Phase 1 Studies - Design and NCA

At Cognigen, we recognize that early clinical development is a critical stage in the R&D lifecycle. Phase 1 studies provide the first indications of a new drug’s pharmacokinetic and safety characteristics in humans, and they set the stage for the design of phase 2 and 3 clinical trials. Consequently, Cognigen understands that careful attention to the design and execution of phase 1 studies, to the analysis and interpretation of data, and to the preparation of reports are essential for successful drug development. Each study must be viewed as an integral part of the knowledge base that accumulates about a drug from discovery to registration. This knowledge base serves as the foundation for decision-making throughout the drug development process.

Cognigen’s 20 years of experience with many different compounds in various stages of development has taught us how interdisciplinary collaboration and a shared team vision can lead to successful development of a new drug. We encourage our clients to construct an interdisciplinary framework to synthesize current knowledge, emerging data, and hypotheses about the disease process and drug effects. This framework will support ongoing gap analyses that guide cost-effective experimental investigation plans, analytical strategies, and disease-drug models to address the gaps that are uncovered.

The pursuit of excellence is a strong tradition at Cognigen that is demonstrated in every interaction with our clients. Scientific excellence–asking the right question, then designing and conducting a valid study that answers that question and influences future research–is widely accepted as a benchmark for success in research. However, excellence of a more complicated sort is required to ensure the success of early drug development efforts. In this setting, there are at least three dimensions to excellence; namely, strategic excellence, operational excellence, and technical excellence.

Strategic excellence is demonstrated when knowledge about the disease and the drug are used to formulate study goals and objectives, to specify decision-criteria for near-term reviews, and to provide a rationale for proceeding with a development program.

Operational excellence is a result of careful study design, precise data selection and definition, and attention to detail in preparation of high-quality, error-free experimental results and study reports.

Technical excellence results when scientists use their training and experience to identify cross-disciplinary relationships in the data, formulate and test hypotheses, and accurately represent the data in management reviews.

Cognigen collaborates closely with each client to ensure excellence in every project. We listen, we ask questions, and we offer our expertise. Our deliverables reflect our commitment to the strategic, technical, and operational excellence of our work. The greatest compliment that Cognigen can receive is when “no questions” arise from a careful review of our work by our clients or regulatory authorities.  

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