Lisa Brooks, the Founder and Independent Consultant at Iris Statistical Computing, brings over 25 years of invaluable experience in drug and vaccine development to the biotech and pharmaceutical sectors. Her extensive background encompasses a deep understanding of regulatory affairs, particularly in the context of ensuring...
Lisa Brooks, the Founder and Independent Consultant at Iris Statistical Computing, brings over 25 years of invaluable experience in drug and vaccine development to the biotech and pharmaceutical sectors. Her extensive background encompasses a deep understanding of regulatory affairs, particularly in the context of ensuring quality and timely submissions to the FDA. At Iris Statistical Computing, Lisa leads a dedicated team focused on optimizing New Drug Applications (NDAs) and Biologics License Applications (BLAs). Her strategic consultation services are pivotal for clients navigating the complexities of eSubmission data packages, where precision and compliance are paramount.
One of Lisa's key projects involves the development and implementation of a proprietary checklist and process designed to evaluate CDISC data packages for submission readiness. This innovative approach not only streamlines the submission process but also significantly enhances the quality of data presented to regulatory bodies. By leveraging her expertise in SAS programming and Good Clinical Practice (GCP), Lisa ensures that her clients meet the stringent requirements set forth by the FDA, ultimately accelerating their path to market.
Lisa's proficiency in statistical analysis and her comprehensive understanding of electronic data capture (EDC) systems further bolster her ability to provide tailored solutions that address the unique challenges faced by biotech and pharmaceutical companies. Her commitment to excellence and her passion for advancing the life sciences industry make her a trusted partner for organizations seeking to navigate the intricate landscape of drug development and regulatory compliance. With a proven track record of success, Lisa Brooks continues to be a driving force in the field, empowering her clients to achieve their goals with confidence.
