Real-World Science and Late Phase

From full-service real-world late phase programs to standalone services that utilize cost-effective, decentralized strategies to deliver real-world data and observational studies.

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A more efficient, cost-effective path from development to commercialization

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

PREMIER PERSPECTIVE

RWD/RWE as a synthetic control arm

Single-arm trials demonstrate clinical benefit by showing the positive effects of a new therapy or treatment without the need to use a placebo or standard of care as a control. Instead, RWD and RWE comparisons — leveraging a variety of sources — can serve as the comparator.

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How regulators are sizing up evidence today

Adopting decentralized trials and embracing real-world data allow trials to proceed at a time when typical site visits are fraught. Once global regulators are confident the data are still valid and clean, these processes are likely to be more widely implemented.

Real-World Science and Late Phase Experts

Stacy Weil, Ph.D.

Stacy Weil, Ph.D.

Senior Vice President, Clinical Data Operations
Nach Davé, RPh, M.S.

Nach Davé, RPh, M.S.

Vice President, Development Strategy, Premier Research

Related Services

Real-world data and real-world evidence are part of a wide range of service offerings that include biometrics, regulatory consulting, and study design. Follow the links below to learn more about how clients benefit from our specialized expertise.

Biometrics

Regulatory Consulting

Study Design

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