DATATRAK International, a USA headquartered company, provides Electronic Data Capture services to pharmaceutical, biotechnology, and medical device industries. A worldwide ASP for the EDC industry, that delivers clinical research data from investigative sites to clinical trial sponsors faster and more efficiently than conventional, manual methods.

Details of Software projects carried out for DATATRAK are as under:

Data ETLR - Extract, Transfer, Load and Report

Project Brief

This project was executed for DATATRAK International; a USA headquartered company, which provides Electronic Data Capture services to pharmaceutical, biotechnology, and medical device industries. A worldwide ASP for the EDC industry, that delivers clinical research data from investigative sites to clinical trial sponsors faster and more efficiently than conventional, manual methods.

Focus of this project was to identify and extract data from diverse sources within DATATRAK, with a view to analyzing and making it available for billing and for improved decision making. The other important requirement was to ensure visibility and tractability of extracted data to ensure compliance with Section 404 of US federal law.

Project details

Data to be extracted was finalized jointly with the client. This data was available across 22 different sources and there were multiple data formats. Data interrelations in the source data were studied and understood. A database schema to store the extracted data was finalized. Thereafter, in consultation with the client team outputs to be generated from the extracted data were finalized.

Two specialized products, namely FDS Enterprise Application Integration Tool (FDS EAI) and FDS Business Intelligence Tool (FDS BIT), were used to execute this project.

FDS EAI was used for extraction and transfer of data. FDS EAI has full ETL capabilities and can be deployed to extract and transfer data from distributed and disparate data sources. It ensures that only valid data as per defined business rules is transferred. It also has features to map source and destination data dictionaries.

FDS BIT is the intelligent Report creation and rendering tool, which is capable of adapting to any third party application database with the help of its data dictionary. This tool provides great flexibility to the end user for analyzing and presenting the underlying data. FDS BIT made it possible to generate custom built reports that required cross table manipulation and multiple dimensions. Reports included consumptions, activity status and financial data represented in detail and summary formats. User could view outputs in a variety of formats like text, HTML or Excel.

Project was carried out on Microsoft platform entirely. Windows 2000 Server class machines were used for hosting Application Integration Tool and Business Intelligence Tool. ODBC drivers were used to establish connectivity to various data sources such as Oracle 9i, Sybase, MS Excel and SQL Server 2000.

FDS Application uses SQL Server 2000 as back end database. Web UI was built using ASP .Net. A separate Business logic layer was introduced. FDS EAI and FDS BIT used this layer for accessing data.

Appropriate use of store procedures and XMLs helped enhance the performance of the application.

MS Visio was used to record the data interrelationships.

Entire project was carried out in 25 man months over a period of 3-4 months.

Services ERP - Operations and Billing management system

Project Brief

This project was carried out for our Cleveland based client DATATRAK International, active in the area of electronic capture of medical trial data. This firm is an ASP (Application Services Provider), which offers applications for EDC (electronic data capture) as well as provides services for maintenance of trial data.

The objective of this assignment was to conceptualize, design, develop and build Services ERP an enterprise application to handle business transactions related to services, contracts and billing. Critical issues to be addressed were reliability, robustness, speed, visibility, tractability and consistency of data. Further, the project was to establish processes and practices, which comply with section 404 of US federal law.

Project Details

FDS Services ERP provides a backbone for all enterprise business processes ranging from contracts to billing. It establishes a standard for entering and maintaining data of contracts, services and change requests. The highlight of Services ERP application is the Project Tracking capability, which consolidates and presents data for consumption, billing and revenue. Services ERP is a closed loop system, which is directly linked to the current accounting system in use.

Services ERP was developed and deployed on Microsoft platform using SQL Server 2000 database. Web UI was built using ASP .Net and other third party tools such as Infragistic controls. Separate COM+ component layer was introduced which provides core business logic and performance enhancing routines.

Tools such as Rational Rose were used extensively during design and development stages. Knowledge transfer was attained using the MS SharePoint portal, which provides effective mechanisms of sharing data, documents, issues and requests.

Entire project was carried out in 25 person-months over a period of 5 months.

QA - EDC (Electronic Data Capture 4.0)

Project Brief

This project was carried out for DATATRAK International, based out of Cleveland , USA , active in the area of electronic capture of medical trial data. Primary project focus was to write test cases to cover all aspects of EDC version 4.0, develop an effective strategy for long term testing of the product and also revamp previous test cases to suit new requirements. This project also involved automation of critical functionality.

The project involved testing various modules. Extensive testing was done to ensure that the new UI is user friendly, easy to use and intuitive. The testing of the Import-Export functionality was performed. This required knowledge of various databases and technical know-how regarding import export techniques.

Project Details

EDC consists of various components, each one of them a complex software in itself. There is Data Entry and Review module, which is the GUI the clients interact with. Then you have a library design and study module used in the creation of complex forms used to capture patient data. The testing of this module involves a lot of complex logical steps to ensure that all sequences of various alternative actions provide accurate results.

FDS also had to ensure proper testing of the Report Export engine of EDC. This engine is used to create complex reports to ensure that the client is able to get a good overview of the data in the format desired. The testing of this report engine requires SQL knowledge. These reports are displayed using Crystal reports. Hence fundamental knowledge of Crystal reports is essential. The export engine exports data from the EDC database to other databases including SAS, as well as to other products such as Excel. Along with this export functionality, FDS also tested the Dataloader which is the import engine used to import data from various sources to the EDC database.

Technology Used:

Rational Tools were used in the testing process to ensure traceability, record test results and automate test cases. MS excel was used to write primary version of the test cases.

Test case automation was carried out using Rational Robot. Traceability between requirements and the test cases written had to be strictly maintained throughout the testing phase. All the requirements, bugs and their traceability were recorded and maintained using Rational RequisitePro and Rational ClearQuest. Analysis of test results was performed using Rational Test Manager.

An appropriate long term testing strategy was developed considering various testing techniques. Different testing methods such as Smoke tests, Regression testing, User Acceptability testing, Load testing and Performance testing were applied to ensure product quality.

Entire project was carried out in 50 man months over a period of one year.

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