Newsletter | February 22, 2021

02.22.21 -- UCB Uses Decentralized Trials To Manage Studies

 
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Bringing Clinical Trials To Patients With The Decentralized Model

Since COVID-19, which has had a huge impact on global clinical trials, sponsors, CROs, sites, and patients have pivoted to adapt to a more home- or community-based approach. Learn why bringing a trial to a patient’s home — with the help of home healthcare support, telemedicine and sensors, direct-to-patient drug shipments, and more — helps to minimize the barriers to recruitment and retention.

The Trials Of The Future Are Needed Now

A paradigm shift is underway in the world of clinical trials as more and more CROs and pharma companies investigate some type of decentralized trial. The adoption of novel approaches has been slow, but the COVID-19 pandemic has changed everything.

New Year: Ready To Restart Your Trial?

The industry is seeing amazing collaboration in the race for a COVID-19 vaccine, leading to greater productivity and increased efficiency. In this blog, learn more about why collaboration is important to trial master file (TMF) quality.

2021 State Of Clinical Trial Technology Industry Report

How are clinical operations leaders making strategic technology investments in 2021 and beyond? This report provides insights from more than 200 respondents to the annual Florence State of the Industry Survey, from dozens of stakeholders who are members of the Florence Executive Advisory Board, and more than 8,500 study sites and more than 8,000 sponsors using Florence.

Regulatory Compliance: An Increasing Burden On Sites

As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that today’s successful drug development plans often require more clinical studies than they did a dozen years ago. But a new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.

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.

Protected Ambient Sample Shipping

A leading pharmaceutical research company needed help supporting a two-year clinical study of progressive multiple sclerosis. In order to accommodate multiple sampling time points, the shipping kit needed to hold up to 17 test tubes in isolation, instead of the standard six or seven, and needed to maintain the test tubes within a very limited target temperature range despite exposure to extreme heat or cold for extended periods of time.

Global Pharma Company Dramatically Improves Collaboration, Communication, And Compliance In Trials

A Top 5 global pharmaceutical company wanted to help sites do everyday tasks more efficiently, making it easier for site staff to adhere to the protocol and deliver high-quality data. After evaluations and pilots, the company deployed IQVIA Technologies’ Investigator Site Portal (formerly DrugDev) in a four-phase approach that delivered benefits each step of the way.

Biosimilars: Top 4 Differences When Managing Clinical Trial Supplies

At first glance, planning a clinical supply chain for a biosimilar trial appears like getting ready for a traditional study. As in all clinical trials, the supplies team is responsible for making sure the investigational biosimilar drug makes it to the right patient, at the right time and place. Yet these studies do present some unique challenges for clinical supply chain professionals. This e-book outlines the top four differences in managing clinical supplies for biosimilar trials. These challenges make biosimilar studies anything but routine for clinical supply teams.

Reimagining Clinical Trials In The Era Of Cloud Computing: A Conversation

The widespread use of cloud computing has altered the clinical trial design process. Whereas three or four years ago it would take a statistician perhaps two or three days to design five clinical trial designs, a well-resourced statistician can now simulate and model well over 100,000 designs in less than 30 minutes. How does this affect the process of designing clinical trials?

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