Newsletter | July 21, 2021

07.21.21 -- How One Biotech Is Taking An Innovative Approach To Alzheimer's Disease

 
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Clinical Studies Required For A 505(b)(2) Development Program

A very common yet very critical question for a 505(b)(2) development program is, “What clinical studies are needed to support the marketing application?” The clinical program required is very dependent upon the specifics of the new drug product and indication, and the studies necessary to gain approval can range from a single bioequivalence study to a more comprehensive Phase 2 and Phase 3 clinical program. Learn more about the scope of clinical studies for a 505(b)(2) in this article.

The Value Of Diverse Community-Based Hospitals In Clinical Research

In our latest blog, learn about the value of diverse community-based hospitals in clinical research and Elligo’s mission to connect primary care physicians and their patients with clinical research as a care option.

How To Close The “TMF Compliance Gap” With Advanced eTMF Archiving

The trial master file (TMF) compliance gap occurs when your CRO uses their eTMF system to manage your study’s electronic trial master file. When the study is live, the eTMF is generally secure and inspectable in the CRO’s eTMF system — especially if they are using an advanced eTMF purpose-built for TMF management. A solution that encompasses software and expert services for inspectable and affordable eTMF storage can turn the industrywide TMF compliance gap into a bridge that any organization can easily cross.

5 Key Takeaways: Drug And Device Development Secrets In The World Of Medical Aesthetics

New treatment options for medical aesthetic indications are in record-high demand, fueled by growing awareness of the effects of physiological and environmental aging and the influence of lifestyle on skin health. Premier Research explored this evolving landscape in depth in our recent webinar “Drug and Device Development Secrets in the World of Medical Aesthetics.” In this blog, we discuss five of the most important takeaways for creating a competitive, differentiated aesthetic development program.

How To Create An Effective Environment For Technology Transformation In Clinical Trials
Shifting to remote processes is part of a broader healthcare trend, but moving away from paper is very specific to clinical research. Most of the healthcare industry has already made this transition. To be successful, you need to go all-in on technology adoption, and it cannot be single-threaded or incremental. Organizations looking to create an effective environment for technology transformation can help make the process more seamless by taking into account three key considerations we cover in this blog.
Implementing Remote Trial Management: Proven Approaches For A Quick And Effective Launch

Remote trial management has never been more critical to ensure flexibility in your clinical operations. Industry experts Penny Manasco and Michael Smyth discuss key considerations for effectively launching remote trial management for current or upcoming studies. Learn how to choose a vendor that can provide you with the right solution to not only ensure your clinical trials maintain accuracy and compliance as they go virtual, but also help you innovate your approach to clinical trial management.

Virtual Approaches In Oncology Clinical Trials During COVID-19 And Onward

Patients living with cancer are among the most vulnerable during the pandemic, but sponsors and researchers understand oncology drug development must continue. This paper will discuss how COVID-19 is driving change in the oncology trial landscape and how these insights may shape the future of post-pandemic clinical development. Given the unique concerns of cancer patients, the scope of the discussion will focus on outlining innovative and flexible tech-enabled approaches and operational adjustments that can improve the patient experience.

How To Address Early Obstacles In Phase 1

What steps can sponsors and CROs take to position their early-stage studies for success and expedite their final market approval? In this article, we’ll explore three obstacles that researchers face early in Phase 1 studies, as well as some insight into how the right eClinical suite can overcome those challenges.

The Accelerated Evolution Of Clinical Trials In A Pandemic Environment

To explore the impact of the current environment on clinical trial management, we surveyed professionals involved in clinical trials at biopharmaceutical companies, medical device companies, and CROs based around the world. The research results provide valuable insight into how the COVID-19 pandemic is changing the way clinical trials are being conducted and identifies the key challenges and opportunities surrounding these changes.

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.

Seven Secrets To Patient Experience Breakthroughs

In this paper we explain how to use principles of behavioral economics to keep clinical trial participants engaged, adherent, and proud of their contributions to curing diseases.

2021 Predictions Getting Down To Business In Clinical Trials

The COVID-19 pandemic added new obstacles and complexity on top of the already difficult environment, creating enormous adaptive pressure on the entire clinical trial ecosystem, hastening adoption of new clinical research paradigms, and accelerating emerging trends. But will they sustain? In this paper, we will delve into hot topics impacting research today.

Respiration Rate Measurement With Philips Health Band In Adults With Lifestyle-Related Chronic Disease

The Philips Health Band (PHB) is a wrist-worn wearable device that leverages accelerometry and photoplethysmography (PPG) sensors to deliver sleep, cardiology, respiratory, and energy expenditure (EE) endpoints. In this study the respiration rate was evaluated for accuracy and performance in adults with (or at risk) for lifestyle-related chronic disease using the Philips Health Band.

Simplify Your Drug Delivery Supply Chain

To bring their lead candidate to patients with a serious, rare, and life-threatening disease, a clinical-stage healthcare company needed to move quickly with lacking resources. One integrated offering allowed for individual approaches to their drug substance, drug product, and clinical trial packaging needs.

Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice

Conducting a trial with a sponsor of choice is more important to sites than ever. See how a pharma company reduced investigator payment cycle time by 55 percent while decreasing their own administrative burden by 90 percent in this metrics-rich case study.

Virtual Study Training For Clinical Trials
The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster — check out our latest e-book on virtual study training to learn more today.
Resiliency In CRO Operations During The COVID-19 Pandemic

In this Q&A, QPS Holdings LLC chairman, president, and CEO, Ben Chien, Ph.D., reflects on the progress of the company’s growth from a small, three-person startup to a midsize CRO, the impact COVID-19 has had on drug development and clinical trials, and the way forward for CROs in the midst of a pandemic.

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