Case Study on Certara’s Simcyp PBPK Simulator to Eliminate Lengthy Clinical Trails

Abstract

Background/Purpose: Analysis and new interpretation of the existing information are equivalent to creating new knowledge. A case study is an example of exploratory research and allows researchers to analyze the available information using a systematic analysis framework. In this paper, a case study on a clinical research simulation software product called Simcyp is offered by a global company Certara to its clients in the pharmaceutical industry. Objective: To know the current status of model-based drug development simulation software, with special emphasis on Certara’s Simcyp software, its features, and variations, its client’s usage pattern to prepare new drugs, its usage in research and developmental contribution during the last 22 years, and analysis of Symcyp as a research division of Certara using SWOC framework and analysis of the Symcip as simulation software using ABCD analysis framework as stakeholder analysis. Design/Methodology/Approach: The case study uses an exploratory research approach where the information is collected from various sources including the company website, its competitor’s website, various magazine articles, and scholarly articles from Google Scholar. The collected information are analyzed systematically using company analysis frameworks, product analysis framework, SWOC analysis framework, and ABCD analysis framework. Findings/Result: Based on the analysis, it is found that Symcyp is a most admired simulation software in the pharmaceutical industry for model-based drug design and development for different varieties of diseases. The strategy of Simcyp division of Certara to satisfy, delight, and enlighten its clients is also discussed. Originality/Value: The case study is based on a systematic analysis of a software product of a company using company analysis frameworks, product analysis framework, SWOC analysis framework, and ABCD analysis framework thereby contributing to interpret the existing knowledge in a new way through new interpretation. Type of Paper: Academic research based case study.