Moving Beyond Traditional CTMS to Unlock Value in an Outsourced Model

Published: January 2023 by eClinical Solutions

The traditional Clinical Trial Management System (CTMS) was designed to view and keep data within the walls of either the sponsor, the Clinical Research Organization (CRO) or data vendors. Historically a CTMS was able to sufficiently handle clinical trial data as there were fewer data sources. However, the proliferation of data sources and the rise of outsourced trials changed how CTMS is defined and called into question whether they are fit for purpose in today’s world.

This new white paper unpacks the evolution of CTMS and its role in modern-day clinical trials. It highlights how to chart the best path forward in the growing complexity of the outsourced model and how to ensure appropriate oversight of clinical trial data and risk-based strategies so you can ultimately trust the data to make crucial decisions. Learn More

Safeguarding Trial Data Privacy in Remote Environments – Overcoming Confidentiality and Security Concerns in Decentralized Trials in 10 Steps

Published: January 2023 by PCM Trials

Sponsors and CROs are required by GDPR and HIPAA to protect the confidentiality and data of participants in clinical trials. Failure to do so carries significant risks including the potential for major fines. While decentralized trials historically have been perceived as inherently more risky from a cybersecurity standpoint due to their remote nature, that’s not necessarily the case. This paper explains why. Learn More

The FDA Steps Up Pressure on Sponsors to Increase Diversity in Clinical Trials — How Decentralized Clinical Trials Can Help

Published: December 2022 by PCM Trials

The FDA has been advocating for increased diversity in clinical trials for decades, yet certain groups remain woefully underrepresented in many studies. But it appears we are at a turning point where talk about increasing diversity and inclusiveness is turning into action, and real change is afoot. This paper explores the reasons behind the shift and how decentralized clinical trial methods can enable sponsors and CROs to recruit and retain more diverse participants. Learn More

Data Safety Monitoring Boards/Data Monitoring Committees Management Complete Handbook

Published: October 2022 by Ethical

DSMBs, DMCs and Steering Committees have existed for a number of years. Regulatory guidance from both major agencies, the FDA and the EMA were issued to advise sponsors and investigators on the good use of such committees.

Abundant information can be found about when, why and how to set up and use DSMBs but we feel that there was still a need for regrouping all that information into this single integrated handbook. Learn More

Choosing a Partner for Remote Clinical Trials: 10 Questions to Ask

Published: October 2022 by PCM Trials

If you’re like a growing number of sponsors and CROs, you already recognize the many benefits of conducting a hybrid or fully remote clinical trial. However, not all remote visit providers are the same. So how do you decide which one is right for your next trial? This whitepaper offers 10 questions to ask of prospective partners to ensure they have the capabilities and experience to meet your needs. Learn More

Why eConsent Primes Patients & Studies for Success

Published: September 2022 by Medable

According to a survey conducted by Florence Healthcare, 47% of research sites had adopted eConsent by December 2020, just 8 months after the WHO declared an official pandemic. By July 2021, 75% of research sites had either used it or were looking into it.

In conclusion — a decentralized consent process is here to stay.

Learn why Medable's Total eConsent offering is the industry-leading remote consent technology, and how it can reduce your enrolment timelines by 50%. Learn More

New Applications, New Use Cases: The Expanding Need for Endpoint Adjudication

Published: August 2022 by WCG

Endpoint adjudication is nothing new. Sponsors often turn to endpoint adjudication committees (EACs) for large, complex studies, but they aren’t limited to large trials anymore. In recent years, we’ve seen a growing trend to leverage EACs in new ways. The goal, however, remains the same: to reduce bias and increase accuracy of clinical trials. In this paper, we will talk about factors to consider when determining the need for an adjudication committee. Learn More

Decentralized Trials Are Better Understood, but 5 Misconceptions Persist

Published: August 2022 by PCM Trials

Decentralized clinical trials became better understood after sponsors and CROs turned to them to rescue studies during the pandemic, but several misconceptions persist that are standing in the way of wider adoption of DCTs and the value they bring, including providing a more diverse range of participants access to potentially life-saving drugs.

This whitepaper lists five common concerns about DCTs and how a leading provider of mobile research services, PCM Trials, addresses them. Learn More

Making Clinical Research Inclusive: Strategies to Include the LGBTQIA+ Community in Research Trials

Published: July 2022 by WCG IRB

In this paper, we will talk about why it is important to collect information in clinical research studies about gender identity and sexual orientation and will discuss specific ideas for making studies inclusive of and respectful to the LGTBQIA+ community. Learn More

Establishing a Foundation for a Holistic RBQM Strategy

Published: June 2022 by eClinical Solutions

This whitepaper highlights why the industry is shifting from Risk-Based Monitoring (RBM) to Risk-Based Quality Management (RBQM), and how sponsors can build a scalable approach that protects trial participants, upholds study integrity, and increases operational efficiencies. Learn More

How Sponsors and CROs can Fully Benefit from the Permanent Shift to Decentralized Clinical Trials Brought About by the COVID-19 Pandemic

Published: June 2022 by PCM Trials

How can you benefit from the permanent shift to decentralized clinical trials brought about by the COVID-19 pandemic? Learn about all the benefits in our Lessons Learned guide today! Learn More

Tips for tailoring eConsent for Optimal Patient Centricity

Published: May 2022 by Medable

Over 70% of potential research participants live >2 hours away from a research site, & patient drop-out rates can reach 30% depending on the therapeutic area. Download the white paper to discover how to optimise eConsent for maximum patient centricity. Learn More

Increasing Diversity & Equity in Medical Care & Clinical Trials

Published: January 2022 by WCG

The good news is that diversity and equity programs are on the rise. They are urgently needed across healthcare initiatives – including clinical trials. How do we create trust, engage minority patients and reduce access barriers to medical care and the benefits of clinical trials? Learn More

Checklist for Selecting an Electronic Data Capture (EDC) System and CTMS that Your CRO Will Find Easy to Use

Published: April 2022 by Institute of Biostatistics and Analysis

The Institute of Biostatistics and Analysis' EDC Systems Guide will help you find the software that saves you time, money and nerves and that will maximally support your clinical studies. Learn the importance of well-designed EDC software and what features such a system should have to help you smoothly navigate through your clinical trials without unnecessary hiccups. Learn More

Overcoming Enrollment Challenges in an Overcrowded Clinical Research Landscape

Published: April 2022 by WCG

The way that we conduct clinical research has been changing since the onset of the COVID-19 pandemic. What factors are contributing to study enrollment challenges for sites and sponsors? What solutions can we as an industry leverage to overcome those obstacles? As an industry, we are at an inflection point. We can’t keep doing things the way we’ve always done them; we must do better. Learn More

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

Published: March 2022 by WCG IRB

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

The Basics of the Individual Expanded Access Request Process: A Resource for Physicians

Published: February 2022 by WCG IRB

Expanded access can appear to be a daunting endeavor, especially for those physicians not part of an institution or without an established relationship with an institutional review board. This paper will help provide guidance on starting the expanded access request process for those physicians who want to provide an expanded access option to their patient as quickly as possible. Learn More

The Clinical Development Digitization Guide

Published: February 2022 by eClinical Solutions

Take a deeper look into the key components of preparing for the digitization of today’s clinical trials in this new guide. You will learn the necessary steps that organizations must take to embrace transformation processes that will help usher in a new way forward for clinical trials. Learn More

The Centricity of Decentricity: Breaking Down the Basics of Decentralized Clinical Trials

Published: November 2021 by Medable

Patient recruitment, retention, diversity, safety, and data collection & analysis are all factors driving the need for radical innovation in clinical drug development. This need has been made painfully apparent during the current COVID-19 pandemic.

We can no longer ‘do the same thing and expect a different result’; it’s time to take giant steps forward. This White Paper outlines the methods Sponsors, Sites & CROs can adopt to digitally transform their protocols for improved scientific outcomes. Learn More

Decentralized Clinical Trials – How to Deliver the Complex Efficiently

Published: November 2021 by MRN

Supporting patients and sites is the goal of decentralized solutions in clinical trials – increasing recruitment and retention for sites and making participation less burdensome for patients and families.

This free whitepaper, Decentralized Clinical Trials- how to deliver the complex efficiently, will give you an inside view into key questions and considerations stakeholders need to be asking when developing decentralized visits that will result in efficient and safe delivery for patients. Learn More

Immunology Trials: Innovation Brings Hope, Fresh Challenges

Published: November 2021 by WCG

The cost of developing drugs continues to escalate. Estimates vary, but the Tufts Center for the Study of Drug Development estimated the out of pocket pre-tax costs to be $1.4 billion per approved new product in 2013 dollars. It is not unreasonable to assume that this has continued to rise over the intervening years. In view of these rising costs it is more crucial than ever before that Sponsor companies try to mitigate against failure and delay in their drug developments.

In this whitepaper, WCG explore aspects of immunology clinical trials that deserve particular focus in order to provide the greatest opportunity for success. Learn More

How-to-Guide: Complete Reference Book on Protocol Deviations Process

Published: October 2021 by Ethical GmbH

Improper Protocol Deviation management is costing the clinical trial industry millions of dollars per year. This represents substantial safety and quality risks that add new additional burdens for clinical teams all over the world. This Handbook (30 pages) explains the overall Protocol Deviations assessment process, lists the involved parties and describes the various methods/actions provisioned by regulations. We also discuss tools and procedures that may alleviate the burden and improve the outcome of Protocol Deviations management. Learn More

More Than Good Intentions: Diversity, Equity & Inclusion Requires a Program-Level, Strategic Framework

Published: September 2021 by WCG

Sponsors understand the importance of diversity, equity and inclusion (DE&I) efforts and have begun to implement them in their trials, but diversity in clinical trials has yet to be achieved.

To address this gap between aspiration and execution, sponsors — as well as sites and CROs — must recognize that DE&I is not merely another project. Neither is it a series of tactics. It is a systemic, top down transformation that must be managed strategically at the program level. The DE&I strategy must be communicated and implemented across your trial sites, including referral sites. It needs to extend into the nearby community-based sources of potential patients. Most importantly, no one can execute a diversity strategy alone.Learn More

Guide to Rethinking Your Imaging Strategy

Published: September 2021 by Medidata

While the use of medical imaging in clinical trials is rapidly increasing, the wave of M&A activity across key imaging players has created confusion for clinical trial stakeholders. This guide provides eight parameters sponsors, sites, and CROs should focus on to avoid the pitfalls in this disrupted landscape and ensure an optimal imaging strategy for your trials. Learn More

The Challenge of Overreporting: A Fresh Perspective from the FDA

Published: August 2021 by WCG

In a recent WCG webinar, Steven Beales, Senior Vice President, Scientific and Regulatory at WCG, facilitated a conversation with FDA leaders, Robert Temple, the Deputy Director of CDER, and Jacqueline Corrigan-Curay, the Director of the Office of Medical Policy. They discussed overreporting SUSARs and the impact on patient safety. This whitepaper is based largely, but not solely, on that conversation. Learn More

Modernizing Clinical Trial Oversight: The Path to Clinical Operations Excellence

Published: July 2021 by Medidata

The rising complexity of clinical trials and pressures resulting from the COVID-19 pandemic have forced sites, sponsors, and clinical research organizations (CROs) to adopt remote and risk-based approaches for clinical trial execution. With the increasing prevalence of decentralized clinical trials, the industry is now poised to fully embrace and implement risk-based quality management (RBQM) approaches to trial execution and oversight.

This white paper outlines the current state of RBQM in virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.. Learn More

Clinical Trials are Better, Faster, Cheaper with Big Data

Published: July 2021 by Medidata Acorn AI

What if researchers didn’t need to recruit a control group and could offer the experimental treatment to everyone who agreed to be in the study? In this white paper — developed in partnership with MIT Technology Review — you’ll learn how biotechnology companies are leveraging Medidata’s detailed information from 23,000+ trials and 7 million patients to create external control arms and accelerate the clinical trial process. Learn More

Don't Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise

Published: May 2021 by WCG

Whether the focus is endpoint adjudication, aggregate data monitoring or safety assessment, the clinical and device development industry clearly understands the value of establishing expert scientific committees to provide oversight on study data. These expert committee assessments provide validation on clinical data as additional support for regulatory submissions and commercial strategy. What is less well understood, however, is the importance of independent expertise. Without independent expertise, sponsors risk biased decision-making, conflicts of interest, potential clinical delays and squandered resources that could otherwise be avoided. Learn More

How-to Guide: Governing and Maintaining Standards for Collecting Clinical Data

Published: May 2021 by Veeva

Investing in data standards plays a huge role in improving the quality of clinical studies. But often, people don’t use the standards correctly, there are too many variations, or the standards keep changing, preventing you from running efficient trials.

Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Learn More

Opportunities to Accelerate Decentralized and Digital Trials

Published: May 2021 by eClinical Solutions

Take a deeper look into the current state of data sources, organization, and analytics in this new whitepaper. You will learn about their impact and the opportunities that exist to accelerate decentralized and digital trials. The paper includes insights on how 149 life science organizations are managing drug development data volume and diversity, existing challenges that impact clinical performance and efficiency, and the opportunities to accelerate digital transformation leveraging technology platforms and new processes. Learn More

Save the Data. Protect the Patients. Prepare for What Comes Next.

Published: April 2021 by WCG

The clinical trial environment faced a massive disruption in the wake of COVID-19, the scope of which was both unprecedented and incalculable. Clinical trial operators were in triage mode. There was no tested playbook for a pandemic, no standard operating procedure. And almost everything depended on sites. So how will clinical trial stakeholders continue to adapt in a (post-) pandemic world? Learn More

The Power of More Re-Imagining the Traditional Business Model for Oncology Clinical Research

Published: April 2021 by WCG

Complex challenges provide ample incentives to re-imagine the traditional business model – rising costs, shifting resources, increased pressure and “new normal” virtual settings. Motivated clinical research leaders want increased focus on patient care along with faster study starts, more patient access to trials and better performance while reducing costs and staffing burdens. Our recent webinar discussed industry trends as well as obstacles and new, practical approaches to achieving success. Learn More

Data Privacy in Clinical Trials: A Best Practices Guide

Published: April 2021 by Egnyte

For high-growth institutions with limited resources and bandwidth, the question arises: what should you do to comply with international and regional data privacy regulations?

Determine your best approach to data privacy with this whitepaper from Egnyte. Learn More

The Essential Guide to a Fourth-Generation eTMF

Published: March 2021 by Agatha, Inc.

Electronic systems for managing clinical study documentation first emerged in the 1990s and have evolved through several generations. Today, we have entered the fourth-generation of the eTMF system. This guide walks through the changes over four generations and aims to help clinops professionals understand what constitutes a 4G eTMF, how to compare alternative systems, and offers tips to put one into production quickly. Learn More

Endpoint Adjudication Charter Guide

Published: Mach 2021 by Ethical GmbH

A complete guide to creation and management of the Endpoint Adjudication Charters. Endpoint adjudication charters are a key element for the setup of quality Adjudication procedures and have been developed in various formats. We at Ethical have performed a thorough review of dozens of endpoint adjudication charters in order to build the present guide. Learn More