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Informational resources 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 email with a link to download the PDF.

To post your company’s white paper, contact Russ Titsch, Business Development Director at russ.titsch@centerwatch.com or call 703-538-7651.
Centralizing Your Clinical Trials Office

Centralizing Your Clinical Trials Office
Published: by PFS Clinical

Have you ever wondered if moving towards a centralized clinical trials office model is right for your research program? With risk mitigation in mind, this white paper will address the ways in which centralizing your clinical trials office promotes compliance through stronger communication across your research program, resulting in more efficient, streamlined research operations.

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2018 State of Technology in Clinical Research

2018 State of Technology in Clinical Research
Published: by Forte

With this report, discover what over 800 research professionals think about technology's impact on clinical trial operations and learn the necessary steps to see more value from your research systems.

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Recommendations to Consider When Sourcing Human Biospecimens

Recommendations to Consider When Sourcing Human Biospecimens
Published: by BioIVT

Gain insight into ethical considerations in human biospecimen procurement and use for research

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Fastest drug developers and their practices

Fastest drug developers and their practices
Published: by CenterWatch

Drug development is a long and costly process, and companies struggle with efforts to compress cycle times and reduce costs. This paper discusses the rising costs to develop new drugs, rapid development of transformative therapies, the use of new technology and the reorganization of R&D to achieve greater speed and efficiency.

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Utilizing a Protocol Cost Savings Analysis to Reduce Drug Development Costs

Utilizing a Protocol Cost Savings Analysis to Reduce Drug Development Costs
Published: by PharmaSeek

Protocol Cost Savings Analysis (PCSA) is a promising tool that will directly impact pharmaceutical manufacturers’ R & D expenses. This white paper discusses how using a PCSA to align protocol procedures with routine care allows for significant cost savings.

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Ensuring You’re Insured - Unpacking the Insurance Provisions of Clinical Trial Research Contracts

Ensuring You’re Insured - Unpacking the Insurance Provisions of Clinical Trial Research Contracts
Published: by PFS Clinical

Confused about insurance provisions for research contracts? In this article, unpack the meanings behind basic clinical research insurance terms and learn negotiation tips to help you ensure you're insured.

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Too Much of a Good Thing: Clinical Study Sites Struggle to Manage Responses to Ad Campaigns

Too Much of a Good Thing: Clinical Study Sites Struggle to Manage Responses to Ad Campaigns
Published: by WIRB-Copernicus Group

An overwhelming response to a media campaign can paralyze a study site. Many sites are ill-equipped to handle the volume of referrals generated by a successful campaign. Referrals don’t get processed—or are processed incorrectly. Subjects are lost and the trial is delayed. There is a solution: Enrollment assistants.

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Five Essential Considerations for Efficient Site Contracts and Payments

Five Essential Considerations for Efficient Site Contracts and Payments
Published: by Clintrax Global

There are many challenges involved in executing global clinical trial agreements and, in turn, performing investigator payments in clinical research. A number of these challenges can be averted with proper planning and execution in the budget development stage.

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Millennials accelerate seismic shift in clinical operations

Millennials accelerate seismic shift in clinical operations
Published: by CenterWatch

Millennials, the largest age demographic in the U.S., are dramatically reshaping the clinical research industry. This paper discusses the ways this age group is changing the industry as patients, how they are increasingly entering the workforce as researchers, site coordinators and clinicians, and how they are poised to re-shape traditional management roles and carve out new job descriptions for specific data management and technology needs.

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Shifting the Tide of Inefficient Site Contract Negotiations: Turn to an Expert

Shifting the Tide of Inefficient Site Contract Negotiations: Turn to an Expert
Published: by WIRB-Copernicus Group

Contracting may sound unexciting, but it’s just as important as IRB approval, patient enrollment—even the delivery of the medication to the site itself. After all…no contract, no clinical trial.

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Avoid enrollment pitfalls: find your best-fit clinical trial sites

Avoid enrollment pitfalls: find your best-fit clinical trial sites
Published: by WIRB-Copernicus Group

Selecting the right site is the single most crucial decision you’ll make about your next clinical trial. And perhaps the single most important consideration in selecting a site is whether it can make its enrollment. This paper focuses on five broadly applicable characteristics that sponsors and CROs can evaluate to determine the best-fit sites for their studies.

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Solving the problem of clinical research enrollment

Solving the problem of clinical research enrollment
Published: by WIRB-Copernicus Group

A significant percentage of clinical trials today fail to evaluate the endpoints of their studies because of difficulties in enrolling a sufficient number of patients. This article discusses what can be done to enroll more patients in clinical trials, increase the operational efficiency of a clinical trial and decrease the time it takes to reach the clinical endpoint during trials.

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The need for—and barriers to—adopting eSource

The need for—and barriers to—adopting eSource
Published: by CenterWatch

Electronic data collection responsibility borne by investigative sites to support each clinical trial is onerous, the integration of EMR and eClinical data is making slow progress, with little end in sight. This paper discusses the inefficiencies due to the lack of a standard format for collecting and transferring data, factors contributing to a resistance to change and the implementation of the 21st Century Cures Act.

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Envisioning the site of the future

Envisioning the site of the future
Published: by CenterWatch

There are many forces that drive the transformation of the drug development landscape and how the research environment will function in the future. This paper discusses the integration of healthcare data, the power of data and analytics, the rapid move toward more targeted therapies and customized treatments, along with the desire for a lower cost R&D model.

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Six Practices of High Performing Clinical Research Sites

Six Practices of High Performing Clinical Research Sites
Published: by WIRB-Copernicus Group

Clinical research sites have a tough, but critically important, job. This paper focuses on the rigorous and precise work that high-performing clinical research sites do that make sponsors return to them again and again.

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Growing role for AMC clinical trial offices

Growing role for AMC clinical trial offices
Published: by CenterWatch

New funding and expanding service offers show that CTOs are gaining visibility and leverage within AMCs. This paper discusses the significant value CTOs in AMCs offer to industry sponsors, along with challenges ranging from a lack of resources to the implementation of new software.

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Looking Ahead to 2018: Insights into Clinical Research Trends from Our Experts

Looking Ahead to 2018: Insights into Clinical Research Trends from Our Experts
Published: by WIRB-Copernicus Group

In this paper, some of the WIRB-Copernicus Group thought-leaders provide their insights on what they are watching for and what they anticipate in 2018 in clinical trial technology, regulatory changes and scientific developments.

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eTMF adoption and integration accelerating

eTMF adoption and integration accelerating
Published: by CenterWatch

eTMF is being increasingly adopted and integrated with other systems, and is becoming an essential component of clinical trials in the future. This paper discusses cloud-based eTMF, current eTMF usage and adoption, the technology involved and the challenges posed.

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Compensating Participants in Clinical Research: Current thinking

Compensating Participants in Clinical Research: Current thinking
Published: by WIRB-Copernicus Group

Sponsors, researchers and IRBs are often wary about payments in research participation, citing concerns about coercion and undue influence, whether real or perceived, and have avoided payments that are “too high.” But new research brings a new perspective—are payments to participants actually too low? This paper explores this question and whether there should be less concern about restricting compensation for research participants.

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Advancing patient protection through proposed Common Rule changes for informed consent

Advancing patient protection through proposed Common Rule changes for informed consent
Published: by CenterWatch

Research practitioners eagerly anticipated the finalization and publication of the revised U.S. Federal Policy for the Protection of Human Subjects, the Common Rule. This paper discusses the proposed changes, the identification of new elements of informed consent and the effect of the revised requirements on clinical research practice.

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Sites smothered by technology solutions

Sites smothered by technology solutions
Published: by CenterWatch

Technology solutions help sponsors and CROs make better drug development decisions, streamline processes and reduce clinical trial costs. But the majority of investigative sites are inundated with a growing number of technologies that rarely interact with each other. This white paper explores technology usage, challenges and solutions investigative sites are adapting to.

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…But Is It Gene Therapy? Debating a (Controversial) Definition

…But Is It Gene Therapy? Debating a (Controversial) Definition
Published: by WIRB-Copernicus Group

In August, the FDA announced the approval of the first "gene therapy" to receive such a label, tisagenlecleucel (KymriahTM, Novartis Pharmaceuticals) for certain forms of acute lymphoblastic leukemia (ALL). This paper looks at the various definitions of gene therapy used by scientific and regulatory organizations, and why the use of this term generates both confusion and passionate opinion.

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Alphabetical Glossary of Terms: Gene Therapy & Immunotherapy

Alphabetical Glossary of Terms: Gene Therapy & Immunotherapy
Published: by WIRB-Copernicus Group

A glossary that provides clarification of commonly used terms in gene therapy, gene editing, genetic-based precision medicine and immunotherapy. The terms in this glossary are listed alphabetically, with illustrations for key concepts.

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Choosing the Right Solution: Improving the Site Feasibility Process

Choosing the Right Solution: Improving the Site Feasibility Process
Published: by WIRB-Copernicus Group

The process of site feasibility has changed over the years. Sponsors have transitioned to cloud-based site feasibility solutions, yet not all are created equally to handle the complexity of cutting-edge research being conducted. This paper explores the use of a solution specifically designed for site feasibility.

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Gene Therapy and Genomic Editing: Understanding Basic Concepts

Gene Therapy and Genomic Editing: Understanding Basic Concepts
Published: by WIRB-Copernicus Group

Recent advances in recombinant DNA technology—especially CRISPR techniques—have raised public interest in the potential for genome editing. This paper provides a brief background to help better understand the roles of gene therapy and genome editing in clinical trials and pharmaceutical development.

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Innovation in Investigator Site Contracting

Innovation in Investigator Site Contracting
Published: by Clintrax Global

In the perpetual pursuit of a more efficient clinical research process, sponsors and CROs have traditionally focused their resources on the more costly and time-consuming aspects of study start-up—protocol development, regulatory and ethical review and data management and analysis. Bu targeting sponsors and CROs, contract negotiation can be expedited, reducing cycle time and burden on legal infrastructure.

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Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference

Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference
Published: by WIRB-Copernicus Group

This paper explores how sponsors and investigators can design research protocols that clearly address whether clinical intervention is occurring within, or outside of the context of the research, and why this distinction is critical to ensuring regulatory compliance.

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Investigational Drugs Outside of Clinical Trials: Understanding Expanded Access and Right-to-Try

Investigational Drugs Outside of Clinical Trials: Understanding Expanded Access and Right-to-Try
Published: by WIRB-Copernicus Group

Clinical trials can allow access to potentially effective treatment options for patients with a serious disease or condition; however, trials are designed to systematically test investigational therapies. This paper will discuss the complex issues around giving patients access to investigational drugs during the development process.

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Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution

Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution
Published: by ePharmaSolutions

The volume of safety reports being sent to investigative sites is frustrating for investigators. How can we ensure that investigative sites only receive the reports they truly need to review? This question must be answered in order to bring efficiency back to the review process and to ensure that investigators are spending their time where it matters most—with study participants.

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Minimizing Impact of New NIH Recombinant DNA Advisory Committee Review Process on Early Phase Human Gene Therapy Studies

Minimizing Impact of New NIH Recombinant DNA Advisory Committee Review Process on Early Phase Human Gene Therapy Studies
Published: by WIRB-Copernicus Group

The new NIH Guidelines for Research with Recombinant and Synthetic Nucleic Acid Molecules (the NIH Guidelines) detailing revision to the NIH Recombinant DNA Advisory Committee (RAC) process has taken effect. This paper describes the new process and strategies to minimize the impact of the changes on early phase human gene transfer studies.

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Pragmatic Clinical Trials: What You Need to Know

Pragmatic Clinical Trials: What You Need to Know
Published: by WIRB-Copernicus Group

The concept of performing more pragmatic clinical trials is gaining momentum. This document discusses what pragmatic clinical trials are, and how they are designed and intended to answer important questions in healthcare.

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The Revised NIH Guidelines 2016: Assessing the Impact on Human Gene Transfer Clinical Trials

The Revised NIH Guidelines 2016: Assessing the Impact on Human Gene Transfer Clinical Trials
Published: by WIRB-Copernicus Group

The overwhelming majority of human gene transfer (HGT) clinical trials conducted in or from the U.S. are subject to the NIH Guidelines. This paper describes the impact of the revisions to the NIH Guidelines on the rate of RAC review of HGT protocols, the rate of HGT protocol registration and on the roles and responsibilities of local institutional regulatory oversight bodies in the revised review process.

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Impact of ICH E6 (R2) - Data Management Metrics White Paper

Impact of ICH E6 (R2) - Data Management Metrics White Paper
Published: by Metrics Champion Consortium

This paper addresses the revision of the GCP-ICH Eg (R2) and defines the Critical Success Factor and Key Performance Questions (KPQs) that are needed to answer questions due to the revision. The MCC work group has also developed two new metrics that help to answer KPQs.

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MCC Vendor Oversight Metric Updates ICH-E6(R2) Review Progress Report

MCC Vendor Oversight Metric Updates ICH-E6(R2) Review Progress Report
Published: by Metrics Champion Consortium

This paper looks at developing current metrics that focuses on individual trials and developing them specifically for vendor oversight with the revision to GCP-ICH E6 (R2). The work group realized the growing integration among clinical trial systems meant there were greater opportunities to implement metrics that use data from different systems to report new metrics that give greater insights.

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MCC Study Quality Trailblazer Team

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

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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Mobile health picks up momentum

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

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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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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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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