Understand the real-world effects of your product.
When it comes to drug safety and epidemiology, you want real insights, not just information. The best risk management strategies involve continual monitoring of risk-benefit throughout the product lifecycle so that key findings about product safety can be identified and addressed as early as possible.
For safety signals requiring more thorough investigation, Optum™ scientists lead the industry in designing and executing studies in multiple data sources that conform to regulatory standards and enable rigorous assessment of medical products. The results are routinely submitted to regulatory agencies worldwide and published in high-impact peer-reviewed journals. The same scientific expertise has been applied to evaluate the effectiveness of risk-minimization activities.
We help organizations develop and implement a comprehensive risk management approach, utilizing risk management services and tools that include:
- Risk management plan development: Addresses product-specific issues based on pharmacological principles and most current data available
- STORK (Systematic Tracking of Real Kids): Automated pregnancy surveillance system linking mothers and babies to determine maternal exposures, then prospectively relates these exposures to pregnancy outcomes.
- Early access surveillance: Facilitates advanced identification and assessment of targeted safety issues of concern. Captures medical claims in a large insured population in near real-time, helping clients monitor the frequency of targeted safety issues.
Proactive safety, no surprises
Our epidemiology experts work in tandem with clients to develop proactive information plans, then leverage the rich data assets of Optum to create large patient follow-up programs that meet the post-marketing regulatory requirements for safety surveillance and physician compliance to label. Results are then used to guide best practice decisions on marketed and planned products. When ad hoc research is required to answer specific safety questions, we use our existing data to conduct both prospective and retrospective studies, and can also design prospective studies requiring de novo data collection.
Natural history of disease research
Our epidemiology team helps clients avoid confusing drug effects with uncommon but predictable outcomes of disease, and works to pinpoint the diseases in which unmet needs exist. We quantify disease burden and evolution, and profile the patients when a breakthrough drug finds its market.
Clinical epidemiology research
The ability to analyze rich diagnostic, therapeutic and procedural information provides the epidemiology group with a distinctive opportunity to conduct large clinical epidemiology investigations. Whether the goal is to clarify the clinical course of rare diseases, to determine the best therapy in disease subgroups or to delineate risk factors for particular medical conditions, we are poised to make a significant impact in understanding the patients who will ultimately use a product.
Understand the patients who will ultimately use your products.