Your Partner in Advancing Drug Development with Integrity and Efficiency

Denise was pulled in to support the analysis and interpretation of the PK/PD outcomes for one of our studies. She immersed herself in the data and embraced the team dynamics. Throughout this multi-stakeholder collaboration, she was able to help us prioritize the key PK/PD responses, determine the most effective method to display the differences across treatment groups, and provide the text to ensure the messaging was clear. As a bonus, despite supporting multiple clients she was readily available for calls and never missed a deadline.

Denise is a thorough professional with a grand vision for her function, her team, and the broader organization. She’s perhaps one of the most organized and articulate people you will ever meet. She’s highly knowledgeable on all things modeling & simulation from all facets, including Pharma, CRO, and Regulatory – which allows her to have tremendous empathy towards whomever she’s engaged with. She has always offered me great advice on improving things, creating processes around them, and more. I enjoyed every moment of working with her.

We hired Denise to evaluate a population PK model that was done by another vendor and rejected by the FDA without much context. She dug into the model and provided an unbiased assessment of its gaps from a regulatory and technical perspective to help us understand its deficiencies. We were so impressed with her work that we asked her to lead our popPK and PK/PD strategy to support Phase 2b dose selection. She helped us select an appropriate vendor, proposed a strategy that was within budget and phase-appropriate, and provided rigorous oversight of model development and execution while ensuring our team’s feedback was incorporated. She managed multiple pivots and worked closely with the vendor to deliver high quality work in record time. We would not have achieved success without her support!