Overcoming challenges in the processes of characterization, assessment, and registration of your UVCB in Europe

The demand under European regulations for detailed environmental risk assessment of UCVBs is challenging both the industry and regulators alike. Read on to explore the challenges and possible ways of overcoming them.

Who is most at risk for mold allergies? New study uncovers prevalence of mold allergies in the US

A recent study analyzed allergy testing data to identify who faces the highest risk for mold allergies and which mold species are most often linked to allergic reactions.

Six Automated Clinical Alerts You Need to Increase Efficiency in your Clinical Trials

What is an automated clinical alert? Automated clinical alerts continuously monitor study data and send alerts and notifications to clinical trial project team members based on specific study, country, site or subject performance criteria to help boost clinical study monitoring and improve quality management.

Antibody Reagent Spotlight – Generating positive control antibodies for your Anti-Drug Antibody (ADA) assay

Biopharmaceuticals, including monoclonal antibodies, recombinant proteins, hormones, cytokines, growth factors, gene therapy products are a crucial class of therapeutic agents that have transformed the treatment of various diseases. As these complex molecules are introduced into patients, it is essential to monitor potential immunogenic responses. Biopharmaceuticals, including monoclonal antibodies, recombinant proteins, hormones, cytokines, growth factors, gene therapy products are a crucial class of therapeutic agents that have transformed the treatment of various diseases. As these complex molecules are introduced into patients, it is essential to monitor potential immunogenic responses. The potential immunogenicity of biological products results in the elicitation of anti-drug antibodies (ADA).  Anti-Drug Antibodies (ADAs) are immune responses generated against the therapeutic drug itself. The assessment of ADAs is a vital component of biopharmaceutical development. To ensure the reliability and sensitivity of ADA assays, positive control antibodies are generated as key reference materials.

Recognizing National Kidney Month by Breaking Down Barriers to Improve Clinical Trials for Glomerular Diseases

To raise awareness about kidney diseases during National Kidney Month, we’d like to focus on rare renal diseases and the importance of studying not only adults but the pediatric population as well. Several rare glomerular diseases1 can impact the kidney’s important cleansing function. Tiny clusters of looping blood vessels, called glomeruli, sit within each kidney’s approximately 1 million nephrons. Similar to other kidney diseases, glomerular diseases often progress silently and remain undetected until the disease becomes more advanced. Once diagnosed, treatment options have historically been limited, but recent clinical trials and drug approvals have been encouraging.

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.

Labcorp expanding bioanalytical service offering in the Asia-Pacific region with an integrated laboratory in Singapore

To meet the increased demand of pharmaceutical and biotechnology companies and drive continued growth, we are pleased to announce the expansion of its bioanalytical operations in Asia-Pacific. This new laboratory in Singapore will be co-located with its Central Laboratory Services.

Decentralized Clinical Trials (DCT) Monthly Blog – May 2021

This month in the DCT Blog, we are going to put the spotlight on several events coming up in the next few weeks.

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.