Clinical Services & Medical Writing
Postmarketing studies define how products perform in real-world settings, exploring product strengths as well as safety issues. Health Decisions sets new standards for efficiency and innovation.
Increasing attention on how products perform in day-to-day circumstances reflects the recognition that development is not finished when a product reaches the market. Health Decisions believes that such work is both necessary and an opportunity – good science is good marketing.
Large studies (especially Large Simple Studies) should be designed to cast a wide net, defining both marketing advantages as well as safety concerns. Rather than limit such evaluations to a “phase III light” approach, our technology enables very large studies to be conducted at a modest cost, with the ability to dive deeper when issues of interest are identified (for example, nested case-control studies within a cohort). The same technology and ability to continuously monitor results as they are generated similarly enables us to quickly seize on issues of interest and turn them to marketing advantage, whether this is publicizing a competitive advantage or defining a group of users who should avoid a product. This focused approach enables far more useful studies that generate large amounts of data at a comparatively modest cost.
One example of Health Decisions’ innovation is with longitudinal studies that collect a wide range of information over time, including drug changes, reasons, and what patients do following changes. This approach has generated previously unstudied information that enabled a focused marketing approach addressing how a product is used and misused and allowing a greater focus on efforts to prevent discontinuation. Our technology (SmartPen and Optical Mark Read forms) allows large amounts of information to be collected simply, including directly from patients. The added ability to continuously monitor data as they are generated enables a far more flexible, response, and thoughtful approach to post-approval studies.
