Post-Marketing (Phase 4) Study Excellence

Post-Marketing (Phase 4) Study Excellence

$4,895.00

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).

  • Keep up with the latest trends in postmarketing studies — including mHealth, real-world data, regulatory concerns — to be innovative, impactful and successful with payers.
  • Consider whether outsourcing particular items is best for your Phase 4 trial team based on how outsourcing affects trial timelines.
  • Determine the best-fit postmarketing alignment across global and regional-level teams.
  • Identify primary objectives behind postmarketing studies to decide what type to conduct.
  • Expertly leverage medical affairs and clinical teams — among other teams — to execute smooth Phase 4 studies.
  • Know when to begin study planning and execution based on product needs, and benchmark your trial timelines against the industry.
  • Right-size postmarketing study budgets and properly allocate these budgets among different study types.
  • Strategize postmarketing studies by comparing data about companies’ number and percentage of studies that are interventional, observational and retrospective.
  • Identify trends in interventional trial design innovations and in observational studies to learn the benefits and risks of different trial designs.
  • Description
  • Additional information

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
Report Features

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.

Reason to Buy

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.

Target Audience

– Medical/scientific affairs director/head/manager
– Medical affairs operations manager
– Operations director
– Clinical research specialist
– Pharmacovigilance specialist
– MSL, MSL manager
– Medical advisor/medical head
– Associate director post-marketing commitments
– Head registries and late phase QA and compliance
– Director medical and scientific communications
– Chief medical officer
– Head of (global) epidemiology
– Clinical development VP
– Technical and quality manager
– Business development
– Medical evidence lead
– Phase 4/IIT director
– Medical director
– Director epidemiology
– Executive director clinical development and product safety
– Director clinical research

Chapter Example

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.