Late Phase Research
OptumInsight provides specialized, Late Phase CRO services and expert perspective on global market requirements to help companies make strategic decisions about their products. Our dedicated late phase CRO services include "full service" support for peri-approval and post-marketing observational studies, Pragmatic Trials, Post-Authorization Safety Studies (PASS) and Post-Authorization Efficacy Studies (PAES), and interventional phase IV studies to evaluate comparative effectiveness and safety in a real-world setting. These solutions enable life science companies to improve market position, fulfill regulatory requirements, pricing leverage and mitigate business loss post expiry.
Efficient execution of late phase research requires a multifaceted approach that involves demographic data mining, scientific study design and analysis, therapeutic expertise, epidemiology and pharmacovigilance expertise, risk management, global regulatory affairs expertise, and a deep knowledge of real-world research. Our focus on specialized expertise allows us to integrate these areas for a competitive advantage, which culminates in helping sponsors demonstrate the actual value of their products in the market.
- Customized Study Design. Our team operates as an extension of your team to understand your study objectives and data requirements. We can work together with you to tailor a study design that answers your particular research question and addresses the issues.
- Dedicated Late Phase Expertise. We understand the unique challenges associated with these types of studies. Because we only handle late phase trials and not Phase I-III, you’ll realize the advantage of working with true specialists in this area.
- Innovative Technologies. Our Smart Measurement System (SMS) for Late Phase is an end-to-end clinical trial management solution that simplifies and streamlines processes, provides robust reporting/analysis capabilities, and thus helps drive accelerated patient enrollment and lowered costs.
- Access to Unique Data Sets. Through our affiliation with a large well-known insurer, we have access to millions of clinical records—and our people have the knowledge to then leverage those to the benefit of your clinical trial.
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PASS and PAES trials can be resource-intensive and often involve a large number of patients, sites, and countries; follow-up periods of 10 years or more are not unusual. OptumInsight is well-versed in successfully conducting PASS/PAES trials as part of our overall late phase service offering.
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Pragmatic trials combine “interventional” and “observational” elements in the same study. To date, a limited number of these types of studies have been sponsored by pharmaceutical companies, but there is growing interest in their use for demonstrating real-world effectiveness.
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