We know that diversity in our companies and communities brings a wealth of varied experiences and points of view. Did you know that diversity is also essential in clinical trials? One goal of a clinical trial is to represent the whole population within a disease state. Effectiveness, side effects and even performance of a device […]
ICH E6(R3) Revisions: Is Your Team Ready for the Coming Changes?
ICH E6(R3) Revisions: Is Your Team Ready for the Coming Changes? With potential changes in the design and development process on the horizon, we discuss the upcoming ICH E6(R3) revisions and the impact on clinical research A Look Back at Revision Two In 2016, ICH E6(R2) was introduced, focusing on trial participant protections and […]
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 […]
Webinar: How CROs and Sponsors Improve TMF Management with a Shared eTMF
How CROs and Sponsors Improve TMF Management with a Shared eTMF For biotech, pharma and medical device sponsors considering TMF Management as an area where greater efficiency and transparency would be beneficial for your studies, DZS Clinical Services and Agatha partner in welcoming you to watch our recent webinar. The Trial Master File (TMF) is […]
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 […]