Newsletter | July 28, 2021

07.28.21 -- No CMOs Or CROs: A Unique Approach To Cell Therapy Development

 
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Interventional Clinical Trial Or Registry Study? Writing Protocols That Demonstrate The Difference

The critical difference between these two study designs is whether the intervention occurs because it is a component of participation in a research protocol, or because a clinical decision was made that the intervention was the appropriate treatment option. In this article, we will address how sponsors and investigators can design research protocols that clearly indicate whether the clinical intervention is occurring within or outside of the context of the research, and why this distinction is critical in ensuring regulatory compliance.

Building The Connection Between Sites And Sponsors For Decentralized Clinical Trials

The COVID-19 pandemic proved that patients could participate in clinical trials using video calls, apps, wearable devices, and visits to their local physician, not just by visiting the research site in person. However, these hybrid decentralized trials work best when there are software integrations between research sites and their sponsors. So, how do you set up the site-sponsor connection and make decentralized trials effective and secure?

Drug Repurposing Trends And Strategic Approaches For Shortening Timelines

As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible.

Is BYOD Right For Your Clinical Trial?

Researchers are increasingly exploring bring your own device (BYOD) strategies, and while trials have successfully deployed this model for studies collecting key endpoint data, some CROs and sponsors are still hesitant because of the absence of regulatory guidance and the unknowns related to patient acceptance. This article discusses some of the key considerations for sponsors who are deciding whether a BYOD strategy is right for their trial.

Minimizing Luck In Study Feasibility Part 1: Best Practices

Industry statistics reveal that up to 86% of clinical trials do not reach recruitment targets within their specified time periods. To turn that number around, sponsors should conduct feasibility studies starting with protocol development and study design. In doing so, they will be able to effectively identify countries, study sites, and investigators for conducting the research.

Developing A Data Strategy For Clinical Trials

Data are the most important asset that a pharmaceutical or biotechnology company has, and the number and complexity of sources of data in clinical trials is increasing all the time; At the same time, there is increasing pressure to deliver high-quality data with accelerated timelines. This white paper describes a standardized approach to developing a data strategy that can be customized to a company’s current needs and can be adjusted as those needs change.

Accelerating Clinical Trials: The New And Future Normal

Inefficient interactions between clinical trial stakeholders play a large role in the time needed to bring a new drug to market. The pandemic is forcing this to change. SIP is facilitating these efforts.

eSource As Direct Data Capture

Direct data capture (DDC) is one of the four types of eSource and is often what people first think of as eSource. Some technology providers believe that electronic data capture (EDC) systems can be used as eSource, where the web-based EDC system is carried around on a laptop, or potentially a tablet, and data are entered directly into this system. The big problem is that such EDC systems are designed for the sponsor and don’t consider site preferences or workflows.

GrantPlan: Making Fair Market Value A Reality

Building an accurate budget for a clinical trial comes with a host of challenges. These include, but are not limited to, intricate protocols, large enrollments, shortened timelines, and global sites. By using a benchmarking tool that uses a global data set, experts can develop fair market value (FMV) costs.

Virtualizing Clinical Trial Oversight: The COVID-19 Effect

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

Biologics: The Key To Next Generation Dermatology R&D?

Biologics present new treatment options for dermatology patients who haven’t seen positive results from traditional treatment methods, such as topicals, phototherapy, or traditional drugs. This paper explores the evolution of biologics within the dermatology landscape, with an emphasis on clinical trial considerations for sponsors developing biologics agents.

Understanding Your Customers’ Outsourced Service Roles And Responsibilities

ISR was contacted by the vice president of content marketing at a Top 5 global CDMO with the question, ‘How do we better understand our customers’ roles and responsibilities as they relate to outsourced contract manufacturing services?’" The client had three goals with this question. 

Prostate Cancer Clinical Utility Study

To further enhance their prostate cancer test, a multinational healthcare company needed to compare its noninvasive urine test against biopsied tissues. But the logistics of identifying 2,000 patients and collecting tissues at 21 U.S. urology centers within six months was daunting. Read how with a quick response by Catalyst and the geographic alignment of the team the study was completed within a short window of time.

The Case Of The Elusive Protocol

A client required a chart review to evaluate survivability of pediatric patients with a rare metabolic bone disorder. By trying different protocols and overcoming complex issues of informed consent that had to be resolved before the study was successfully completed, they were able to successfully deliver a final clinical study.

Early Licensure Of A Breakthrough Cancer Drug Gives Hope To Patients

No clinical supply request could be a higher priority than that of a physician urgently seeking an investigational cancer drug for a patient who has exhausted all treatment options. 

Importing Clinical Supplies Into Japan

Rich Nelson, senior manager, global logistics, recently discussed the precision with which clinical supplies and the documents accompanying their import into Japan must be prepared. In this article he covers the commercial invoice valuation of clinical kits and clinical logistical considerations for Japan.

Specialized Scientific Support Streamlines Clinical Trials

As the pharmaceutical industry evolves, clinical studies have become more complex while timelines and quality standards have become more stringent. Achieving appropriate scientific oversight and thorough and efficient sample management throughout studies are challenges that many pharma and biotech companies encounter. In this Q&A we explore a highly specialized outsourcing model that address these challenges.

Wearable Data Gone Awry: Cautionary Tales From The Clincial Research Trenches

During this fireside chat, data experts from ActiGraph, VivoSense, and Elektra Labs share cautionary tales of data collection gone awry and how the teams found creative solutions for the problems at hand. Panelists recount real life examples of data collection efforts that missed the mark and provide strategies, tools, and guidance to help clinical teams avoid common missteps in the first place.

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