Quantify opportunity and justify access

Real World Evidence (RWE) is important for regulatory decision-making and is beginning to touch all areas of the healthcare value chain. Historically, RWE was used for post-market safety monitoring, but now sponsors are beginning to use RWE data to support clinical trial design and observational studies to generate better treatment approaches, while healthcare systems are collecting and using RWE to substantiate coverage decisions.

Real World Data Solutions (RWDS) – A solutions oriented approach to RWE

Drawing on decades of experience, we offer real world data solutions for a variety of client needs across the pharmaceutical development pipeline ranging from RWE inputs into clinical trial design, regulatory strategy, external control arms, global and local market access needs, pricing and reimbursement (P&R) requirements and during market maintenance. Some of the typical research questions addressed are summarized below.

 

  • Quantify Opportunity: Unmet needs, treatment patterns, burden of illness, market sizing
  • Justify Access: Cost minimization, cost offsets, cost effectiveness and budget impact analysis, patient/caregiver/societal perspectives
  • Measure Performance: Drug utilization studies, relative effectiveness, outcomes performance, Post-authorisation efficacy study (PAES)
  • Ensure Safety: Benefit/risk assessment, risk management, signal detection, Post-Authorization Safety Studies (PASS)

Real World Data Strategy

We offer an integrated evidence strategy and planning process for successful market access

  • Evidence gap analysis
  • RWE to support regulatory/market access/P&R strategy
  • Study/Program conceptualization and design
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Real World Data Strategy
Data source assessment, selection and sourcing

Data source assessment, selection and sourcing

 

  • RWD/E landscaping
  • Data source selection
  • Feasibility assessment
  • Data Access
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Study and program planning and implementation

We have rich experience with a variety of data sources and methods. Most clients value the scientific and methodological expertise combined with a solution-oriented project/program structuring approach. Certara has a rich experience of using the following types of data sources/methods

  • Chart reviews and abstractions (single or multi-country)
  • European and U.S. Databases
  • Surveys
    • Qualitative and quantitative surveys
    • Patient-reported outcome measures (PROMs)
    • Discrete choice experiments and preference studies
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Study and program planning and implementation
Data analytics and modeling

Data analytics and modeling

Advanced data or tech-enabled data analytics will ensure faster time to robust outputs and data interpretation

  • Bottom-up approach to examine data: descriptive assessment informs the need for adjusted analyses including regressions and propensity-score matching
  • Exploratory analyses in a dynamic visualization dashboard
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