Newsletter | October 11, 2021

10.11.21 -- 3 Strategies To Engage With Patient Advocacy Organizations

 
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Putting Data To Work In A Pandemic

Even before the pandemic hit, clinical trials were beset by high failure rates due to poor site performance, recruitment difficulties, and data quality issues. As a business begins to dig itself out of a pandemic-led slump, sponsors need to know, now more than ever, where to find high-performing sites and how to ensure that their enrollment and data collection efforts are on target.

Referencing A Listed Drug For The 505(b)(2) Pathway

Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) NDA as an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

Self-Collection Of Blood Specimens In Clinical Trials

Blood self-collection devices are in various states of regulatory approval and their utility varies by the amount of blood they can collect, processing requirements by test, and the creation of tests validated to appropriate regulatory standards and guidelines. This article focuses on devices that can potentially enable patients to collect their own blood in their homes for clinical trials. Through technological innovation there are several devices under development for potential self-collection of dried blood spot and liquid blood samples.

How TMF Study Owners Can Provide Better TMF Management

Successful trial master file (TMF) management requires constant and careful attention to each process, procedure, and guideline. Here’s how a TMF study owner can fill your resource gaps to ensure your TMF is always inspection ready.

Paving The Way For Virtual Trials In Neurology: A Fully Remote ALS Study In 2015

The COVID-19 pandemic has completely changed the way we think about clinical research and care. Clinical trials, a vital component of the drug development process, were heavily disrupted because patients, often with weakened immune systems, could not visit hospitals and research sites.

Novel Uses For Oral Solid Doses Driving Lifecycle Management Strategies

With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.

Pharma’s Digital Awakening: Research-Ready Health Information And AI To Reduce Cost And Deliver Better Treatments

Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and, ultimately, improve customer satisfaction.

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.

Removing The Barriers To eConsent Adoption

Electronic consent (eConsent) technology has existed for nearly 20 years in various iterations. Read how sponsors overall have taken a cautious approach to using eConsent, piloting it on individual studies but refraining from incorporating it across all pipelines in clinical operations.

Quality Metrics: How To Add Value And Meet The FDA's Expectations

Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. 

How Direct-To-Patient Models Can Provide Clinical Supply Chains With An End-To-End Solution

Analyze the benefits and challenges of implementing direct-to-patient services in the clinical supply chain to help meet patient requirements, improve supply chain efficiency, and accelerate speed-to-market.

What Are Decentralized Trials And Why Do They Matter So Much Today?

The aim of decentralized trials is to encourage patient participation by reducing or eliminating the need for travel to sites. These trials are conducted remotely, with subjects needing far less, or no time, at the traditional clinic or hospital. This is only possible through the advancement of technology, driving an increasingly mobile user landscape than ever before.

Navigating The Changing Clinical Trial Landscape

The only way to map a course to a better future is to understand the reality of the current landscape and what perpetuates the status quo. To do this, insight was gathered from those involved in clinical trials. The output of this research reveals the challenges and priorities that will shape the journey to the future of clinical research.

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.
Pharma Sponsor Enlists Cenduit IRT To Rescue A Multicountry, Multisite Oncology Study

After go-live, the sponsor learned its study did not fit the existing interactive response technology (IRT) solution, affecting data quality, timelines, and drug supply shipments. The legacy system’s medication management algorithm could not support the required flexibility in the supply chain. The trial included an adaptive cohort design. Read how Cenduit delivered a high-quality study achieved through innovation, close client collaboration, and expert project management.

The Ultimate Guide To Decentralized Clinical Trials
This e-book reviews four critical steps CROs need to consider when looking to leverage decentralized clinical trial (DCT) technologies in order to adapt business processes to support today’s hybrid and decentralized trials.
Decentralized Clinical Trials For Research Sites

Although many clinical research organizations are talking about decentralized trials, few groups are talking about what decentralized trials mean for research sites. As a site-first organization, we wanted to share what we've learned about decentralized trials from the sites we work with. 

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