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Informational resources created to give industry professionals a more detailed look at specific areas of the clinical research industry.

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The Clinical Trials Unit NEW!

The Clinical Trials Unit: Defining, Staff Assessment and Scheduling Restructuring for Operational Efficiency
Published: by FTI Consulting

In the complex landscape of clinical research site management, provider organizations should consider opportunities for operational efficiency.

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Electronic Clinical Outcome Assessments (eCOA) - An Introductory Guide NEW!

Electronic Clinical Outcome Assessments (eCOA) - An Introductory Guide
Published: by CRF Health

What is eCOA and why are regulators increasingly pushing for its adoption? Learn the basics in our new guide.

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Study grants market breaks $13 billion NEW!

Study grants market breaks $13 billion
Published: by CenterWatch

CenterWatch analysis of the global clinical trial grants market, a critical measure of the overall health of the enterprise, revealed a mixed message about the volume of clinical activity. The white paper delves into the reasons behind why the volume of clinical activity is rising while growth in grant spending has slowed significantly:

  • Industry-sponsored clinical trial activity has increased compared to a decade ago, yet growth in grant spending to investigative sites from both the government and industry has continued to slow significantly.
  • Total spending on global clinical trial grants to sites reached $13.5 billion in 2014, growing about 2% a year since 2008.
  • Growth in government grant spending, in particular, declined -1.8% each year since 2008, while growth in industry spending during the past six years slowed to one-third of its previous level.
  • The deceleration of growth in grant spending raises concerns for sites, which already have seen profit margins erode over the past six years and feel pressure from sponsors and CROs to perform at higher levels for the same grant dollars.
  • Growth in grant spending also has been affected by the increasing complexity of clinical trial protocols.

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CROs Driving Changes in Patient Recruitment NEW!

CROs Driving Changes in Patient Recruitment
Published: by CenterWatch

Major CROs now consider patient recruitment services, once used primarily to rescue under-enrolling studies, as a core activity in study planning. Providing strategies for patient recruitment has become critical to staying competitive in the marketplace.

The white paper delves into exactly how, and to what extent, large CROs and stand-alone patient recruitment companies are jockeying for exposure:

  • Large CROs have moved into the space as the entire industry redefines patient recruitment practice with new technologies and strategies.
  • Electronic medical records and other patient data sources have allowed more effective and cost-efficient targeting of patients.
  • The internet and mobile devices have opened more channels for raising awareness about clinical trials and communicating with patients.
  • Stand-alone patient recruitment companies are stepping up tactics and developing innovative ways to reach potential patients in order to compete in the changing landscape.
  • The landscape will continue to evolve because patient recruitment remains one of the biggest challenges in clinical research.

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Private Equity Driving Dynamic CRO Growth

Private Equity Driving Dynamic CRO Growth
Published: by CenterWatch

Private equity (PE), which has been very active in the CRO space over the past five years, is reshaping the CRO landscape—giving the industry financial stability it might not otherwise have and providing the capital for CROs to expand, both organically and inorganically, to offer a broader range of services and greater efficiency to support R&D operations. The white paper delves into exactly how, and to what extent, PE is driving CRO growth.

  • PE has changed the look of the industry over the past 10 years.
  • It has added a level of credibility to the space by being willing to buy an asset like a CRO.
  • PE gives the ability to develop long-term strategies that better integrate drug development services and improve R&D innovations.

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Complion White Paper

Regulatory Compliance: An Increasing Burden on Sites
Published: by Complion

While there is wide agreement that the regulatory compliance burden for sites is high, few initiatives have been launched in the industry and little to no data exists to quantify this regulatory compliance burden on sites. A new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.

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Cloud Computing Expanding Into All Areas of Clinical Trial Conduct

Cloud Computing Expanding Into All Areas of Clinical Trial Conduct
Published: by CenterWatch

The potential benefits of cloud computing in clinical trials—lower R&D costs, ease of use, rapid scalability, flexibility, availability--are beginning to outweigh the complexities and challenges of finding the right vendors. CenterWatch takes a look at how this new trend is shaping the industry including a case study of a company's recent transition.

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Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional

Taking the Risk-Based Monitoring Plunge: Who’s Doing It, How They’re Approaching It, and the Metrics They’re Using to Manage It
Published: by Metrics Champion Consortium

This new report gives current RBM users the ability to compare the RBM methods they currently employ to those utilized by a large sample of biopharmaceutical, CRO and academic research organizations. It also gives new RBM users information that will allow them to accelerate and focus their implementation. The report includes over 40 figures, tables and graphs covering a wide range of areas.

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Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional

Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional
Published: by Various Authors

For physician investigators, CRCs and CRAs, there are certification programs which are highly regarded, but there are no formal regulations which define the educational or experiential requirements to conduct clinical research. This paper will discuss the newly formed Joint Task Force for Clinical Trial Competency (JTF) and its work towards creating a single, high-level set of standards which could serve as a framework for defining professional competency throughout the clinical research enterprise.

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MSLs Play a Growing Role in Patient Care and Clinical Research

MSLs Play a Growing Role in Patient Care and Clinical Research
Published: by CenterWatch

Originally hired by sponsors to perform outreach with payers and providers while their drugs were awaiting FDA approval, medical science liaisons have seen their role evolve dramatically over time into more of a global pharmacological resource who can present data in a fair and clear way for the improvement and benefit of patients and the overall public health sector.

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The Process of Informed Consent

The Process of Informed Consent
Published: by ACRP

In this ACRP guidance document the Association describes how to best structure the informed consent process in accordance with best practices.

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The Pulse on Study Conduct—Best Practices and Critical Strategies to Ensure Site Success

The Pulse on Study Conduct—Best Practices and Critical Strategies to Ensure Site Success
Published: by CenterWatch

Industry expert Elizabeth Blair Weeks-Rowe offers solutions to achieve study conduct success from ensuring clean data to preparing for a co-monitoring visit.

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The Pulse on Recruitment--Exploring the Use of Social Media and Online Tactics in Patient Recruitment

The Pulse on Recruitment—Exploring the Use of Social Media and Online Tactics in Patient Recruitment
Published: by CenterWatch

Industry experts offer insight into the challenges and potential benefits of social media and online patient recruitment.

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Site Landscape Shrinking, Losing Most Active PIs

Site Landscape Shrinking, Losing Most Active PIs
Published: by CenterWatch

High turnover and an influx of novice investigators have been the key drivers plaguing the site workforce recently. CenterWatch analyzes the reasons for the shift and the affects it's having on the industry.

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Issues in Research Management: Protocol Challenges in the Era of Complexity

Issues in Research Management: Protocol Challenges in the Era of Complexity
Published: by CenterWatch

Learn about site/sponsor responsibilities and effective strategies to manage protocol amendments.

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The Pulse on Recruitment—Recruiting patients on TV and radio

The Pulse on Recruitment—Recruiting patients on TV and radio
Published: by CenterWatch

Learn effective tips and strategies to draw the most response out of your television and radio recruitment campaigns.

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Top pharmaceutical companies balance profits with pipelines

Top Pharmaceutical Companies Balance Profits With Pipelines
Published: by CenterWatch

Learn how some of the top pharma companies are keeping the discovery pipeline flowing while balancing their R&D investment with profits earned.

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Another Wave of U.S. Site Acquisition Imminent

Another Wave of U.S. Site Acquisition Imminent
Published: by CenterWatch

SMOs have faded steadily in the U.S. since this trend piqued in the late 90s, yet they continue to flourish worldwide. CenterWatch explores whether or not there's still a U.S. market for these companies.

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Pessimism and Instability Defining the Clinical Research Workforce

Pessimism and Instability Defining the Clinical Research Workforce
Published: by CenterWatch

Learn more about the current state of the clinical research workforce and how a perceived lack of advancement is spurring a more transient industry according to a recent CenterWatch survey.

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Pressure Mounts for Patient Access to Investigational Drugs

Pressure Mounts for Patient Access to Investigational Drugs
Published: by CenterWatch

Read more about how pharmaceutical companies are finding themselves under increasing pressure to allow use of their investigational drugs before they are approved by the FDA and the ensuing debate.

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How Advocacy Groups Are Using the Internet to Target Patients for Disease-specific Recruitment

How Advocacy Groups Are Using the Internet to Target Patients for Disease-specific Recruitment
Published: by CenterWatch

Learn how these groups have taken matters into their own hands by putting the patient in the driver’s seat to help bolster recruitment.

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Spike in Warning Letters Sends Tremors Through Industry

Spike in Warning Letters Sends Tremors Through Industry
Published: by CenterWatch

Find out how and why regulatory agencies have stepped up enforcement efforts and what this means for sponsors, CROs and sites.

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The Pulse on Recruitment

The Pulse on Recruitment
Published: by CenterWatch

Get effective strategies and real-life tips for successful patient recruitment, including how to: recruit during the "slow" season and choose the best pediatric recruitment method.

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Sites Cope with Rising Protocol Complexity

Sites Cope with Rising Protocol Complexity
Published: by CenterWatch

Investigative sites are feeling the burden and cost of complex protocols. Find out how sites and sponsors are tackling this growing problem.

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Moving Toward a Patient-Centered Clinical Trial Model

Moving Toward a Patient-Centered Clinical Trial Model
Published: by CenterWatch

Clinical research is shifting toward greater patient engagement. Learn more about this new trend and its impact on the industry.

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Leveraging Online Resources to Increase Patient Recruitment Rates

Leveraging Online Resources to Increase Patient Recruitment Rates
Published: by CenterWatch

More patients are turning to the Internet for health information than ever before. Learn how to access this critical population.

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Sizing Up the Clinical Research Market

Sizing Up the Clinical Research Market
Published: by CenterWatch

Get a closer look at spending in the clinical research and clinical trial grants markets, which have increased 8% and nearly 10% respectively since 2000.

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