Clinical Trials Support Systems

The Sigma Software team has solid experience working with companies in the healthcare sphere, meeting all strict industry quality and security standards. Our specialists have gained a deep understanding of the pharmaceutical business, including the specifics of clinical trials.

Our delivery meets international standards and regulations that apply to the companies and systems in the industry. We have delivered various solutions to our customers in this field, including clinical trial portals, turnkey solutions, content and document management systems, as well as web portals.

Selected Projects

Enhanced Patient Recruitment System
Customer: Well-known international pharmaceutical company
Industry: Healthcare
Solution Type: Web portal
Technologies: .NET, Web Services, AJAX, MS SQL Server 2005

Objective

Having produced two successful solutions for this well-known pharmaceutical company, which were delivered in cooperation with Sigma Solutions, Sigma Software was requested to develop an Enhanced Patient Recruitment System (EPR).

The EPR system is intended for centralized patient database management and analysis in order to define patients suitable and available for clinical studies for the customer's research. The goal of the project was to systemize and enhance the process of COPD patients' information gathering and recruiting for RITA studies (mostly PoC / PoP). This brings significant business benefits since the customer is able to speed up clinical studies and operate more efficiently on the market. The system is a centrally hosted web application serving several clinics in Europe and providing analysis interfaces for the customer's personnel.

Challenge

Since the application is developed for clinical personnel, the greatest challenge was to create user interfaces fulfilling the highest requirements for usability. In order to ensure that all expectations of end users are met, the project was performed using several steps of daily clinic processes analysis, prototyping (visual prototypes, clickable prototype), and meetings with clinic personnel onsite.

The project was developed offsite in 9 months, with short term visits of Sigma Software specialists, while maintaining a high level of internal and external security to meet the strict requirements of the customer.

System Description

The EPR is a secured web application operating via HTTPS protocol and accessible using one-time-password technologies. The system works as a web application accessed through IE browsers and developed as 3-tier architecture with presentation, business logic and data layers. The EPR is a clinic context-based system, so every clinic (entry point) is securely isolated from other clinics` data structures and data storage.

The system is built so that all user operations are tracked and logged and any change in the system is stored in the history so that any previous system state can be restored on demand.

System administrators (system-wide and clinic-wide) are able to configure the data structure for the patient database by adding new attributes with various data types, introducing business rules and relations between particular fields in a patient questionnaire. Thanks to high performance real time data synchronization mechanisms (SQL Server-based), the customer has up-to-date patient data collected from their clinics all over the world. The system also replaces analysis tools, helping the customer and clinic personnel to perform fast data searches and identify patients suitable for clinical studies.

Result

Today the system is used by several clinics in Sweden, Denmark, Finland, and the Netherlands. The Sigma Software team has finished the data import processes needed to put previously collected patient data into the system ready for the customer to start working with old and new patient databases using the new Enhanced Patient Recruitment System.

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Systems Integration Platform
Customer: Internationally-known pharmaceutical company
Industry: Healthcare
Solution Type: Web portal
Technologies: .NET, Web Services, AJAX, SQL Server 2005

Objective

As one of the world's leading pharmaceutical brands, the customer uses a System Integration Platform built on top of the WebSphere MQ server to connect a number of corporate systems together. The platform serves as a key repository for company information providing rich functionality for storage, maintenance, collaboration and search and is used by the customer's employees in different offices.

The first two versions of the Systems Integration Platform were built by the customer’s development team, but then the customer decided to outsource the development of version 3.0. Having met all of the customer's strict security requirements, Sigma Software, together with Sigma Solutions, was involved in the development of version 3.0 of the system. Having proved themselves as efficient and reliable suppliers, Sigma Software and Sigma Solutions have since also delivered version 4.0 of the platform.

Description

The business value of the Systems Integration Platform lies in its flexible design which allows easy system support and extension at minimal cost. The main challenge for this kind of application is to provide high performance of search operations. Due to excellent database design, the system brings the shortest response time for dynamic database applications. The platform runs a dynamic structure database and supports storage and retrieval features for data (including hyperlinks) that may currently be stored in a grid structure, e.g. a spreadsheet. The application provides comprehensive configuration interfaces for defining new entities, attributes, groups, lists and other information structures, which can be used immediately to manage data.

In order to make the platform even more convenient to use, Sigma Software usability experts analyzed the existing interfaces and suggested a number of enhancements which were implemented right away to facilitate managing data and make the process faster and easier.

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The Clinical Trial Portal
Customer: TranSenda International, LLC
Industry: Healthcare
Solution Type: Web portal
Technologies: TranSenda Business Process Manager (TBPM), Microsoft .NET, C#

TranSenda International provides modular software solutions for companies engaged in clinical trials. All TranSenda solutions are part of an integrated system — consisting of an underlying process-based platform and modular applications — called TranSenda Central®.

The Sigma Software team was involved as the integrator of a solution based on the TranSenda Business Process Manager (TBPM) platform. The purpose of the project was to develop a solution for automating the processing of the results of medicine investigation. The solution helped by replacing paper forms with the results of patient investigation.

The Clinical Trial Portal provides the ability to collect all information about patients on a single server. Thus any authorized person may analyze it immediately after it is saved into the DB. Once released, the Clinical Trial Portal was installed and is now used by 11 US institutions: Stanford University, UMD New Jersey, Benaroya Research Institute at Virginia Mason, The Center for Rheumatology (New York), Medical University of South Carolina, Johns Hopkins University, Denver Medical Center, the University of Texas, Boston University, the University of Connecticut and Duke University.

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