New ways of doing business in a post-COVID world By Kathryn E. Vinson, MS, CCRC Clinical research can be thought of like the proverbial well-oiled machine. We have our processes and procedures that are tried and true. We are prepared for a multitude of contingencies – adverse events, non-compliance, and regulatory issues to name just […]
Rescue Me
Finding help when your study is in trouble can be tricky, but not impossible By Kathryn E. Vinson, MS, CCRC When we begin any new trial, we are all filled with joy and optimism that it will recruit quickly and efficiently. For the most part, in most trials, this is how it turns out. But […]
A Needle in the Haystack?
Partnering with the right CRO to maximize recruitment efficiency By Kathryn E. Vinson, MS, CCRC If you’ve worked in clinical research for almost any length of time, you have undoubtedly run up against the trial that feels impossible to recruit. Whether it’s a hypertension study with difficult inclusion criteria or an arthritis study that excludes […]
Timing is Everything
Evaluation of key performance indicators in the clinical research setting By Kathryn E. Vinson, MS, CCRC It has been said countless times in history that timing is everything. That phrase holds particular interest in the world of clinical research, wherein a difference of a day in reporting can mean the difference between being the first […]
In Vitro Diagnostics and Devices
Understanding the challenges of IVD development in a world dominated by drug names By Kathryn E. Vinson, MS, CCRC Our world is moving at an amazing pace. Despite the SARS-COV-2 pandemic, and in some respects as a direct result of the same, our needs in the medical community for new devices and diagnostic equipment have […]
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 […]
Implementing End-to-End Trial Technology Solutions
Greg Ambra, VP, Clinical Operations, was featured in a recent issue of CenterWatch Weekly, discussing the 21st Century Cures Act and electronic data issues facing the drug development industry.