Postmarket Required Studies and Surveillance
Real-time monitoring of prescription drug use and abuse with sentinel, high-risk populations ensure state-of-the-art pharmacovigilance and rapid detection of unanticipated outcomes
Custom Scientific and Epidemiological Studies
We work closely with clients to tailor exploratory or hypothesis-driven epidemiological studies, which include:
- Assessing the impact of substance abuse and chronic pain treatment protocols on patient populations locally, regionally, and nationally
- Understanding current trends to inform pre-market activities and supplement New Drug Applications
- Evaluating effectiveness of abuse deterrent formulations (ADFs) using the mosaic approach
- Tracking or comparing real-world prescription drug abuse trends from different populations of interest
- Understanding behavior associated with prescription drug abuse and misuse, such as route of administration and source of drug acquisition
Customized solutions ensure the most valuable assessments for your product. All Risk Evaluation and Mitigation Strategies (REMS) must include an approach to assessing the effectiveness of their safety measures.
We work with our clients to develop strategies to conduct the most appropriate assessments for both patients and providers. These may include knowledge assessments to evaluate the effectiveness of the REMS activities in informing patients and providers about safe use or conducting drug utilization studies to evaluate appropriate prescribing.
We work with clients to identify the best strategy for data dissemination of key findings to support scientific, regulatory, and business objectives. In partnership with our clients, we design and implement studies, articulate key messages, and develop a strategic plan to reach target audiences.
- More than 80 publications in peer reviewed journals in the past 10 years
- More than 10 books or book chapters published
- Over 100 presentations at professional meetings
- Multiple presentations to the FDA and at Ad Comms