Clinical Pharmacology & Pharmacometrics Vendor Oversight
Ensuring consistent, high-quality modeling and simulation deliverables can be challenging when outsourcing Clinical Pharmacology and Pharmacometrics work We will manage your external modeling and simulation partners, integrate scientific oversight, and streamline cross-functional collaboration.
Scientific Program Management & Process Optimization
We provide specialized oversight for the planning and execution of complex modeling and simulation programs. Our support includes defining scientifically aligned objectives, developing integrated project timelines, and proactively managing scope, risks, and resources. We can also help to identify and address operational bottlenecks, streamline workflows, and align processes with scientific and programmatic objectives to enable consistent, high-quality execution.
Strategic and Advisory Services
We provide expert review of NCA, PK-PD, PopPK, and PBPK analyses, including technical audits of models, reports, and related deliverables. Services include literature assessment, modeling strategy input, and critical review to support sound decision-making.
Customized Learning Solutions
Looking for tailored learning solutions in the areas of modeling and simulation, drug development, or other scientific disciplines? We can develop and deliver customized training programs, establish training infrastructure using Learning Management Systems (LMS), and create engaging scientific content for a diverse audience and background.
Testimonials
Why Clients Rely on Us
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.
Vice President
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.
Senior Director
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!
Executive Director
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