Five Benefits of Risk-Based Quality Management (RBQM) for Clinical Trial Data

Risk-based quality management methodologies address risk control and management during execution of a clinical trial. RBQM adoption has generated valuable benefits for project management and clinical operations, changing the way trial monitoring is done. However, data management activities are ideally suited for an RBQM approach as well. Today, we explore five benefits data managers can gain from implementing a risk-based quality management approach and the enabling applications.

Webinar: Advancing Your Neurodegenerative Biomarker Strategy Beyond Discovery

On April 15, we hosted the virtual conference, “Advancing Your Neurodegenerative Biomarker Strategy Beyond Discovery.” For study teams working to develop treatments for patients suffering from neurodegenerative diseases, the need to leverage new techniques quickly and effectively is imperative. This topic is vital, as nearly 50 million people worldwide suffer from Alzheimer’s or related dementia1, and 10 million are living with Parkinson’s Disease2.

A Creative Solution to Address the Biosimilar Boom

Identifying viable study sites presents a challenge in many clinical trials. Biosimilar development is especially challenging as the number of sponsors preparing to broaden access to today’s blockbuster biologics, by providing lower-cost biosimilar alternative, continues to grow. While this flood of research activity will make a significant improvement for patient access to breakthrough treatments, it has also created an increasingly competitive environment for finding suitable, experienced sites.

The July 2021 edition of the Labcorp Drug Development Decentralized Clinical Trials blog

In our previous edition of the blog, we highlighted our upcoming presence at DIA. Our focus at the show this year was patient diversity, patient equity, and patient engagement. The recordings from the show are now available, so this month we will point you toward those in case you missed them during the week DIA was live. We also have had requests for short videos describing our Labcorp DCT solutions, so we are happy to announce that we’ve release two videos that document the Patient Journey and the Sponsor Journey.

Risk Library: A Proactive Approach to Risk Management for Clinical Studies

Categorizing and centralizing cross-study, cross-functional risk data

Antibody Critical Reagents: Challenges and Risks in Their Lifecycle Management

Antibody critical reagents are crucial to regulated (GxP) drug development assays. Poor quality reagents risk generating inaccurate and unreliable results, while failure in supply can delay preclinical and clinical studies. Overall, the potential consequences are losses in time, money and reputation. Read on to understand the key challenges in antibody critical reagent production and supply as the first step to de-risking your product lifecycle.

Cell & Gene Therapy Answers: The Evolving Cell & Gene Therapy Landscape

We recently sat down with Maryland Franklin, Vice President and Enterprise Head of Cell & Gene Therapy at Labcorp Drug Development, to discuss key considerations for developing cell or gene therapies in today’s quickly expanding pipeline.

A Successful Remote Monitoring Strategy for Clinical Studies

The COVID-19 pandemic forced study teams to adapt, improvise and overcome as they faced the need to monitor clinical trials, sites and patients from remote locations. Moving forward, we see remote monitoring as part of a successful strategy for managing clinical studies. In this posting, we share “lessons learned” and best practices.

Cell & Gene Therapy Answers: Addressing Complex Analytical Needs with ddPCR/qPCR

Your source for answers to the complex challenges of cell and gene therapy development.

Decentralized Clinical Trials (DCT) Monthly Blog – October 2021

This month in the blog, we are going to look at how new options within the U.S. for handling investigator oversight of clinical trials.