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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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Compensating Participants in Clinical Research: Current thinking NEW!

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

It is not uncommon for monetary compensation to be provided to research participants, 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 on how people make decisions about research participation, bring a new perspective; are payments to participants actually too low? This paper explores this question and whether we should worry much less about restricting compensation for research participants.

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Advancing patient protection through proposed Common Rule changes for informed consent NEW!

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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Steps to Paperless Research Sites

Steps to Paperless Research Sites
Published: by Complion

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

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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Single IRB Review for Multicenter Research: A Guide for Institutions

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

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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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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