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White Papers

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 (617) 948-5114.
Understanding the Humans of the TMF: Evaluating TMF stakeholder attitudes to achieve inspection readiness NEW!

Understanding the Humans of the TMF: Evaluating TMF stakeholder attitudes to achieve inspection readiness
Published: by LMK Clinical Research Consulting

Any solution to the problem of TMF inspection readiness must consider more than just the hardware and software of the eTMF, but must also consider how electronic tools augment the human roles, processes, and relationships that author the narrative within each TMF. This whitepaper, utilizing original survey data, provides insight into the needs and perspectives of TMF stakeholders by examining correlations between TMF stakeholder attitudes and differences in attitudes between TMF stakeholder groups.

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Capturing the Value of Clinical Trial Intelligence NEW!

Capturing the Value of Clinical Trial Intelligence
Published: by Comprehend

More than 86% of clinical trials never get approved, but better data collection, analytics, and management could cut that percentage in half. Using data science, you can unify your data, update it in real time, and automate collaboration for faster issue resolution. Learn how executives, clinical operations teams, medical review teams, and data management teams save time and money, and reduce risk, through timely and accurate clinical intelligence.

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Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk

Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk
Published: by WIRB-Copernicus Group

Automation has helped resolve some of the challenges, but it has created just as many. The system needs a complete overhaul. It can be done, but it requires the willing to invest in change.

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Virtual Clinical Trials: Best Practices in Moving Toward a Patient-Centric Research Model

Virtual Clinical Trials: Best Practices in Moving Toward a Patient-Centric Research Model
Published: by WIRB-Copernicus Group

This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.

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The Most Important Voice Is Missing: The Case For Including Patient Insights In Protocol Design

The Most Important Voice Is Missing: The Case For Including Patient Insights In Protocol Design
Published: by WIRB-Copernicus Group

Patient voice isn’t an accessory; it’s foundational. Patients are key to clinical trials, and relegating them to mere “subjects” diminishes their value. Including the patient voice in study design and development can make an enormous difference in recruitment, enrollment, and retention.

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Recommendations for Study Sponsors on Anticipated Required Changes for Informed Consent Documents

Recommendations for Study Sponsors on Anticipated Required Changes for Informed Consent Documents
Published: by WIRB-Copernicus Group

This document is intended to summarize the regulatory changes that apply to informed consent documents, and to provide extra-regulatory and informal guidance where helpful, to help sponsors update informed consent document templates to be compliant with the new regulations.

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Looking Ahead to 2019: Insights into Clinical Research Trends from Our Experts

Looking Ahead to 2019: Insights into Clinical Research Trends from Our Experts
Published: by WIRB-Copernicus Group

Seventeen senior WCG thought leaders share what they anticipate for the clinical research industry in 2019, and what everyone should be prepared for as we approach another year of change.

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Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials

Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials
Published: by WIRB-Copernicus Group

Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question. Read this white paper to learn the impact that participant payments may play on clinical trial recruitment.

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Precision Medicine: A Glossary of Terms

Precision Medicine: A Glossary of Terms
Published: by WIRB-Copernicus Group

The purpose of this glossary is to provide clarification of commonly used terms in the discussion of genetics, genetic testing, and precision medicine. The terms are provided alphabetically, with illustrations of several of the key concepts.

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Addressing Suggestibility as a Psychological Phenomenon in Clinical Trials

Addressing Suggestibility as a Psychological Phenomenon in Clinical Trials
Published: by WIRB-Copernicus Group

Modern clinical trials increasingly rely on technologies to help accelerate startup, capture endpoints, and facilitate recruitment. In the midst of this technological revolution, it becomes increasingly important to understand patient perspectives and to anticipate how subjects in research studies may be impacted by the presence of digital tools, devices, and mobile health applications in clinical research.

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Genetic counselors at the forefront of helping researchers brace for the silver tsunami of CNS disorders

Genetic counselors at the forefront of helping researchers brace for the silver tsunami of CNS disorders
Published: by WIRB-Copernicus Group

Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.

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Returning Study Results to Research Participants: Best Practices for Preparation and Institutional Review Board Oversight

Returning Study Results to Research Participants: Best Practices for Preparation and Institutional Review Board Oversight
Published: by WIRB-Copernicus Group

Read this white paper, co-authored by the Center for Information and Study of Clinical Research Participation (CISCRP) to learn about the current best practices for the content and preparation of plain language summaries, and the current guidance for how sponsors should work with Institutional Review Boards (IRBs) which have oversight of the clinical trials for which the summaries are provided.

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Written Procedures for IRBs: What Does the New Final Guidance from FDA and OHRP Mean to You?

Written Procedures for IRBs: What Does the New Final Guidance from FDA and OHRP Mean to You?
Published: by WIRB-Copernicus Group

In May 2018 the U.S. Food and Drug Administration (FDA) and the U.S. Office for Human Research Protections (OHRP) issued final guidance titled Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs. The 21st Century Cures Act requires the Secretary of the Department of Health and Human Services (HHS) to harmonize differences between the HHS human subject regulations and FDA’s human subject regulations.

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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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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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