Over the years we have seen some general confusion regarding the use of the FDA MedWatch 7-day report for fatal blood collection or transfusion reporting versus the standard 7-day alert requirement for FDA individual case safety reports from IND trials. Some of the safety systems that our company has worked with over the years do […]
Rodney Lemery
Dr. Rodney Lemery specializes in the implementation, support, and development of software used in the collection, management, and analysis of clinical data. His accomplishments as director of safety and pharmacovigilance at Perficient include the management of numerous clinical application implementation projects. In addition to his expertise in clinical and safety applications, Rodney is able to navigate between the technical and clinical worlds with ease due to his complementary educational background in epidemiology. He also holds a part-time professorship in the School of Health Sciences at Walden University, which solidifies his ability to lead global safety implementations at Perficient. Rodney has been with Perficient, via the acquisition of BioPharm Systems, since 2000. Prior to joining the company, he worked at Pfizer.
Blogs from this Author
Direct From The Pharmaceutical CEO To You The Consumer
What do our pharmaceutical product advertisements indicate about our national ideals, given the myriad of advertisements seen on the Internet, TV, in magazines, or heard on the radio here in the United States? Interestingly, the United States and New Zealand are the only developed nations that allow direct -to-consumer (DTC) advertising (Liang & Mackey, 2011). […]
3 Options for Migrating Safety and Pharmacovigilance Systems
Deciding “if, when or how” to move from one safety application to another can be a daunting task full of angst, pressure and fear of the unknown. Arguably, most of this distress is experienced in the initial analysis of the migration options and sifting through the solutions available to an organization. This blog entry will attempt […]
Should You Be Afraid Of Ebola?
With the recent localized outbreak of Ebola in West Africa, much information and disinformation has made its way to the Internet and mainstreamed media outlets. Given the foggy haze of reality, I thought it would be helpful to publish a summary of important facts – as the science currently supports – about Ebola: how it […]
The One Feature CROs and AROs Love in Argus Safety
Oracle’s Argus Safety is a comprehensive safety and pharmacovigilance platform designed to enable pharmaceutical, biotechnology, and medical device companies, in addition to contract research organizations (CROs) and academic institutions (AROs) to focus on product safety and regulatory compliance. With the multi-tenancy feature in Argus Safety, CROs and AROs can provide services to multiple sponsors, while […]
To Hull and Back – What a Trip!
My recent trip to a new client in Hull, United Kingdom, reminded me of a Harvard Business Review management tip that is hard to argue. It conveyed three ways to start your client relationship right to ensure success: Make an accurate first impression. Make them feel comfortable, but also set clear expectations about what you can […]
The Importance Of Interprofessional Education In Drug Safety
In recent years, we have seen many changes to the global “face” of product safety (FDA, 2009). Arguably, these changes modify the traditional focus of product safety from a case management and alert reporting strategy to include a more preventative, pharmacovigilance strategic focus. In order to successfully adopt these changes, it is critical that we […]