Sunscreen, antiperspirants, toothpaste, penicillin, and shampoo … what do they all have in common? Did you guess that they each are regulated by the Food and Drug Administration (FDA)? You’re right. In fact, the Center for Drug Evaluation and Research (CDER) within FDA is responsible for the availability, efficacy, and safety of these and other prescription and over-the-counter drugs.
Many do not realize the importance of information technology in CDER’s responsibilities. For example, applications for new drugs are stored digitally. Field agents that inspect drug-making facilities capture information on mobile devices. Information on the results of laboratory, animal, and human tests are shared electronically. Patient reports on adverse drug events and reactions are received through online portals. The accessibility of this information–and more–is essential for the teams of scientists, statisticians, and reviewers that work at CDER.
As one might suspect, the software, hardware, and computing equipment used to manage CDER’s drug related information is not without cost. Whether petitioning Congress or collecting fees from Industry, Vergys works alongside CDER to secure the funding that keeps systems up and running. We also track budgets, schedules, performance, and user satisfaction metrics to ensure IT projects are delivered successfully – on time and on budget.
Our work isn’t confined to budget and project management. There’s tracking the system inventory, balancing the number of contractors bidding and supporting projects, and promoting adoption through change management and communication strategies.
With each funding request, project management metric, acquisition plan, or other requirement, Vergys is there to assist CDER with their short-term and long-term information technology needs. After all, we want safe and effective sunscreen, antiperspirants, toothpaste, penicillin, and shampoo on the shelves too!
Photo: A FDA scientist tests products marketed as dietary supplements, which may contain undisclosed and potentially dangerous ingredients.