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POST-MARKETING STUDIES

Clinical research does not end once a product has been placed on the market. Patient experience and the analysis of post-marketing data can provide valuable information to support safety and efficacy, and allow the consolidation product claims, perhaps needed to obtain reimbursement. It can also provide physicians with comprehensive and up-to-date information on the product's safe and effective use.

In addition, well-designed and conducted post-marketing studies can generate high quality scientific information that can be published and used to create medical awareness and clinical guidelines.

Unlike studies used for registration purposes, which must meet strict regulatory requirements, post-marketing studies can be conducted with more flexibility and freedom in the choice of scientific objectives. Furthermore, whilst these studies must comply with the principles of GCP, they do not need to comply with some of the formal procedures that are often required by regulatory agencies, and therefore can be less costly and quicker.

Donawa Lifescience Consulting (DLC) can help your company to:

• Organize and manage an effective post-marketing surveillance program
• Handle adverse reactions, product recalls and medico-legal cases caused by adverse device reactions
• Design and manage post-marketing clinical studies
• Write study protocols that address key clinical and commercial questions
• Obtain information from the study that will aid in proper product positioning or provide additional marketing opportunities
• Manage the sometimes difficult challenge of investigator-generated studies
• Launch or re-launch a product by targeting opinion leaders to act as investigators in important markets
• Generate clinical evidence as a contribution to successful marketing
• Publish results in specialized medical journals

Please contact us for further information or assistance.