1. Market Research
  2. > Healthcare
  3. > Health Services Market Trends

Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing

  • June 2013
  • 145 pages
  • Industry Standard Research
Report ID: 2003881

Summary

Table of Contents

ISR believes the rise of risk-based monitoring (RBM) is a result of several forces acting on the pharmaceutical industry. First, electronic data capture (EDC) technology is now the de facto standard for site/ patient data capture. Second, the patent cliff and declining R&D productivity rates have conspired to “force” pharmaceutical companies to look at ways to cut costs, while increasing efficiency. Third, regulators have begun to output guidance documents that center on alternative drug development models and processes (risk-based monitoring, adaptive trials, electronic data as source data), making it less risky for sponsors to employ these methodologies/ strategies.

This report offers the pharmaceutical and biotech industry, and its service providers “peer-based” guidance on the adoption, use, and outsourcing of risk-based monitoring.

What you will learn in this report:

• Sponsors’ interests in and use of RBM studies, why RBM is gaining momentum, what is driving adoption, and a high-level look at sponsors’ expected financial and operational outcomes of RBM studies
• Real-world lessons-learned, including advice for individuals and companies wanting to implement RBM studies
• Study types that are seen as most appropriate for RBM and which departments are involved in the planning of these studies
• On-the-ground suggestions for improving the RBM regulatory and training processes
• Which technologies are most important to running a successful RBM-based trial and which are most difficult to implement
• The percentage of RBM studies outsourced, the preferred types of service providers, and most important service provider attributes impacting selection

How you can use this report:

For sponsors: Use this information to help drive RBM adoption in your organization, avoid pitfalls that might stagger RBM growth, inform your data infrastructure strategies, and benchmark the use of RBM.
For service providers: Better understand the inner working of sponsors as it relates to the adoption of RBM models and craft better messages and service offerings to account for these views.

Valuable for:

Clinical Operations, Medical Directors, R&D Management, Therapeutic Heads, Clinical Service Providers

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 60 Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
  • Single User License — provides access to the report by one individual.
  • Department License — allows you to share the report with up to 5 users
  • Site License — allows the report to be shared amongst all employees in a defined country
  • Corporate License — allows for complete access, globally.

Ahmad helps you find the right report:

Testimonials

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

We were impressed with the support that ReportLinker’s research specialists’ team provided. The report we purchased was useful and provided exactly what we want.

Category Manager at
Ikea

ReportLinker gave access to reliable and useful data while avoiding dispersing resources and spending too much time on unnecessary research.

Executive Director at
PwC Advisory

The customer service was fast, responsive, and 100% professional in all my dealings (...) If we have more research needs, I'll certainly prioritize working with ReportLinker!

Scott Griffith

Vice President Marketing at
Maurice Sporting Goods

The research specialist provided prompt, helpful instructions for accessing ReportLinker's product. He also followed up to make sure everything went smoothly and to ensure an easy transition to the next stage of my research

Jessica P Huffman

Research Associate at
American Transportation Research Institute

Excellent customer service. Very responsive and fast.

Director, Corporate Strategy at
Ingredion

I reached out to ReportLinker for a detailed market study on the Air Treatment industry. The quality of the report, the research specialist’s willingness to solve my queries exceeded my expectations. I would definitely recommend ReportLinker for in-depth industry information.

Mariana Mendoza

Global Platform Senior Manager at
Whirlpool Corporation

Thanks! I like what you've provided and will certainly come back if I need to do further research works.

Bee Hin Png

CEO at
LDR Pte Ltd

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

Purchase Reports From Reputable Market Research Publishers

2017 Analysis of the Global Tumor Marker Testing Market: Emerging Opportunities and Growth Strategies for Instrument and Reagent Suppliers

  • $ 28500
  • Industry report
  • March 2017
  • by Venture Planning Group

Highlights - Identifies and evaluates major business opportunities emerging in the tumor marker market during the next ten years- Examines trends in the U.S., Europe and Japan- Reviews current and emerging ...

Tumor Markers 2021: Reagents and Instrumentation--Supplier Shares and Strategies, Country Segment Forecasts, Emerging Opportunities

  • $ 21100
  • Industry report
  • March 2017
  • by Venture Planning Group

Complete report $34,750.  DataPack (test volumes, sales forecasts, supplier shares) $21,100. Highlights - Identifies and evaluates major business opportunities emerging in the tumor marker market during ...

2017 Competing in the Global Cancer Diagnostics Market

  • $ 21100
  • Industry report
  • March 2017
  • by Venture Planning Group

This new VPGMarketResearch.com comprehensive seven-country study identifies and evaluates major business opportunities emerging in the cancer diagnostics market during the next five years; examines trends ...


ref:plp2013

Reportlinker.com © Copyright 2017. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.