Newsletter | October 14, 2020

10.14.20 -- What Do Small Sponsors Look For When Choosing A CRO?

 
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Developing Gene-Based Therapeutics

The regulatory, operational, and commercial forces that impact gene therapy development continue to evolve dramatically — not just in the U.S. but throughout the world. This paper explores strategic considerations for regulatory, operational, and commercial success.

Complete Buyer's Guide To The Modern Electronic Trial Master File (eTMF)

Implementing an electronic trial master file (eTMF) is critical for sponsors and CROs that want to reduce burden, increase study capacity, and enable more trials. However, many organizations are not equipped with a modern solution to realize the full benefit and future-proof operations. This guide serves as an in-depth overview of how a modern eTMF solution can impact your organization and the steps you can take to prepare.

ePRO And Agile Methodology: A Winning End-To-End Solution For Oncology Studies

In oncology clinical research, patient reported outcomes (PRO) have historically been collected on paper. This white paper describes a unique, agile ePRO deployment methodology used by a global clinical trial technology company, discusses the benefits of using ePRO in oncology trials, and explains why this agile process is beneficial for oncology trials.

The Journey From Production Line To Patient Exploring The End-To-End Requirements Of A Successful Cold Chain Operation

While the clinical trial landscape is always evolving, with an increase in biologics drugs being trialed, the need to supply patients with safe, compliant investigational medicinal product (IMP) remains unaffected. Read this article that explores the cold chain journey from production line to patient to learn how you can overcome challenges within your temperature-controlled supply chain.

Preventing Information Overload: Using Study Portals To Engage Site Staff

For many sites, the overabundance of communications through email, system notifications, or other means isn’t just common, it’s standard. To combat this, sponsors have been using study portals to employ a traditional mix of best practices and tailored communication styles. This approach works because it covers the core needs of all clinical trial sites while also addressing the two different types of site users.

Veeva 2020 Unified Clinical Operations Survey Report

COVID-19 has accelerated industry efforts to adopt new and more effective business models that drive trial performance. Findings show the industry is taking action to unify its clinical systems and processes to increase efficiency, quality, and speed in clinical trials. Read the report to learn more.

Ancillary Supplies: Clinical Trial “Must-Haves” That Require Early Planning

Ancillary supplies are a necessary component in every clinical trial, though these products are often perceived as secondary in importance to investigational medicinal products (IMPs). Janet Williams, senior director, global supply chain management, and Julie Hoffman, senior director of commercial strategy and execution, discuss why ancillaries are as essential as IMPs, and why sponsors should devote as much attention to early planning for ancillary supplies as they do for study drugs.

Minimizing Bias When Blinding And Masking Drug Products

Overcoming complex blinding and masking challenges in clinical trials requires a balance of strategy and adaptability. When conducting clinical trials, one of the most significant dangers to success is the presence of bias, which can be minimized using appropriate blinding and masking approaches. Dr. Paul Ingram, global director, strategic development and innovation, clinical supply services at Catalent Pharma Solutions, discusses the importance of blinding treatment allocations to patients and investigators in clinical studies, as well as physically masking products that are being tested.

Best Practices For Paper-Based And eRegulatory Sites

This ebook examines the use of electronic tools for maintaining regulatory compliance at research sites and recommends best practices to be applied to the use of those tools.

23andMe: Information Empowering Patient Action

“Genetics is about everybody, and this information is really fundamental to you and your health,” explains Dr. Emily Drabant Conley, vice president of business development for 23andMe, the first company to receive U.S. regulatory approval for their over-the-counter genetic ancestry and health tests. “If individuals are empowered with information about their genetic predisposition, it puts them in a position to take action.”

Solving Local Lab Data Challenges: An Optimized Process For Near Real-Time Normalization

In this webinar, an overview of a local laboratory standardization process will be given to demonstrate how these processes can be optimized. The standardization process described in this webinar aims to capture and report local laboratory data quickly, accurately, and cost-effectively.

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EDC Transformation Meet Today's Clinical Trial Needs
 

When electronic data capture (EDC) in clinical trials began, almost 30 years ago, it was revolutionary to clinical research. Since then, advances in science and technology are forcing the industry to consider new methods for collecting and using clinical trial data. The initial EDC systems were not designed to store and manage the influx of clinical data we are seeing today, and, frankly, will not be able to support trials in the future. Further, the current global environment is shining a spotlight on antiquated systems and processes and is compelling the industry to rapidly embrace new ways of approaching clinical development, and, specifically, data collection.