Pharmaceutical Industry Solutions

KSM’s associates have delivered solutions for all phases of the drug development lifecycle, from compound screening through regulatory submissions. Our specialty is adapting agile software development methods and tools to deliver validated systems and processes.

Medical Coding System

KSM consolidated four disparate, internal-facing legacy systems into a single robust, secure, public-facing, web-based application for a top-5 pharma client. This system allows external resources to encode clinical data with standard diagnostic terms and medication names. The system supports encoding across standard (e.g., MedDRA) and custom dictionaries, and features built-in failure resolution capabilities. Engagement highlights include:

  • Designed the solution from the ground up using a lightweight Java enterprise stack (Stripes, Spring);
  • Deployed public web services for external systems to communicate with the internal system;
  • Implemented data warehouse to track and report against thousands of daily encoding transactions;
  • Implemented customizable AJAX web user interface for fast initial page loads and highly-responsive user interaction;
  • Automated 400 + system test scripts with the Selenium test framework, freeing testers from having to re-run test scripts for different browser configurations/versions.

Clinical Data Analysis and Reporting

KSM built, enhanced, and supported a web-based application suite that extends the validated “compliance envelope” to include the managed, monitored, and repeatable execution of data analysis macros. Users develop macros offline, upload them to the application, and execute them asynchronously against study datasets. The entire process, from import through reporting, is monitored and produces an audit trail proving the derivation of the results from the inputs and macros. The system supports a global user community, and has gone through three major releases over the past eight years to accommodate additional macro languages and data formats.

  • Defined and documented business and system requirements;
  • Developed both web-based (Java JEE) and Windows (C#) platform client applications;
  • Exposed core suite functions as web services using Apache Axis;
  • Introduced automated unit tests into a validated development process to accelerate regression tests;
  • Developed system test scripts per customer’s standards.

Request Management System

KSM designed and built a request management system for a top-10 pharma’s North American region. The system creates and manages requests for a variety of drug discovery activities, and supports dynamically adding new request types. Discovery scientists can monitor requests of interest to them, as well as modify, update and complete requests. The system allows discovery teams to work together effectively and provides a searchable history of requests for reference and reporting purposes

  • Employed a model-driven approach, generating XSDs and WSDLs from a UML model. The XSDs and WSDLs were inputs to Maven projects which converted them into service stubs and domain classes using the JAX-WS API.
  • Stored and retrieved all data from an Oracle database (10g), using a JPA/EclipseLink object/relational persistence layer.
  • Managed development team consisting of KSM, customer, and contractor personnel, using a modified version of Scrum adopted by the client.
  • Managed development team consisting of KSM, customer, and contractor personnel, using a modified version of Scrum adopted by the client.

Study Metadata Browser

This secure, web-based intranet application allows users to query and maintain current and completed study metadata. It consolidated data from multiple feeder applications, allowing the client to decommission those applications and streamline their workflow. This custom development project followed KSM’s agile methodology. Business users were fully engaged throughout development and testing, resulting in high user satisfaction with the finished product. The initial release of the system earned a 10 out of a possible 10 points on a post-production project evaluation. Other engagement highlights include:

  • Lightweight architecture for quick feature turnaround; users were testing functionality almost immediately after the start of development;
  • Replaced legacy Business Objects application user interface with web interface for improved performance, accessibility, and ease of use;
  • Migrated dataset storage from Oracle to filesystem-based repository for improved performance;
  • Automated unit and system testing using TestNG and Selenium.

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