Newsletter | October 13, 2021

10.13.21 -- Decentralized Clinical Trials: Does Your Strategy Include These Facets?

 
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Best Practices Guide To Data Privacy In Clinical Trials

As life sciences companies grow, the regulatory compliance requirements and risks expand as well. These responsibilities extend beyond conventional health-related frameworks (e.g., GxP, HIPAA, etc.) but into the realm of data privacy as well. For high-growth institutions with limited resources and bandwidth, the question arises: What should you do?

Elevating Effective Outcomes With Companion Diagnostics

Companion diagnostics (CDx) is a keystone for pharma to create more precise drug therapies as personalized medicine accelerates. Here’s why a CDxcentral laboratory partner is necessary.

CRO Selection Taken Seriously

Industry Standard Research (ISR) asked over 500 clinical development outsourcers their level of agreement with the statement: My organization’s mix of CROs is not likely to change much in the next two years. This article not only offers insight into their responses, but also what is important to sponsors when looking to outsource clinical development work.

A View From The Clinical Floor

Adaptive designs allow more flexibility and control over the trial and, hopefully, will lead to defining the optimal strategy for the given therapy. Bayesian statistics is likely to dominate the future standard of trial design but does involve change in how clinicians interpret the results.

Patient-Centricity By Design

This white paper explores the additional benefits of decentralized clinical trials (DCTs) that take patient preferences and needs into consideration and include connected devices to drive greater efficiency and engagement.

Comparator Drugs: Meeting Speed-To-Market Demands

Phase 3 trials require a reliable and consistent source of comparator product, comedications, rescue medications, adjunctive therapies, and supplies.

Blood Disorder Clinical Trials: Adapting To COVID-19 Challenges

The spread of COVID-19 has heightened the potential risk of infection for patients suffering from blood disorders. Hematologist Dr. Robert S. Negrin, a new member of Biorasi’s growing Scientific Advisory Board, weighs in on understanding and adapting to changes to blood disorder trials and treatment during the pandemic.

Text Neck: Anatomy Of A Modern Spine Condition

Do you suffer from text neck? Learn what it is, along with the causes, symptoms, and treatments for this common condition, with detailed images showing the biomechanics and anatomical structures involved.

The Four Types Of eSource

“Doing eSource” is a mixture of removing the need for paper source and also utilizing the data that are already collected and stored electronically. This means we can split eSource into four different categories.

Considerations Regarding Noninferiority: A Case Study In Multiple Sclerosis

To illustrate the seven key elements that should be considered before selecting an noninferiority (NI) study design, this paper presents a case study examining the potential use of an NI design in a study involving relapsing remitting multiple sclerosis (RRMS).

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.

Expert Analysis Of Rater Discrepancies Allows Sponsor To Demonstrate Efficacy (Even With A Missing Endpoint)

Discover how a sponsor gained the confidence required to proceed with the development of their movement disorder compound.

Flexible Interactive Response Technology (IRT) Platform Solution For National Lung Cancer Trial

Trial design for a medicine trial to investigate treatment for non-small cell lung cancer presents unique challenges. These include the need for an IRT platform that can support the rapid incorporation of amendments and account for multiple or potential arms, which requires different lists of material types and dosages that could be prescribed to patients and supplied to sites. Cenduit’s highly configurable, flexible technology platform was the solution.

A CRO’s Road To ePRO Revenue

A global, full-service CRO had looked at the increasing demand and expected growth rates for electronic patient reported outcome (ePRO) technology and determined that the opportunity for an ePRO offering would be significant. This case study describes how a global CRO successfully added ePRO to its service offerings enabling them to provide a unified service to its sponsor clients while creating a new revenue stream for themselves.

Utilize Real-World Evidence For More Efficient Trials In A Regulatory Setting

Watch this webinar to learn best practices around external controls and making data-driven trial design decisions in a regulatory setting.

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