From discovery to approval, the average lifecycle of a drug ranges from 10 to 15 years.
As the drug development lifecycle is streamlined, Information Management requirements become more complex. In addition, the Sarbanes-Oxley Act of 2002, which established new corporate governance and financial practice guidelines in the U.S., has also brought greater attention to the area of regulatory controls as well as financial compliance within the drug development process.
IMS Information Management Consulting is uniquely positioned to help clients address these challenges, particularly in the clinical trial management arena.
Clinical Trial Management
We support client projects encompassing the entire clinical trial management process. Our expertise lies in the area of process analysis...in our ability to translate business process needs into IM systems requirements - and in delivering solutions that turn these requirements into the right working processes with the right IM tools.
Our expertise includes:
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Improving trial planning, tracking and execution
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Recruitment planning and tracking
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Resource planning
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Budgeting
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Managing site and investigator data
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Generating KPIs
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Integrating systems, and leveraging information throughout the organization
Recent Information Management Consulting projects have addressed the following areas:
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Financial controlling and forecasting
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Planning and administration of European and local Health Authority reporting
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Managing patient data and site issues for GxP compliance
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Trial site monitoring
