Life Sciences

Accelerate decisions and mature your research across the product life cycle with one of the largest global sources for novel real world evidence that’s imaging focused.

Real World Evidence (RWE) as a Global Drug Development Mandate

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The shift from Phase III approval to reimbursement approval has created the need for an integrated approach to establishing evidence, including cost and clinical differentiators, early in the development cycle. New datasets needed to accomplish this include imaging and pathology, which are larger, more complex and more diverse than clinical trial data. Read Deloitte’s annual RWE benchmarking survey.

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Medical imaging and pathology data assets are emerging as a powerful and broad-based capability to mature and inform increasingly complex value arguments in drug development, specifically differentiating life sciences companies focused on oncology, cardiology and neurology pipelines.

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What first began as a research need to identify novel imaging biomarkers, there is now a growing RWE imperative to extend imaging data alongside claims, EHR, genomics, patient registries, and other evolving datasets. This explosion of data is now creating the challenge of managing an ever-expanding network of evidence. This shift in both the availability of, and reliance on, real world data for improving the quality of evidence has become a mandate from the FDA in the U.S., as well as from the MHRA and the EMA in Europe.

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This rapidly growing need for broader information on real world effectiveness and safety is driven by regulators, public and private payers, and prescribers. These stakeholders seek to better understand the impact of a new product in a real world setting, which ultimately affects utilization and reimbursement. The result is that RWE is now included earlier in the research and development phase, which warrants the need for deeper secondary data assets such as imaging and pathology results that influence therapy choices.

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Redefining Transformative Collaboration to Serve an Evolving and Complex Need

RWE, when used to its full potential, is not a discreet project with a finite set of licensed data assets to answer questions in a controlled time period. The power of RWE is that it is a ‘living’ dataset you add to over time, which allows you to answer questions as they arise. With a global provider network that has a registry of patients, the ability to move from retrospective to prospective data assets that are operationalized with a consented cohort across facilities becomes realistic. This is similar to a cellular network subscriber where the subscriber controls data access instead of the app developer.

The Life Image network brings efficiencies to RWE and clinical research projects requiring consortia where ‘building’ a set of trial site partners can be executed in real time. Learn more. 

Life Image’s team offers leadership in design and execution of real world data access and governance strategy across the lifecycle by:

  • Helping you build a fit-for-purpose RWE network specific for your pipeline in the U.S. or globally.
  • Solving the data interoperability problem of marrying data assets from multiple vendors. 
  • Solving the prospective real world data accessibility issue for consented patients across thousands of hospitals.
  • Providing patient recruitment specific to a therapeutic area and an engagement framework with white label PHR already integrated with health systems. 
  • Building and managing disease, product or patient registries.
  • Bringing one of the top FDA-approved diagnostic imaging viewers, which can be deployed globally within days/weeks, to help researchers and providers collaborate in real-time.
  • Leveraging our partnership ecosystem with leading vendors in a variety of sectors. They include targeted diagnostics and AI companies; payers such as Blues Plans; and tech companies such as Google. This capability allows us to bring a unique perspective to drive commercial precision.

What is Real World Evidence?

Real world evidence refers to evidence derived from “real world data,” or observational data that is collected during typical use of a product (generally, after FDA approval).Real world evidence stands in direct contrast to pre-clinical research and clinical trials, which are conducted in highly-controlled environments with rigorously selected patient populations identified by RCT protocols (Randomized Clinical Trials)

However, the percentage of approved drugs actually representing real-world patients in the market today is less than 20.

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