Newsletter | July 20, 2020

07.20.20 -- The Benefits & Challenges Of Head-To-Head Trials

Featured Editorial
Industry Insights
Your 5 Questions About Enrollment Assistants Answered

Enrollment assistants ease site burden and increase patient engagement. Following are answers to five common questions about the use of this on-the-ground recruitment support.

Bayesian Methodologies To Address Clinical Development Challenges For COVID-19 Drugs, Devices, And Biologics

There are numerous challenges when designing COVID-19 trials including a lack of prior data for candidate interventions/vaccines due to the novelty of the disease, the evolving standard of care as knowledge accumulates on the COVID-19 disease, and emerging evidence from completed trials. Bayesian statistical methods are very well suited to address these challenges due to their ability to adapt to knowledge that is gained during a trial.

Developing Immunotherapies For Cell-Based vs. Non-Cell-Based Therapies

Both cell-based therapies and non-cell-based therapies are developed as immunotherapies and therefore share some similar challenges in development.

Six Strategies To Stretch Your Limited Drug Supply For Clinical Studies

These clinical packaging strategies can be used to help successfully manage the supply of an expensive drug product throughout the duration of clinical testing. Without doing so, there could be costly interruptions or extended delays that would have a devastating impact on a company’s timeline to commercialization.

Clinical Trials And Travel Tribulations: Improving Access And Outcomes For Patients And Caregivers, Sites And Sponsors

In this paper, we dive into the logistical and financial challenges that increasingly impact all clinical trial stakeholders — from patients and sites, to sponsors and contract research organizations (CROs). Yet with proper planning and the right partners on board, travel arrangements and reimbursement programs can make the trial and patient experience more comfortable and successful for everyone.

The Regulatory Evolution And Data Revolution In Medical Device Development

The life sciences and healthcare industries are among the most heavily regulated industries in the world. This paper looks at the current dynamic regulatory landscape within the medical devices sector and some of the current and future changes medical device organizations will need to adhere to. The in vitro diagnostics (IVD) sector is also going through regulatory change — a topic that is out of scope for this paper.

Getting Started With Remote Trial Management

At a recent clinical trials and COVID-19 webinar series, industry experts discussed the best strategy to make the transition from largely manual, paper-based processes to complete remote trial management. This Q&A shares some highlights and takeaways about how to get started with remote solutions.

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