Staying Vigilant with Pharmacovigilance

What is Pharmacovigilance? Medicinal products have transformed how we treat and prevent diseases, but they may also have unexpected side effects. As defined by the World Health Organization, Pharmacovigilance is the science and activity relating to the detection, assessment, and prevention of adverse effects or any other drug-related problem. It is a key way to […]

Site Monitoring in the Time of COVID

Remote monitoring in the spotlight By Maria Paluselli, MS, Project Manager and Medical Writer, DZS Clinical Services The COVID-19 pandemic has impacted nearly every facet of daily life, including conducting clinical research trials. Quarantines, site closures, travel limitations, supply chain for investigational product and necessary equipment, and the possibility of staff or study patients becoming […]

Less Pain for Adverse Events

New CDISC guidelines streamline AE and SAE reporting By Kathryn E. Vinson, MS, CCRC, with input from LeeAnn Phipps, PV Manager, DZS Clinical Services Nobody wants adverse events (AEs), much less serious adverse events (SAEs) to happen. The reasons that we in clinical research despise AEs are multitude, not the least of which is that […]

Teaching an Old Dog New Tricks

A look at the uptake of digital technologies in clinical research By Kathryn E. Vinson, MS, CCRC; Kari Brown; Siza Mphele and Dr. S. Govender In almost all fields, established professionals tend to do things the way they’ve always done them. Let’s be honest – it’s just human nature. While most site staff are comfortable […]

Quality Sites, Quality Trials

Managing quality at every step, DZS ensures industry leading results By Kathryn E. Vinson, MS, CCRC, with input from Karyn Thompson, QA Manager, DZS Clinical Services As the world becomes more and more focused on the clinical research industry with the long-awaited results of COVID vaccine trials, the importance of quality in research has taken […]

A Personal Touch

With dedicated Project Managers, DZS Clinical Services offers unparalleled service, responsiveness By Kathryn E. Vinson, MS, CCRC What if I were to tell you that there was a CRO where project managers knew more than just the indication and basic inclusion/exclusion criteria for their studies? Amazing, right? Now, what if I told you this CRO […]

The Pressure is on, but Safety First!

As COVID-19 vaccines and treatments reach late phase testing, pharmacovigilance takes center stage By Marta Simon, MD, LeeAnn Phipps, PhD, and Kathryn E. Vinson, MS, CCRC Without a doubt, never in our lifetime have we witnessed such a focus on pharmaceutical research. In the highly interconnected world that we live in, it comes as no […]

Fresh Out of the Gate

With brand new INDs, early phase development presents both excitement and challenges By Kathryn E. Vinson, MS, CCRC Early stage development of new drugs and devices is both thrilling and can be a little bit nerve racking. Like many of us in clinical research, my career began at the phase I clinic for a large, […]

A Global Approach

Partnering with researchers world-wide, DZS is on the forefront of disease eradication By Kathryn E. Vinson, MS, CCRC, and Siza Mphele Here at DZS, we have been honored to collaborate worldwide in vaccine trials against numerous infectious agents. This global experience puts us in a unique position of not only having worked with a multitude […]