NONMEM is a widely used application for population-based PK/PD analyses. The application offers limited output capabilities and subsequent data reduction and reporting can be tedious and time consuming. Nevertheless, the need to use results from modeling and simulation in support of the NDA submissions is on the rise. Additionally, FDA’s mandate on 21CFR-11compliance of all systems involved in the capture and handling of the data submitted puts organizations under greater risk of scrutiny. The iClinical: NONMEM workbench alleviates both of these problems. It reduces the grunt work involved in the assembly of input data, execution of the NONMEM run, extraction, analysis of results and assembly of reports, thereby, freeing up the modelers to focus on the science while ensuring end-to-end compliance as mandated by FDA. We plan to present a poster and demo the prototype of the workbench demonstrating its capabilities and looking forward to feed back from the user community.

INTEK Partners knows the drug development process. Our mission is to enable customers gain new knowledge through our systems and go beyond merely delivering data and/or information. INTEK has developed custom solutions from early through late stage drug development phases and have experience in delivering 21CFR-11 compliant solutions that take advantage of customers’ unique workflow and computing environment. Visit our website, http://www.intekpartners.com, for more details regarding our services and products, including examples of our data integration custom solutions.

Our new product, iClinical^TM, is an informatics solution spanning preclinical and clinical research, aimed at facilitating the analysis and decision making on new chemical entities (NCEs) based on pharmacokinetic, pharmacodynamic and clinical evaluations as they advance through the drug development process. iClinical is designed to enable scientists to maximize the value of PK/PD modeling and simulation technology, delivering real time integrated analysis-ready datasets, empowering key decision makers with timely access to analysis results both from lab and in Silico experiments and expediting FDA submissions via a 21CFR-11 compliant solution. Accessed through a series of workflow tools, the iClinical solution keeps the project team informed via email notifications, provides complete audit trail and can create views to data as it changes status (from preliminary to final). The solution is completely customizable to the workflow and analysis software of our customers (e.g., WinNonlin, R, SAS, SPLUS, NONMEM, PSN, etc.) and thus readily integrates into their environment. iClinical comprises of a centralized PK/PD Datamart, Master Data Repository, Data standardization, Data Merge Module, Workflow Manager, Analysis Data Pipeline and Web Reporting module.

For further information or to schedule a demo, please contact sales@intekpartners.com or stop by our booth at the 2006 PAGE meeting in Brugge.