Ready, Set, GO!

Maximizing startup efficiency when time is of the essence By Kathryn E. Vinson, MS, CCRC We’ve all gotten in a hurry for various reasons. The alarm fails to go off; the car won’t start. In our rush to get to work on time, drop off the dog at the groomer, or pick up the kids […]

A Not So Risky Business

Understanding the complexities of Remote and Risk-Based Monitoring in a COVID-19 world By Kathryn E. Vinson, MS, CCRC At first glance, the terms “Remote Monitoring” and “Risk-Based Monitoring” can bring on anxiety to even the most seasoned professionals in clinical research. Despite the fact that the FDA and the EMA have had guidance posted for […]

The Elephant in the Room

Addressing Coronavirus concerns in clinical research By Kathryn E. Vinson, MS, CCRC I think it is fair to say that those of us in the healthcare world have mixed feelings about the novel Coronavirus (COVID-19). As healthcare and research professionals, we understand that healthy kids, teens, and adults are in low-risk categories when it comes […]

Personalized Cancer Vaccines

  Personalized Cancer Vaccines Although immunotherapy has been around since the late 1800’s with William Coley injecting tumors with live attenuated strains of Streptococcus pyogenes and Serratia marcescens, it went on the back burner as a treatment method due to fears of infecting immunocompromised individuals. It wasn’t until 1976 that immunotherapy once again became mainstream […]

Multi Tasking, What We’re Talking About This Week!

1.  The benefits of wearing many hats in clinical research In this industry, it is all about multi tasking and wearing many hats! Anyone seeking a consistent and predictable work environment would likely not pursue a career in clinical research. 2. Is US drug manufacturing homeward bound? Abi Millar looks into the US’s current pharma manufacturing […]

E-Consent – Is It Worth the Convenience?

As a former site research coordinator, when I think about the process of informed consent, my mind immediately flashes back almost 15 years to a large room with me standing at the podium. As I finish reading the interminable document aloud, I ask in my perky, fresh-out-of-college voice, “Okay, any questions?” Twenty pairs of glazed […]

Outsourcing Trends, What We’re Talking About This Week

1.  Outsourcing companies to see ‘significant investments’ from private equity Outsourcing companies are expected to witness “significant investments” from private equity and venture capital, despite decreasing investment in the overall healthcare industry. 2.  DNA computer brings ‘intelligent drugs’ a step closer Researchers have developed the first DNA computer capable of detecting several antibodies in the […]

Pediatric Clinical Trials, What We’re Talking About This Week

1. 3 Things to Consider when conducting Pediatric Clinical Trials Clinical Trials Arena  provides three considerations when conducting a pediatric clinical trial. 2. Are Clinical Trial Matching Services Truly Patient-Centric? Effective patient recruitment for clinical trials is critical to meeting timelines and budget goals, but the process of finding the right one, can be confusing. This article […]