Services

Our consultants combine their pharmacovigilance expertise with information technology to continually stay on top of current global regulations, business issues and trends in the industry to, in turn, help companies meet their best practices for drug safety. We offer support for all stages of the software implementation lifecycle.

Systems Validation Services

November Research Group has extensive experience working in a highly regulated environment. We understand the need to produce documented evidence to prove your pharmacovigilance system and associated processes function appropriately, and we appreciate that this must be accomplished while adhering to project budget and timelines.

We offer up-to-date Validation Kits for Oracle Argus and Oracle AERS, and accelerators that can be used to assist in the validation of any pharmacovigilance solution. We will work with your existing Quality organization to develop and execute validation materials in compliance with your existing SOPs, or help you develop a comprehensive validation framework for adopting mission-critical systems in a regulated environment. We will also work with you post-implementation to ensure your system remains in a validated state through decommissioning.

For more information, please contact November Research Group at info@novemberresearch.com.