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

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By Ed Miseta, chief editor, Clinical Leader Cartesian Therapeutics has just 20 employees, but the company performs all its preclinical and regulatory work and clinical operations in-house. A few years ago, Cartesian also built a GMP manufacturing facility from the ground up. That gives the company its own quality management system and quality control labs. Learn how they did it. By Youbean Oak, Bill Woywod, and Paige Cooper, Guidehouse Due to insufficient sample sizes and a lack of granularity, traditional data analysis of rare diseases produces unreliable results. What can you do to learn more about patients with rare diseases? Leverage data from social media and other online sources! The internet offers a trove of public data waiting to be tapped into.

Article | By Jeffrey A. Cooper, M.D., and Lindsay A. Abraham, WCG 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. Article | By D’Anna Siegle, Florence Healthcare 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? White Paper | By Anil Kane, Thermo Fisher Scientific 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. White Paper | By Celeste A. Elash and Carol Tester, YPrime 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. White Paper | By Ashley Schwalje and Daniel Chancellor, Informa Pharma Intelligence 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. White Paper | By Hugh Donovan, Advarra 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. Article | Cognizant 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. Article | Encapsia 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. Article | IQVIA Technologies 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. White Paper | Medidata, a Dassault Systemes company 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. White Paper | IQVIA Biotech 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. Case Study | ISR Reports 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.  Case Study | Catalyst Clinical Research 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. Case Study | Premier Research 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. Case Study | Thermo Fisher Scientific 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.  Q&A | PCI Clinical Services 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. Q&A | LabConnect 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. Webinar | ActiGraph 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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07.28.21 -- No CMOs Or CROs: A Unique Approach To Cell Therapy Development - Clinical Leader
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