Non-interventional or observational studies create new opportunities for pharmaceutical companies to enhance their drug benefit plans with meaningful data on the real world value of their products. This data can bring a host of benefits:

• Identify the true cost/benefit of a treatment
• Highlight particular patient groups where a product will succeed
• Support safety reporting
• Build a stronger value case to support reimbursement activities
• Obtain a new level of data around products to give greater competitive advantage

Why an EDC solution is needed for non-interventional studies

The structure and nature of non-interventional studies differs significantly from the clinical trials process; different tools are required to support data capture and analysis.  Data capture systems for non-interventional studies need to be quick to implement and easy to use for non-expert users from day one.  The most effective EDC systems are:

• Developed as Web-based platforms which are system-light for quick and easy implementation.
• Designed with Web 2.0 intuitive interfaces that are easy to customise, simple to use for doctors and patients alike, and drive new collaboration opportunities.
• Able to provide a secure and sophisticated communications platform that requires little user training.
• Able to provide new levels of on-demand data access and analysis to all involved in the study.

The cisiv solution

Cisiv has built Baseline Plus, an EDC solution designed specifically for the unique data requirements of non-interventional studies. To find out more about cisiv’s experience in both small and large, local and international studies and how we can help you plan your next project, please contact us.