Clients

Case Study 3
For a leading pharmaceutical software development company

Challenge
Improve the architecture of an established drug metabolism and pharmacokinetic (DMPK) laboratory information management system (LIMS) used by numerous pharmaceutical companies. Develop a process to import clinical study data provided by contract research organizations (CROs) into the system. Make the system fully compliant with 21 CFR Part 11.

Solution
  • Perform systems analysis and development of next generation drug metabolism and pharmacokinetic (DMPK) laboratory information management system (LIMS).
  • Design and implement new import functionality to allow pharmaceutical organizations to seamlessly integrate clinical data provided by contract research organizations (CROs).
  • Incorporate data auditing functionality into the system to comply with the FDA’s 21 CFR Part 11 regulation.
  • Rearchitect the system and the database and refactor code to improve system performance, reliability, and scalability.
  • Lead architecture review meetings and training sessions to transition domain knowledge and technical information to client’s staff.

Result
The latest version of the software incorporates new functionality including data integration capability requested by pharmaceutical companies and compliance with 21 CFR Part 11 and Good Laboratory Practices (GLP). The system is more scalable, more robust, and performs better than previous releases. Client’s staff have the knowledge needed to continue to support and enhance the product.



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