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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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Steps to Paperless Research Sites NEW!

Steps to Paperless Research Sites
Published: by Compliion

Research sites are adopting technology solutions for efficiency and enhanced compliance. Retaining paper versions of the Essential Documents is an obstacle to progress. Gain key insight and expertise on using technology to tame the paper beast that threatens efficiency and productivity at clinical research sites.

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MCC Study Quality Trailblazer Team NEW!

MCC Study Quality Trailblazer Team
Published: by Metrics Champion Consortium

Despite the advancements that technology has provided to clinical research over the past 20 years, the pharmaceutical industry is taking longer and spending more money to complete projects, due to preventable issues. Investing time and resources up front can yield higher quality clinical study performance at a lower cost than fixing quality issues during the study.

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Improving Inspection Readiness-Trial Master File Metrics White Paper NEW!

Improving Inspection Readiness-Trial Master File Metrics White Paper
Published: by Metrics Champion Consortium

The Metrics Champion Consortium’s Trial Master File (TMF) Toolkit helps organizations update their TMF filing and oversight approaches to align with regularity expectations. The Metric Toolkit includes a set of core metrics and supporting tools that help manage and improve TMF inspection readiness and reinforce the importance of establishing expectations, measuring actual performance, and fixing problems that arise.

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Single IRB Review for Multicenter Research: A Guide for Institutions NEW!

Single IRB Review for Multicenter Research: A Guide for Institutions
Published: by Schulman IRB

In this guide, we discuss the various new federal requirements for single IRB (sIRB) review and issues for institutions to consider as they work to comply with these mandates.

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Mobile health picks up momentum NEW!

Mobile health picks up momentum
Published: by CenterWatch

Mobile health apps have evolved to fill a gap in healthcare delivery, cut costs and increase access to both care and trials. This white paper explores how mHealth brings quality healthcare and health-related information to the public, connects health workers to continued medical education and improves disease diagnosis and tracking.

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Lack of clinical data overshadows opioid prescribing guidelines NEW!

Lack of clinical data overshadows opioid prescribing guidelines
Published: by CenterWatch

Opioid addiction has become a health crisis. This white paper explores the definition of chronic pain, the evaluation of clinical trials research on opioids for chronic pain, key components of the CDC guidelines for prescribing opioids and the harmful effects of long-term opioid use.

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Is your CTMS working for you?

Is your CTMS working for you?
Published: by Veeva Systems

Discover how a cloud-based clinical trial management system (CTMS) brings together documents and data to better support today's complex clinical trials, where legacy CTMS applications fall short.

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eConsent: How to Improve Efficiency, Compliance, and Engagement

eConsent: How to Improve Efficiency, Compliance, and Engagement
Published: by Quorum Review IRB

Discover how the right eConsent tool will pay dividends by delivering real-world efficiency and improved compliance. Plus, get tips for choosing an eConsent vendor and successfully transitioning away from paper.

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CROs begin consolidating site landscape

CROs begin consolidating site landscape
Published: by CenterWatch

Major trends in drug development will reshape the global investigative site landscape. This white paper explores the trends and transformation in the investigative site landscape, drug development pipeline, patient centricity initiatives, strategic healthcare partnerships and the evolution of the CRO.

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FDA gives guidance to sponsor-investigators

FDA gives guidance to sponsor-investigators
Published: by CenterWatch

In May 2015, the FDA released a draft guidance designed to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This white paper defines sponsor-investigator-initiated trials, explains the rationale for increasing numbers of sponsor-investigator-initiated trials, describes the process for sponsor-investigators to submit an IND and discusses specific items a sponsor-investigator must include in an IND.

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FDA IRB inspections: What, why and how

FDA IRB inspections: What, why and how
Published: by CenterWatch

Professionals enter the clinical trial enterprise every day who may be unfamiliar with the FDA regulations and inspections of clinical trial-related activities. This white paper serves as an introduction to colleagues who are new to the industry and as a refresher for the more experienced professional, but may have never undergone an FDA inspection. This paper is a good resource and an informative guide for what to expect during an FDA IRB inspection.

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A Paradigm Shift in Patient Recruitment for Clinical Trials

A Paradigm Shift in Patient Recruitment for Clinical Trials
Published: by Clinithink

This White Paper describes how Investigative Sites can update their recruitment strategies to automate and accelerate patient pre-screening.

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Right to Try laws challenge clinical trial process

Right to Try laws challenge clinical trial process
Published: by CenterWatch

Right to Try laws have passed in 32 states. The laws grant patients access to investigational drugs if they have a terminal illness, they’ve considered other options and their doctor will give them a prescription for it. Biopharmaceutical companies can choose to sell the drugs to patients or they can offer the drug for free. The laws purport to make the process faster and easier on patients than the FDA expanded access program; however, the Pharmaceutical Research and Manufacturers of America (PhRMA) would rather see patients gain access to investigational drugs under the oversight of the FDA and IRBs.

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Maximize ROI Post-Approval White Paper

Maximize ROI Post-Approval White Paper
Published: by CenterWatch

Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!

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Gamification moving from early science to patient use

Gamification moving from early science to patient use
Published: by CenterWatch

The concept of gamification is helping to solve complex scientific problems while offering patients incentives to comply with their medical regimens through mobile gaming systems that reward adherence, help diagnose illnesses, explain clinical trials and recruit patients. Researchers hope that these kinds of games can train the brain to improve being mindful, aware and alert. Developers would like to make a positive and rewarding experience through good thought patterns and sharp cognitive functions.

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Clinical Trial Knowledge Platform: The Road To Compliance

Clinical Trial Knowledge Platform: The Road To Compliance
Published: by MyClin

This paper describes how myClin's Clinical Trial Knowledge Platform allows for a more auto-documented, data-driven clinical trial oversight, while transforming how study teams collaborate.

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Early Inroads for Wearable Devices in Clinical Trials

Early Inroads for Wearable Devices in Clinical Trials
Published: by CenterWatch

The growth of commercially available wearable devices capable of gathering health information doesn’t seem to be slowing any time soon. These devices hold promise for collecting, transmitting and integrating objective experiential data in real time and in aiding the analysis of a much higher volume of data from a significantly larger number of patients. The prospect of a potentially large market for new devices that can shorten clinical trial cycle times and engage larger numbers of patients is compelling.

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The Clinical Trials Unit: Defining, Staff Assessment and Scheduling Restructuring for Operational Efficiency

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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Study grants market breaks $13 billion

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.

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CROs Driving Changes in Patient Recruitment

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.

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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.

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Regulatory Compliance: An Increasing Burden on Sites

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

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

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 Cara Danchak and Bonnie A. Brescia 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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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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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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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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