Managing Real World Data

Maximum Purchase:
1 unit
Publication date:
October 2012
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This definitive report on RWD helps pharma companies navigate the complexities of developing, accessing, and using real-world data sources, and provides guidance on developing a successful RWD strategy.

Key RWD concepts and terminology are clearly defined, and detailed descriptions of RWD trends give you a clear picture of RWD today, and an insightful look at what to expect tomorrow.

Companies who are getting ready to think strategically about RWD will find step-by-step guidance on gaining internal strategic alignment, choosing an operating model, and gaining a seat at the policy-making table. This invaluable resource also examines the pros and cons, and other critical considerations, of many strategies, including buying vs. partnering.

Pharma companies must evolve RWD strategies sooner rather than later. Managing Real-World Data provides the know-how you need to succeed.

Key features of Managing Real-World Data include:

  • Overview of how Big Data is revolutionising healthcare
  • Clarification of terminology and concepts
  • Current look at how pharma companies are using RWD
  • Review of the main sources of RWD
  • Guide to observational research methodologies
  • Organisational considerations to developing an RWD strategy
  • Benefits and risks of in-house vs. external sources
  • RWD’s important role in product life cycle management

Key Benefits

The strong shared interest in RWD is driving the centralisation of disparate data sources, and leading to revolutionary new kinds of healthcare partnerships. In this rapidly changing environment, pharma companies who move quickly to develop a clear RWD strategy will be at a considerable competitive advantage. This report will help you to:

  • Eliminate confusion over what RWD is and does
  • Prepare your organisation for the challenges of implementing an integrated RWD strategy
  • Understand where to obtain different types of RWD
  • Be aware of the strengths and weaknesses of primary data sources
  • Gain an understanding of different study types and designs that can be used to fill data gaps
  • Know how RWD helps fulfill regulators’ increasing demands for safety data in the non-clinical-trial setting
  • Learn about ways in which RWD can be used, such as interpreting epidemiology trends
  • Discover ideas for possible partnerships, and know how to bring them to fruition

Managing Real-World Data
answers key questions including:
  • What is RWD and why is it important?
  • How are companies using RWD?
  • How are observational research methodologies changing?
  • How can RWD assist in market access and reimbursement?
  • How should we structure our organisation to facilitate RWD collection?
  • Should we build or buy?
  • What are the advantages of working with external parties to obtain data?
  • How can RWD support a product’s entire lifecycle?

Selected Quotes

“If you are in pain that is not something your doctor is necessarily best placed to assess for you. These are subjective experiences. … PROs [are] valuable because healthcare is about more than just hard outcomes.” Alex Thompson, head of epidemiology, PROs and healthcare data strategy, Roche UK

“War is too strong a word but there is fierce competition in how companies are using RWD to demonstrate the real impact of their products.” Jamie Cattell, principal and leader, McKinsey &s Co’s Global Healthcare Technology practice

“The beauty of RWD is that you don’t just have to study one product or one step in a disease pathway, but you can look at multiple aspects.”  Rick Lones, executive medical director, Bristol-Myers Squibb UK

“We want to develop standards for partnership selection and assemble the right internal people with the key capabilities to ensure a systematic approach. We are considering a ‘string of pearls’ approach because different payers will have different competencies.” Norman Rosenthal, head of scientific affairs, Johnson & Johnson North America