1. Market Research
Harnessing the Power of Phase IV Observational Studies

Harnessing the Power of Phase IV Observational Studies

  • October 2015
  • ID: 3362822
  • Format: PDF
  • By Firstword Pharma


Table of Contents

Phase IV studies: Pioneering approaches are re-engineering processes, timelines and costs

Phase IV is in a state of flux. New digital methods are on trial, there’s an explosion of data sources, and more questions about the level of evidence needed are being asked. At the same time, drug companies are trying to control costs. What’s the best way forward?

If you want to design and carry out more effective Phase IV trials studies, you need to find out what lessons have already been learned about lean protocol design, opportunities for savings and considering the patient voice, from companies like Genentech and Sanofi (see the full list). You'll also get fresh insights into how key studies have performed, and clear pointers to what could be improved.

Top Takeaways

Separate standard operating procedures are needed for Phase IV studies
Planning should start earlier for Phase IV studies to improve their effectiveness and business value
Research objectives need to be clear and focussed to avoid waste of resources
New protocols and platforms are beginning to impact on study design, data collection and methodologies
Potential for significant savings exists but these won't be realised until confidence in the methodologies improves
Including the patient's voice is easier – but there are still careful considerations required
Key real-world drug-use learnings can result from new approaches

Key Issues Explored

When should you start considering Phase IV studies in your testing processes?
How patient insights and various customer needs can result in benefits for all stakeholders
Insight into ground-breaking trials and lessons learned so far in 2 key case studies including the Salford Lung Study
The new integrated evidence pathways gaining ground and what their true long-term value is likely to be
The growth and use of databases by researchers
How new partnerships forged by drug companies to progress studies are working in practice
Concerns around quality and reliability of evidence gathered

Who needs this report?

Anyone involved in designing, recruiting, executing or analysing Phase IV studies – to see how they can be improved
Regulatory teams – to gain insights into current and new practices
Executives who want to understand evolution of best practice and explore potential cost savings
Data managers at pharma companies, CROs and associated organisations
Manufacturers and programmers of wearable medical and health devices (such as FitBit) – to understand potential future applications
Patient engagement teams – to understand new ways of involving patients

Who needs this report

Professionals charged with hiring, training, managing or evaluating MSLs and intent on fully leveraging their potential.
Executives who wish to optimise the utility of the MSL function in their organisations.
Managers looking for insights on the future of the MSL role in pharma.
MSLs who want to continue to excel in the field in the years to come.


Charlie Barr, Group Medical Director and Head, Evidence Science and Innovation, Genentech
Dr Nadir Ammour, eClinical Director, Sanofi
Chris Liebman, Vice President, HEOR, Global Market Access, Biogen Idec
Dr Shontelle Dodson, Head of Medical Affairs Excellence, Astellas US
Dr David Leather, Medical Affairs Leader in the Respiratory Franchise, GlaxoSmithKline
Dr Tobias Gantner, Director Health Economics & Market Access, Janssen Germany
Jeff Trotter, co-founder and managing director, Continuum Clinical
Mike Minor, Senior Vice President & Global Head Operations and Strategic Planning, Peri-Approval & Observational Research, ICON
Lynn Okamoto, Executive Vice-President for Late Stage research, InVentiv Health
Kai Langel, Director of patient solutions, e-clinicalhealth

About FirstWord

FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence.

FirstWord Pharma PLUS is a personalised and comprehensive intelligence service delivering up-to-the-minute pharma news, insight, analysis and expert views of importance to your company’s success.
FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors and your markets. Covering biosimilars, market access, medical affairs, sales & marketing, technology and therapy areas, FirstWord Reports provide expert views and intelligence on the challenges facing pharma today.

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 150+ 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:

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

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

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

  • How we can help
    • I am not sure if the report I am interested in will fulfill my needs. Can you help me?
    • Yes, of course. You can call us at +33(0) 4 37 65 17 03 or drop us an email at researchadvisor@reportlinker.com to let us know more about your requirements.
    • We buy reports often - can ReportLinker get me any benefits?
    • Yes. Set up a call with a Senior Research Advisor to learn more - researchadvisor@reportlinker.com or +33(0) 4 37 65 17 03.
    • I have had negative experiences with market research reports before. How can you avoid this from happening again?
    • We advise all clients to read the TOC and Summary and list your questions so that we can get more insight for you before you make any purchase decision. A research advisor will accompany you so that you can compare samples and reports from different sources, and choose the study that is right for you.

  • Report Delivery
    • How and when I will receive my Report?
    • Most reports are delivered right away in a pdf format, while others are accessed via a secure link and access codes. Do note that sometimes reports are sent within a 12 hour period, depending on the time zones. However, you can contact us to escalate this. Should you need a hard copy, you can check if this option is offered for the particular report, and pay the related fees.
  • Payment conditions
    • What payment methods do you accept?
      1. Credit card : VISA, American Express, Mastercard, or
      2. You can download an invoice to pay by wire transfer, check, or via a Purchase Order from your company, or
      3. You can pay via a Check made out in US Dollars, Euros, or British Pounds for the full amount made payable to ReportLinker
    • What are ReportLinker’s Payment Terms?
    • All payments must normally be submitted within 30 days. However, you can let us know if you need extended time.
    • Are Taxes and duties included?
    • All companies based in France must pay a 20% tax per report. The same applies to all individuals based in the EU. All EU companies must supply their VAT number when purchasing to avoid this charge.
    • I’m not satisfied. Can I be refunded?
    • No. Once your order has been processed and the publisher has received a notification to send you the report, we cannot issue any refund or cancel any order. As these are not ‘traditional’ products that can be returned, reports that are dispatched are considered to be ‘consumed’.
  • User license
    • The license that you should acquire depends on the number of persons that need to access the report. This can range from Single User (only one person will have the right to read or access the report), or Department License (up to 5 persons), to Site License (a group of persons based in the same company location), or Corporate License (the entire company personnel based worldwide). However, as publishers have different terms and conditions, we can look into this for you.
Purchase Reports From Reputable Market Research Publishers

Insulin Pens, Syringes, Pumps And Injectors Global Market Opportunities And Strategies To 2030

  • $ 4000
  • March 2020
  • 308 pages

Insulin Pens, Syringes, Pumps And Injectors Global Market Opportunities And Strategies To 2030 provides the strategists, marketers and senior management with the critical information they need to assess ...


Reportlinker.com © Copyright 2020. All rights reserved.

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

Make sure you don’t miss any news and follow us on