Real-World Evidence and Post-Approval Studies

Delivering the full promise of your portfolio and long-term investments.

Fortrea has more than 30 years of worldwide experience in the late-phase industry. We have deep institutional expertise across all therapeutic areas, established investigator relationships and broad real-world insights. This unique combination can help you define strategies and solutions to generate and communicate evidence efficiently, and enable product value demonstration for various stakeholders that:

  • Timely fulfills your post-approval commitments
  • Successfully collects Real-World Evidence (RWE) and extends the value of your compound
  • Strengthens your market position and supports uptake
  • Fills the gap between registration requirements and strategic late-phase study designs
  • Engages with patients in meaningful ways through Patient-Reported Outcomes (PROs)


Maximizing the impact of your product through appropriate design.

Our medical affairs and post-marketing solutions teams partner with you to deliver customized solutions that meet your design, peri- and post-approval needs.

Preparing for and successfully reaching the market is only the beginning of your product’s journey. We combine unique perspectives and precision delivery to help you proactively plan your asset’s path to success from the start.

Translating data to value communications is at the core of what we do.

  • Understanding a compound’s life cycle does not stop with designing the clinical development path to generate evidence. It is ultimately about bringing value to the healthcare community and to patients
  • Converting scientific and therapeutic advances into improved outcomes and communicating their value to payers and physicians is critical so patients can have fast access to your drug and get timely reimbursed for treatment
  • Connecting with key opinion leaders and practitioners across the world to help you create and disseminate your asset’s value through our Investigator Relations Team
  • Recognizing market differences through our market access and commercialization team that has the expertise to build a value story globally and customize it for your local market needs


Enhancing the benefits of your compound throughout its life cycle.

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 understand your challenges. Fortrea’s portfolio of services provides you with a plethora of strategies and solutions to address your needs 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

Deliver consistent results through tailored methodologies.

Our deep strength in Health Economics Outcomes Research, Patient Reported Outcomes (PROs) instrument development, clinical epidemiology, post-marketing commitments, adherence and risk management and our access to real-world and unique data sources allows us to customize solutions that deliver the results you need. Streamlined electronic data capture platforms provide high-quality, cost-effective data.

Develop a post-approval strategy built on strong insights and unique access to patient and investigator databases.

We recognize the challenges you face right up to market access and communicating your product’s value to all involved stakeholders. As your partner, we ensure you have the right strategy to strengthen your market position and maximize your ROI. We offer integrated solutions for evidence generation in a real-world setting, while proactively engaging with our clients to adapt execution strategies to their expectations.

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