| Clinical Trials System |
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Client
Sanofi Synthelabo, ranks among the top pharmaceutical manacturing companies in the world and is the second largest in France . It operates in over 100 countries.
Background
Clinical Trials are studies conducted for new drugs to be introduced into the market. These studies are conducted at a number of sites such as Hospitals and clinics by medical teams and are monitored by project teams from the pharmaceutical company who initiates these trials. The purpose of the clinical trials system is to record and track an enormous amount of project information for each study and site in order to manage these studies, to use it for regulatory purposes, to track investigators and their specialties and to manage payment to sites and patients.
Business Challenges
Sanofi had been using a Clinical Trials System that was developed with the Microsoft Access system (database & script). Since this system was being used by different sets of users, it was composed of separate modules for each of group, resulting in a lot of common data having to be duplicated.The system lacked a lot of flexibility in the way the business needed to be conducted. Further, due to restrictions in the development environment of Access, this system had been designed with a limitation of a fixed number records for many parts of the system.
Payments made by the company to the Hospitals and other institutions could not be tracked all the way down to the individual visit of each patient, resulting in having to depend on a separate sytem for this task.
There system ran on their internal LAN and while there was need for this to be accessed by their people from outside the company, this could not be done.
There was inadequate security built into the system, so a lot of information was exposed to individuals who should not have had access to it.
Our Solution
The clinical trials system was entirely redesigned from scratch to permit complete flexibility to conduct all aspects of the business. The business was analysed to determine various established standard practices that would provide the foundation for developing the new solution. The system was developed to capture information without restricting any of the business functions and to ensure access to every bit of information that would be useful to all groups of users. We redesigned the database which now has around 50 tables and has been fully normalized.
A high degree of flexibility was provided to allow efficient navigation and searching within the system and in reporting in addition to a much easier and intuitive user interface for the various users groups.
A number of new features were provided with the new system. For every Study and Site, CTA Issues, Labs, ICF Forms, CIB Receipts, 1572s, Sub Investigator CVs, REB Refusals & Protocol Amendments can be set up and tracked without the restrictions imposed earlier. Clinical resources, the people involved with the investigations, can be set up to allow each of them to have multiple addresses, with each center being set up to use appropriate address. CRA (Clinical Research Assistant) visits to individual sites are tracked to help in assigning them. Individual patient are now allowed to be enrolled for specific phases of the clinical trials and Invoices are created as well as payments are made on the basis of this. The application has around 50 screens now to enable all this functionality.
Security has been set up to restrict specific portions of the system, based on the role of each user.
Very comprehensive reporting has been provided as well as capability for mail merging of reports and documents to be sent to internal and external resources.
A maintenance plan was developed for regular database backups as well as a process for weekly data transfer between Oracle and SQL Server databases.
Addition functions that are being incorporated are:
- Web Services for Clinical Research Assistants and on the field users to access Clinical site data through a browser.
- Email Notifications
- Audit Trails for tracking changes.
Technology
We upgraded the database from the Microsoft Access to Microsoft SQL Server to use leading database technology. The database was modelled using Visio and all complex queries were developed with stored procedures. Data Migration was done using DTS packages and migration scripts. Optimized slow queries were used for complex analytical reporting.
The new system was developed with Microsoft .NET to take advantage of the latest development technologies. Web services will be provided to integrate with other systems. The application was developed using several common classes for reuse within the system. Database access layer classes were made use of to leverage current and future development work.
Benefits
The new system avoids all data redundancy as well as provide the maximum flexibility needed by Sanofi, and this in turn helps to reduce the cost of administration of this system. Further, managing of clinical trials is now easier, quicker, and more efficient.
The new database using SQL Server will improve the reliability, security as well as performance.
The use of .NET technology and Web Services will allow the company to interoperate and integrate with older systems, as well as permit employees to access this system over the web as well as from within the company.
The .NET architecture provides superior reliability, performance and security. The higher degree of object orientation with .NET will help in keeping the maintenance costs lower than otherwise.
Deployment of the new system throughout the company will be done centrally using a new technology so that updates carried out in one place will be automatically propagated to all the machines in the company, saving a large amount of periodic work.
Conclusion
The new system is being used to conduct over 100 clinical studies for new drugs and is being used by around 20 users within Sanofi’s office. When the web interface is completed, this system will be available to another 50 Clinical research assistants on the field who will access the system from over 100 sites where these trials are conducted. |
