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 surprise that the rapid pace of vaccine and treatment development for COVID-19 has received unprecedented attention in the press and on social media. While we all want effective prevention and therapies, Facebook, chat rooms, Twitter and other platforms are full of stories concerning the safety of these investigational new drugs or biologics. At the same time, the public and many professionals play the proverbial armchair quarterback with every new milestone announced or achieved. Given these lively discussions about clinical trials and the overwhelming interest in these developments, we here at DZS Clinical Services want to take a moment to discuss the strategies and capabilities of our dedicated pharmacovigilance team and their role on global clinical trial completions.
Risk Versus Benefit
In every decision-making process, whether its deciding to go out for dinner after work, to buy a new car, or whether to enroll in a clinical trial or take a pharmaceutical drug, all of us engage in benefit-risk analysis, even if we are not aware of it. In clinical research, the benefit-risk analysis is done by pharmacovigilance; it is the active monitoring of investigational new drugs and devices for possible adverse events and consequently for risks while comparing these to the potential benefits of the product being researched. Within this discipline are highly trained researchers, medical doctors, and statisticians (to name only a few) charged with adverse event attribution and general safety oversight.
The DZS Difference
At DZS Clinical Services, we are proud to offer an industry leading pharmacovigilance team that is prepared to assist the biopharmaceutical, medical device, cosmetic, and hospital industries with their safety monitoring needs. Our pharmacovigilance team is supported by a scalable, US-based, 24/7/365 live operated call center capable of handling medical information requests, adverse events, product quality complaints, reimbursement inquiries, counterfeit product information, and much more. Our call center is staffed with highly trained, multi-lingual professionals who are also up to date on the latest privacy regulations such as HIPPA and other global policies.
Armed with this data, the DZS Clinical Services pharmacovigilance and medical monitoring team is equipped to offer a full spectrum of services from single case processing to aggregate safety reporting, and from signal detection to NDA and IND submissions to name just a few.
As both a participant in multiple COVID-19 vaccine trials globally, and advisers to governmental and regulatory agencies worldwide, DZS Clinical Services is using its full power of clinical research expertise to help ensure the safety and efficacy of vaccine products utilized. In this great worldwide collaboration, DZS’ ability to facilitate multi-national safety monitoring and reporting has been vital in the fight to eradicate this disease. You can read more about our part in this project in “Immunizing Against Fear.”
For more information on the DZS Clinical Services pharmacovigilance and medical monitoring teams, please visit us today to find out how we can be Your Direct Line to Enhanced Safety Services.