RWE & Post-Approval Studies
Maximizing the impact of your product
From early on in clinical development, we help define strategies and solutions to generate and communicate evidence that demonstrates product value for stakeholders. We’ve established a 30+ year track record of helping sponsors optimize clinical and commercial value.
Proven expertise
Over 30 years of experience in real world evidence (RWE) and post-approval studies.
Global experience
Conducted studies in ~60 countries with a team of over 1,000 RWE experts.
Comprehensive services
From real-world data generation to patient registries and safety surveillance.
Plan your asset’s path to success—from the start
We’ve been performing RWE and Phase IIIB/IV studies for more than 30 years, helping sponsors efficiently generate the data needed to maximize the value of their assets. We help you proactively plan your asset’s path to success from the start by combining our unique perspectives and precision delivery. Our medical affairs and post-marketing teams partner with you to deliver customized solutions that meet your design, peri- and post-approval needs.
Enhancing the benefits of your compound throughout its life cycle
You have needs—we have solutions. Whether you need to explore the design elements of a future clinical program, fulfill a regulatory commitment, anticipate a business opportunity or react to a market event, we are agile enough to respond to your challenges. Fortrea’s portfolio of services provides you with the strategies and solutions you need including:
- RWE strategy, prospective observational studies and retrospective data analyses
- Phase IIIb/Phase IV clinical trials
- Screening and natural history studies
- Post-authorization safety and efficacy studies
- Low-intervention clinical trials
- Observational studies
- Disease/drug registries
- Quality-of-life and patient-reported outcomes
- Health outcomes and RWD for healthcare decision-making
- Health economics assessments and health technology assessment submissions
- Literature review, post-hoc and meta-analysis