Post-Marketing (Phase 4) Study Excellence


This report focuses on Phase 4 studies in terms of strategy, resources, timelines and trends. Use data from across the industry to determine best-fit postmarketing alignment across global and regional-level teams, and expertly leverage medical affairs and clinical groups — among other teams — to execute smooth postmarketing studies. Data include trial timelines and schedules for study planning and execution, budget allocations, and breakdowns of major study types (observational studies, interventional studies and retrospective studies).

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Report Details

This report focuses on postmarketing study strategy, resources, timelines and trends.  It examines postmarketing studies by comparing data about companies’ number and percentage of studies that are interventional, observational and retrospective.  It will help to identify trends in interventional trial design innovations and in observational studies to learn the benefits and risks of different trial designs and much more!

  • 6 chapters + an Executive Summary
  • 115 graphics
  • 5 appendix tables

Data have been split by team region:

  • Global
  • US
  • Country-Level

Data have also been split by company size:

  • Top 10
  • Top 50
  • Small
  • Device

Study case studies:

  • Interventional
  • Observational
  • Retrospective

Top Reasons to Buy This Phase 4 Studies Benchmarking Report

Benchmark your post-marketing and Phase 4 trial timelines: One critical measure of post-marketing study productivity is the trial timeline. Time is money, and unreasonably long timelines both hurt the company financially and could hurt the studied product’s market position should competitors collect late-stage data faster. The study includes detailed metrics to benchmark your study timelines against the typical duration for interventional, observational and retrospective trials. 

Compare relative study costs to determine future spending: Although Phase 4 and post-marketing study cost is not the primary consideration for pursuing a specific trial, it is an important factor. The report’s data show percentage of annual costs allocated to different post-marketing study types. It also compares study costs for interventional, observational and retrospective among Top 10, Top 50 and small pharmaceutical companies. The data are also broken down to show costs for global, US, European and Latin American regions.

Leverage medical affairs’ expertise to guide post-marketing study development:
This report provides an in-depth discussion regarding companies’ general post-marketing study structures, including the functions involved and the responsibilities they undertake. The study includes a particular focus on medical affairs teams, who often provide additional guidance on Phase 4 activities. In fact, among all companies surveyed, medical affairs functions overwhelmingly handle the planning aspect of post-marketing research. The study found that surveyed life science teams with 78% of dedicated post-marketing study groups are aligned under medical affairs.

Outsource post-marketing study activities to decrease average duration from protocol design to training: A common point of discussion is whether the sponsor company should outsource its Phase 4 and post-marketing studies. After all, outsourcing certain activities can provide efficiency and speed during Phase 4. This report breaks down the most commonly outsourced post-marketing study activities, as well as those activities which make more sense to retain in-house.


Excerpt from Postmarketing Study Excellence

Postmarketing studies are undergoing a revolution. No longer seen as optional, late stage studies are conducted to investigate product effectiveness, health economic outcomes, product utilization and other key data not readily collected in Phase 3 trials. Phase 4 studies are necessary for some products to maintain market authorization and are crucial for earning product reimbursement and market share.

Late-stage study teams are innovating trial designs beyond traditional randomized controlled trials (RCTs) to examine specific endpoints and to collect real-world data. These study designs include newer interventional studies such as pragmatic RCTs as well as advances in observational and retrospective studies. This report analyzes the percentage of postmarketing studies that adhere to different interventional and observational study designs and compares benchmarks for these designs.


Post-Marketing (Phase 4) Study Participation List