We believe that before we answer the challenge of "what to do with data" we have to answer "how to go about with data". Because "where is the data" is as critical as knowing what is there in the data. In short, information.

That is one of the primary reasons our Data Management system activities are run on globally proven and specialised software like Oracle Clinical 4.5, Oracle Thesaurus Management System with MedDRA dictionary and SAS. To ensure that our data management capabilities meet stringent quality standards, we validate our clinical databases and software in compliance with the regulatory bodies and 21 CFR part 11 environments. But we didn't just stop at the customary, we run our systems through Infosys Technologies, one of the world's foremost IT services company, for validation and documentation as per 21 CFR guidelines.

While we ensure that the machines do their job par excellence, we have a team of equally brilliant minds who know how to bring out the best, working on the software. In addition, with years of experience on working with all stages of data management and technologies, our team members are thoroughly familiar with the sponsor's processes and procedures that they retain and retrieve as knowledge from early-study phases as products move through development. One of the reasons, that when needed we are ready to offer flexible data management systems with customisation capabilities according to the project and sponsor requirements.

Services under Data Management include:

• Case report form design and Review
• Data management plan
• Database setup & validation
• Double data entry
• CRF Log and Tracking
• Clinical Data Review
• Query Management
• Interim Analysis
• Coding in MedDRA
• SAS programming
• QC check
• Database lock

Services under Analysis include:

• Statistical analysis plan
• Statistical analysis
• Statistical tables
• Statistical report writing