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Case Studies
Portal for ECG Test Data Dissemination
Overview
A leading multinational helps drug companies analyze ECG patterns to determine if their drugs have helped patients. These analyses help the client's customers get the required background information that assists in getting approval from the FDA.
Business need
A portal [PDF] needed to be developed for the client to provide details of the ECG test data to stakeholders. The format for the data had to be based on a robust industry standard and made accessible to all the customers of the clients from remote locations. These customers wanted to study the ECG patterns before and after their drugs were administered to observe the effects and side effects that were experienced. Since drugs show different effects based on the intensity and duration of the trial, proper logging facilities had to be developed so that the drug companies knew about the impact of their drugs on heart patients over a period of time of usage.
Challenges
The client needed a system that was extremely robust. If a drug was discovered to cause side effects and those side effects were not captured by the system, then it would perhaps delay FDA certification. To ensure that this did not happen, critical parts of the system had to be tested to ensure that reliability was established beyond all doubt. To ensure all this, the following challenges had to be addressed:
- The client had to guarantee its customers full access to all the data that was generated from their tests.
- The users of the system would ultimately be cardiologists, who needed a system that was easy to learn and simple to use.
- As is the case with any multi-user scenario, login security was critical to data confidentiality.
- Logging was a key part of the system. The client and its customers needed to know exactly what data was being used, how and when.
- A standard protocol had to be used so that none of the client's customers faced problems relating to compatibility.
Infosys' Role
After a full analysis of the various issues involved, Infosys formulated a strategy that ensured that all the stakeholders-the client, its customers and the various expert users of the solution-could use the data gathered intelligently. Infosys' solution encompassed various data analysis tools to analyze the ECG readings. This helped both the client and its customers use the ECG data more easily and determine the drug's effect and the patients' response in a comprehensive manner. After careful analysis, Infosys adopted a standard called CDISC (Clinical Data Interchange Standards Consortium).
To ensure easy access, Infosys used Microsoft's .NET technology platform and relied on open standards like XML. The portal also permitted pharmaceutical companies to monitor the progress of trial ECG data from remote trial sites.
One of the best developments was a real-time ECG analyzer, which permitted pharmaceutical customers to analyze an ECG reading immediately and understand the implications of the trial study instantaneously.
Infosys also created an Issue Tracker that was designed to log, track and study all access to information.
Benefits
The Infosys solution helped the client by:
- Providing up-to-date information, which helped drug companies analyze the way their drugs were performing.
- FDA approval is a long and arduous process. The new system helped improve the workflow of submitting proof to the FDA.
- The drug companies and the client gained immeasurably in terms of competitive advantage thanks to the new rationalized system.
- Most of the earlier problems that had shown up during logging, tracking and monitoring disappeared because of the excellent implementation.
- Both online and offline work were enhanced, the former by the real-time analysis capabilities and the latter by the ability to download the data in the industry-standard CDISC format.
- In the long run, the new system will help in the creation of drugs that tackle heart attacks more effectively.
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