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

Synthetic Control Arm in Clinical Trials

Published: February 2021 by Acorn AI™

This white paper discusses the concept of the Synthetic Control Arm® (SCA®), which is a type of external control that is generated using patient-level data from patients external to the trial. SCA® is designed to improve the interpretation of uncontrolled trials and enable better product development decisions. A series of case studies are provided to highlight the different ways a SCA® has been used. Learn More

Guide to Maximizing the Benefits of a Unified Clinical Data Capture and Management Platform

Published: February 2021 by Medidata

COVID-19 has highlighted bottlenecks and obstacles to data capture, monitoring, and management.

The new paradigm of remote visits and virtual trials, the growing pressure to leverage an expanding set of research, clinical, operational and real-world data, and the shift to risk-based monitoring demand new data management strategies.

Download the guide to consolidate and manage study data for validity and reliability, understand the impact of your technology choices, and identify processes to ensure drug and device safety and efficacy. Learn More

Clinical Research Trends & Insights for 2021

Published: December 2020 by WCG

Looking ahead to 2021, we have a new outlook on how we can conduct clinical research with a new-found capacity for flexibility, collaboration, and a focus on the importance of both patient-centric research practices and diversity. In our 2021 prospectus, 23 industry experts from WCG share the important shifts, trends, regulations, and priorities that will inform clinical trial development in 2021 and beyond. Learn More

Preparing for a New Data Future: A Survey of Clinical Research Technology Decision Makers

Published: Dcember 2020 by Medidata

Medidata surveyed life science CTOs about how they perceive and choose clinical trial tech platforms. Discover why the benefits of unified platforms—cross-application data reporting, connected workflows, simplified virtualization, and reduced costs—appeal to CTOs, and learn about the future of technology for clinical development. Learn More

Traumatic Brain Injury: From identifying biomarkers to improving clinical trial efficiency

Published: November 2020 by ICON plc

The manifestations and effects of Traumatic Brain Injury (TBI) are varied and impact diverse populations — it is estimated that 69 million individuals suffer TBI each year. A better understanding of how TBI manifests, can lead to better identification of biomarkers, and the development of prevention and treatment strategies. Learn how digital health technologies are shaping the future of TBI clinical research. Learn More

People Behind the Platform

Published: October 2020 by LMK Clinical Research Consulting

Society evolves with technology, and the clinical research industry is no different; it uses technology to develop new tools and treatments to advance medical care. Many clinical research companies have transferred from paper-based trial master files (TMFs) and manual logs to electronic systems and eTMFs. These systems are utilized to assist in keeping documentation compliant and organized. Though these systems make it easier to classify and preserve documentation, they also require a lot of time and effort to ensure proper controls and maintenance. Due to the lack of resources, training and quality control, operating regulatory compliant electronic systems has become an industry-wide issue. Learn More

Complete Guide to eISF + Remote Site Access in Clinical Trials

Published: September 2020 by Florence

How clinical operations leaders leverage remote site access technology to enable remote monitoring, start-up, management, and SDR/V. This guide will show you best practices, how-tos, and insights for implementing your own remote site access strategy: what is the eISF and how does it enable remote site access, how you can select a platform that will work for you and your sites, how to maximize the benefits, and how to get your study sites on board. Learn More

Patient Support Solutions in Rare Disease During the COVID-19 Pandemic

Published: August 2020 by Clincierge

Rare disease sponsors face an uphill battle when it comes to patient recruitment and retention during the COVID-19 Pandemic. Clincierge improves clinical trial outcomes by providing safe and patient-centric, strategic travel solutions to reduce barriers to trial participation. Learn more about the challenges rare-disease patients face and how Clincierge coordinates reliable patient support solutions, which can transform a patient’s experience and improve clinical trials. Learn More

Rare Disease Clinical Development: Novel Approaches to Overcoming Operational Challenges

Published: August 2020 by Medidata

This six (6) part white paper dives into the challenges that biopharmaceutical sponsors face and presents a variety of solutions capable of streamlining the process to speed delivery of rare disease treatments to the market. Learn More

Study Startup Solutions Improve CRO Oversight Through Collaboration

Published: May 2020 by Oracle Health Sciences

This white paper defines CRO oversight, describes the importance of relationship building among stakeholders, and takes a look at innovative solutions for streamlining study startup a notorious bottleneck and a critical step toward managing study statuses in real-time. Learn More

Deploying Remote Site & Patient Support Staff in Response to COVID-19

Published: March 2020 by WCG

Uncertainty over the future impact and implications of COVID-19 continues to exacerbate the preexisting issue of under-resourced sites.

Overwhelmed and lacking proper bandwidth, many sites may not have the appropriate infrastructure to adapt to this everchanging situation. Strategically placed remote site and patient support can ease that burden by carrying out a customized support plan tailored to the unique needs of each study site. Whether offering remote support in any type of trial or ensuring safe proper procedures on-site, WCG's remote site staff can work within any study team to ease the burdens that threaten to keep new therapies from reaching patients. Learn More

Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation

Published: February 2020 by The Avoca Group

So often, inspections are a major source of stress in the clinical trial environment. This is especially true when processes involved in preparing for an inspection are reactive. But, it doesn’t have to be that way. Using industry-leading practices and resources enables a proactive approach to mitigate — or even eliminate — the pain points associated with preparing for inspections. Learn More

Ethical Biosafety Oversight of Gene Transfer Research

Published: October 2019 by WCG

The number of drug products under development that incorporate recombinant or synthetic DNA or RNA, viral vectors, and/or genetically-modified organisms (“GMOs”) continues to grow rapidly, and several such products have received marketing approval from the FDA. This paper focuses on important points to consider when planning to initiate clinical trials with these products at sites inside or outside the USA, if the research is subject to rules and regulations of the FDA and/or the National Institutes of Health (NIH) of the United States. In particular, we focus on the roles of Institutional Biosafety Committees (IBCs) and Institutional Review Boards (IRBs) in approving and facilitating study startup. Learn More

Advances in Oncology Extend Lives, but Lead to New Safety Considerations for Sponsors and Investigators

Published: October 2019 by WCG

From cardiovascular adverse events to complex dosing regimens, oncology trials present unique safety-related considerations. Left unaddressed, they could undermine a trial or put patient safety at risk. In this paper, we discuss some of those issues and how sponsors can best address them. Learn More

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

Published: May 2019 by WCG

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. Doing so also pleases regulators, who are increasingly putting a premium on patient-focused drug development. It doesn’t have to be difficult, but getting it wrong — or not doing it at all — can undermine a trial. Learn More

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

Published: May 2019 by WCG

Safety reporting may be the most inefficient aspect of clinical trials today. It’s also among the most expensive, costing sponsors more than $700 million per year. Most are not receiving the best value for their investment, and some don’t even know how much they are spending. 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. Learn More

Virtual Clinical Trials Best Practices

Published: January 2019 by WCG

In recent years, along side the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials. In the virtual trial model, clinical studies are focused on bringing the clinical study directly to the participant and allowing data collection to be completed in a participant’s home or local community. 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. Learn More

Invert to Convert: Rethinking Patient Recruitment and Enrollment Strategies

Published: January 2019 by WCG

Despite all the advances in science, medicine and technology, clinical trials are stuck in a rut: Most have trouble meeting enrollment targets. It’s an analog problem in a digital world. The current approach-starting at the top of the recruitment funnel simply doesn’t make sense anymore. Perhaps it never did. Learn More