Real-World & Late Phase

Nontraditional data points, particularly real-world data (RWD) and real-world evidence (RWE), are becoming increasingly important in the current research climate, and Premier Research offers services to help you develop and execute a real-world data strategy from the very beginning of your development program.

Real-world data development planning, trial design, and regulatory strategy

Global regulators have started to embrace the use of real-world, unstructured data alongside traditional randomized control trial data, a paradigm shift that sets the stage for new, more creative approaches to drug development. This trend is paving the way for a more accelerated pathway to market for sponsors of the most innovative therapies, especially for developers of oncology, rare disease, and emergency use products.

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Premier real-world data and evidence services help you:

• Determine which study designs and study endpoints are most meaningful for patients and caregivers
• Shed light on the existing population size and demographics, which can help better define inclusion and exclusion criteria and reduce screen failures
• Help identify the most appropriate study design and drug development pathway
• Reduce failures through improved protocol design
• Replace elements of the clinical trial process, thereby reducing drug development costs, lowering prices, and increasing incentives for life science research and development investment

Real-world late phase (RWLP) trials

In a multilateral shift, sponsors, payers, regulators, physicians, and patients are increasingly recognizing the value of real-world late phase data to clinical trials. RWLP data is invaluable in bridging the gap from development to commercialization and is a fast-growing segment of the clinical research space; some already view it as critical.

Premier Research’s RWLP trials serve as the critical bridge from clinical effectiveness to a commercially viable brand. They can be used to support:

• The evidence of value needed by payers to authorize and pay for drugs
• The evidence physicians need to prescribe a drug with confidence
• The right information for patients to continue using a drug, so they experience the desired outcomes

Well-designed real-world studies shorten timelines, lower cost, improve the impact of research investments, and get therapies to patients faster. Our offerings range from full-service programs to standalone services that utilize cost-effective, decentralized strategies to deliver real-world data and observational studies.

Benefits of a Real-World Data Strategy

• More accurate patient recruitment
• Faster trial design validation
• Establishing data trends to support endpoints
• Real-time access to data
• Support of fast-track regulatory submissions
• Better decision-making across the health care landscape
• Support 505(b)(2) submissions with RWD
• Link clinical trial data with RWE
• Manage regulatory and non-regulatory grade data in support of product development