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White Papers

These informational resources were created to give industry professionals a more detailed look at specific areas of the clinical research industry. To download a white paper, click on the appropriate button and follow the registration instructions on that page. Once your information is received, we will send you an e-mail with a link to download the PDF.

To post your company's white paper, contact Melissa Nazzaro, (978) 839-3903.

Fisher Clinical White PaperNEW!

Real-World Insights from the Trenches: Results of a 2013 Worldwide Survey About the Impact of Clinical Supplies on Investigator Sites
Published: by Fisher Clinical Services

Real-World Insights from the Trenches presents the most impactful clinical supply issues facing investigator sites identified by a a global site survey, and proposed solutions to benefit clinical research execution.

Learn more »

The Synergy Orange PaperNEW!

The Synergy Orange Paper
Published: by Synergy Research Group

The Synergy Research Group Orange Paper is issued quarterly. The report looks at the state of clinical trials in Russia and is comprised of data from the country’s Ministry of Health and other sources.

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The outsourcing playbook: How to make regulatory outsourcing effective for the pharmaceutical, biotechnology, and medical device industriesNEW!

The outsourcing playbook: How to make regulatory outsourcing effective for the pharmaceutical, biotechnology, and medical device industries
Published: by Cardinal Health Regulatory Sciences

Outsourcing can help companies accelerate the regulatory approval process, if both the development company and the regulatory consultants communicate well, and set clear expectations.

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Cloud Computing Expanding Into All Areas of Clinical Trial ConductNEW!

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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