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.

Expanded crop protection and chemical testing: For those committed to our planet’s sustainability and the welfare of humanity

We’ve been ramping up our product testing support at some of our European sites over the past few years to meet the needs of the rapidly growing crop protection and chemical industry. Now, we’re excited to announce a multimillion-dollar expansion at our Greenfield, Indiana campus in the U.S. that enhances your options even further to access more crop protection and chemical toxicology studies at a global scale.

Enhancing the Investigator Site Experience with Electronic Query Notification and Resolution (eQuery)

Investigator sites provide an essential connection between drug development sponsors and patients in clinical trials—and play a key role in producing high-quality data. To better support a site’s day-to-day study activities and make a difference for patient care, Labcorp Central Laboratory Services (CLS) is continually evaluating current practices and implementing ongoing process improvements.

Anti-Drug Antibody (ADA) positive controls generation against oligonucleotide therapeutics: Anti-Oligonucleotide antibody case study

Oligonucleotide therapeutics are generally single-stranded synthetic oligonucleotides with modifications in their structure to improve stability and PK properties. These therapeutics generally target RNA transcripts and reduce or modify the corresponding protein expression. Unlike most typical biologic drug classes such as monoclonal antibodies, the oligonucleotides are relatively small in size and contain fewer potential epitopes. In addition, the oligonucleotide therapeutics are delivered to immune restricted sites to remain locally confined.