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 …
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 …
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 …
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 …
Welcome to the April edition of our Decentralized Clinical Trials blog
Sometimes success isn’t about the pieces that you have at your disposal, but rather it comes from how these pieces connect to each other, transforming a process and leading to a better outcome.
Expanding clinical trial support in Europe, the Middle East and Africa with a new automated kit production line
As part of a global growth and expansion strategy, we’re announcing the spring opening of a new kit production line at our European Operations Center (EOC). Based in Mechelen, Belgium, the EOC is a multi-use facility that handles dry ice production and distribution for the EU, as well as study …
Decentralized Clinical Trials (DCT) Monthly Blog – February 2021
Most of our blogs focus on interesting things we hear from sponsors, new company developments, or interesting challenges we encounter as we partner with sponsors. This month, however, we want to take a look at it from the patient perspective. The changes of the past year have resulted in a …
GDPR: What is it and what does it mean for your clinical studies: Part I
This two-part blog serves to summarize the Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by our Medical Device and Diagnostic Solutions through a review of the …
ISO 14155 update: key risk management changes for medical device clinical investigations in 2019
The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year. According to the International Organization for Standards (ISO), the updated edition will focus on …
How a no-deal Brexit might affect medical device development: legal consequences and risk mitigation strategies
How could a no-deal Brexit affect my medical device lifecycle? Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario. The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical …