRO and a new report by HR+Survey Solutions, a quarter of clinical trial monitors in the U.S. are ditching their jobs for more lucrative ones. The 2016 CRO Industry Global Compensation and Turnover Survey report, which includes responses from 24 public and private contract research organizations (CROs), indicates that over the last […]

  For several years, the FDA has been the center of scrutiny for not having an official social media policy available on its website. According to the Union of Concerned Scientists, the FDA was the only one of 17 government agencies not to have social media policy…until now. 

  I came across this three-minute video from Quintiles, which brilliantly discusses their approach to risk-based monitoring (RBM) and gives viewers a look into a day-in-the-life of an RBM monitoring team. 

  I’ve written a number of blog posts on the challenges of clinical trial recruitment, and that’s for good reason. 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 complete […]

  These days, it appears as if most of the big contract research organizations (CROs) are using Siebel CTMS, Oracle’s clinical trial management system. In June of this year, I wrote about Quintiles’ use of Oracle Health Sciences applications, including Siebel CTMS. Now we’re talking about PPD, another top-5 CRO. 

  Let’s face it: Keeping clinical trials on schedule is not easy to do. Whether a sponsor runs into issues with quality, timeline, personnel, or myriad other things with an outsourced partner, it’s crucial to address the problems as soon as they’re identified. There are a few routes a sponsor can take when a study […]

  I’m sitting at my desk thinking to myself: Why don’t I see many ads trying to recruit patients for clinical trials? “Many” is actually an overstatement. I rarely see them. Anywhere. And that’s a problem. I’m fairly healthy, but I have some issues. I’m slowing balding. I suffer from heartburn. Sometimes, I have debilitating […]

  One question we often get relates to disabling Oracle Clinical (OC) and Remote Data Capture (RDC) accounts. What happens to the OC/RDC accounts of users who separate from a company or roll off of a clinical trial? The answer is relatively simple, though not necessarily obvious, because the only way to tell if an […]