Newsletter | August 1, 2022

08.01.22 -- Novartis Lights A Beacon Of Hope For Diversity And Inclusion

 
Featured Editorial
Industry Insights
Sufficient Sample Threshold For Effective Bayesian Applications

Discover the sufficient information threshold: a conceptual point that can enable us to begin asking questions about the efficiency, ethical quality, and effectiveness of a clinical study.

A Successful Approach To Quality Oversight Visits

Sponsors and CROs employ CRAs to monitor clinical study sites. Because most site monitoring is done in the field, it is challenging for study managers to know and understand if CRAs/monitors are conducting their duties effectively and efficiently. Many study sponsors therefore employ co-monitoring/oversight visits to directly evaluate CRA performance and facilitate training. The following process can help to achieve successful co-monitoring/oversight visits.

How Standardized Terminology Can Accelerate Global Regulatory Performance

Watch this panel of regulatory experts taking part in an interactive roundtable examining the benefits of establishing standard terminology and its potential to help significantly improve regulatory quality, data accuracy, and efficiency.

Successfully Shipping Lifesaving Treatments For Humanitarian Aid In Ukraine

As part of a humanitarian effort responding to the ongoing crisis in Ukraine, shipping critical compassionate use medicinal products and supplies had several challenges to overcome.

Sponsors Are Selecting Fewer Clinical Research Sites: Here’s How To Be One Of Them

Discover why clinical trial sponsors and CROs are moving away from the traditional approach of working with a large number of trial sites and are instead concentrating on investing more time and money in fewer, more select sites.

Featured Editorial
Industry Insights
BYOD: When, Why, And How

This article gathers substantial information on BYOD, describing the several technical options and showing the numerous advantages of such an approach for both patients and clinical trial sponsors.

Recent Advancements In Glioblastoma Studies

When it comes to glioblastoma, learn why it is important to deliver well-managed trials while also helping sponsors find a treatment for this highly aggressive cancer.

The Fallacy Of Footnotes Within Clinical Protocols

Discover how including footnotes is a common practice and one that contributes more to noncompliance than just about any other facet of the protocol.

Decentralizing Trials Puts Diversity At The Center Of Clinical Research

Underrepresentation in clinical trials presents serious challenges to public health. Find out more in the available article.

Staying Within The Guardrails: How To Push The Boundaries In A Highly Regulated Industry

Amy Kissam-Sands, senior vice president of clinical operations, John Bell, chief quality officer, and Dr. Kristin Murphy, senior director and global head of the Change and Adoption Center of Excellence, discuss how to work within the regulatory guardrails when establishing a risk assessment framework.

New Podcast Episode
Industry Insights
Integrated CPU And Bioanalytical Services Deliver Reduced Cycle Time And Cost Savings For Early-Phase Trial Sponsors

Explore how efficiencies are critical to the support of trial sponsors that are managing multiple-cohort trials and those that are re-examining old compounds for new applications.

Smart Packaging In Clinical Trials: The Power Of Adherence Data

Individual data points over time can provide precise drug dosing histories that enable better understanding of protocol adherence, safety, efficacy, PK/PD, and a drug’s exposure-response relationship.

Measuring The COVID-19 Effect On Clinical Trials

From making sites inaccessible to the unprecedented development of vaccines, COVID-19 has permanently changed the nature of clinical research. This white paper assesses how well industry R&D has performed and what, if any, lessons have been learned.

3 Simple Steps To Manage Multiple Protocol Versions In A Single Study

Managing protocol versions at the site level and the broader protocol amendment at the sponsor level go hand-in-hand. Discover why neither is simple, but both sides of the equation must be taken into consideration when designing the study.

Solutions
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