Newsletter | November 18, 2020

11.18.20 -- Janssen Study Shows How To Create Patient Diversity In Trials

 
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Tips For Planning And Executing Successful Critical Care Trials During COVID-19

COVID-19 has impacted the clinical research landscape completely, prompting special attention toward critical care studies that require a nuanced approach to patient-centricity and patient safety measures. Through our expertise and experience with critical care studies, we’ve been able to leverage our lessons learned into successful strategies that mitigate risks exacerbated by the pandemic.

Digital Health Innovation: The Predictive Impact Of Curated Real-World Data In Times Of Change

The projected costs of healthcare in the United States due to the novel coronavirus, or Sars-COV-19 (COVID-19), are eye-opening. One critical question is the extent to which digital technologies can be useful in informing our understanding of what works in healthcare delivery and what does not. Access to more complete data is crucial to empower a diverse range of stakeholders with the knowledge and ammunition needed to make informed choices about expenditures and the use of scarce healthcare resources.

Not Like Everyone Else: Unique Challenges For Small And Emerging Biopharma Companies

Small and emerging biopharma companies are conducting almost 50 percent of the clinical trials in the United States today. Unlike “Big Pharma,” small companies are usually working with lean teams, limited resources, and minimal infrastructure. In this paper, we explore some of the unique challenges for clinical development teams and solutions that can reduce the pressure on teams and timelines.

COVID-19 Guidance For eCOA From The Critical Path Institute ePRO And PRO Consortiums

COVID-19 has forced a reckoning in how we conduct all aspects of our lives; and clinical trials are no exception. The Critical Path Institute ePRO and PRO Consortiums — precompetitive, collaborative groups of eCOA providers and sponsors who work together to advance the science of electronic data capture — recently released a joint assessment and guidance for those using eCOA in clinical trials.

How Technology Is Enabling Advancements In The Assessment Of Patient Safety

Pharmacovigilance (PV) activities must be carefully planned from the outset of the drug development process. Read more about available process automation solutions available and if your company could benefit from working with external partners to manage PV activities.

Veeva 2020 Unified Clinical Operations Survey Report

Industry research shows sponsors and CROs are accelerating the move to unify systems and processes, while COVID-19 prompts an urgent need to keep existing trials on track and speed new studies.

Harness Site-Based eISF For Remote Site Access And Monitoring

The ability to access and collaborate with a research site is essential to the success of every study. A disconnected mix of on-site visits, email communications, and portals restricts site access and document exchange for sponsors and CROs alike. Read how remote site access, source document review/verification, and streamlined workflows transform essential clinical trial processes.

Evaluating And Qualifying Temperature Managed Shippers

The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber — from packaging, handling, storage, and distribution of temperature-sensitive investigational medicinal products (IMP), all the way to the investigator site. This ebook provides insight into how we qualify shipping options with a case study example of a “return and reuse shipper pilot” that delivered very positive results.

Intelligent Trials Success Stories

Clinical trials are getting increasingly complex, challenging their very planning and execution. To meet these challenges, AI-enabled technologies and advanced analytics become a true necessity. In this ebook, explore intelligent trials use cases for enterprise sponsors, midsize and emerging sponsors, and CROs. Whether you’re managing a portfolio or looking to ensure the success of a single trial, our unique data, advanced analytics, and resulting insights can help every trial achieve its full potential.

The Art Of Recognizing Clinical Supply Risk Factors

No two studies are the same, and each clinical supply project carries unique risks. Experienced supply chain managers know that certain study characteristics are often leading indicators that can anticipate a supply project will be complex in nature. Watch the webinar to learn about aspects of the study protocol that can directly influence clinical supply strategy.

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