Newsletter | March 15, 2021

03.15.21 -- The Asia-Pacific Region: A Hot Spot For Clinical Trials

 
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How Should You Prepare For Foreign FDA Inspections During COVID-19?

As the COVID-19 pandemic continues, it is important to understand the expectations of regulators about how to facilitate paper-based facility inspections in lieu of those performed on site.

Beyond The Buy: The Critical Role Of Data, Relationships, And Experience In Comparator Sourcing Success

Practical experience and having strong industry relationships not only impact the sourcing plan but can also affect the willingness of innovators and suppliers to make the requested product available.

Real-World Data Matters: Rallying Call For COVID-19 Insights Using Real-World Data

Vast amounts of clinical data are captured at the point of care. This real-world data (RWD) is a treasure trove from which researchers and clinicians can better understand the characteristics of the novel coronavirus and develop therapies, clinical guidance, and containment strategies. Unfortunately, much of COVID-19 RWD remains untapped. But this is soon to change.

Veeva Unified Clinical Operations Survey: Annual CRO Report

New research reveals that more CROs are taking action to meet the urgent need for faster clinical trials. Read the Annual CRO Report to learn what actions CROs are taking to streamline clinical operations.

Empowering Medical Coders With AI To Increase Efficiency And Accuracy

Pharma companies continue to seek ways to streamline their operations, and clinical trials were a common target in 2020 due to COVID-19. As anyone involved with clinical trial operations or data management can tell you, medical coding is an often overlooked element of the process that is ripe for improvement.

Three Considerations For Successful Global Sample Processing With A Central Laboratory

Sample preparation and processing are often crucial components in immuno-oncology and cell and gene therapy studies. Obtaining timely and high-quality processing services is an industrywide challenge, particularly within the context of global trials. This paper reviews three of the keys to success for global sample processing.

Speeding The Switch To Risk-Based Monitoring

The adoption of risk-based monitoring (RBM) is increasing as companies provide greater management support, staff training, and more sophisticated technology systems. Technology platforms that enable continuous monitoring with near real-time intuitive visualizations, analytic dashboards, and applications will allow issues to be identified and addressed early, improving study safety and efficiency.

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.

ePRO And Agile Methodology: A Winning End-To-End Solution For Oncology Studies

In oncology clinical research, patient reported outcomes (PROs) 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.

How To Select The Best Courier Around The Globe

As a leading biotechnology company's pipeline and global presence continued to grow, management of the supply chain presented challenges. Additionally, cost pressures demanded a tighter supply chain with better control over inventory levels, and there was a need for increased temperature monitoring of clinical supplies in transit. Learn how data-driven decisions allowed them to realize cost and performance improvements across the supply chain.

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