covid-19 covance labcorp diagnostics drug development

Covance and LabCorp Deliver Unmatched COVID-19 Diagnostic and Therapeutic Applications

We’re in this together: How Covance and LabCorp are delivering unmatched acceleration of COVID-19 diagnostic and therapeutic applications Accelerating much needed COVID-19 testing, vaccines and treatment options across the world can’t be done alone. We’re in this together and ready to apply our unique combination of solutions that blend Covance …

RA Biosimilar Recruitment

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs.

Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …

Closing the Knowledge Gap with Real-World Evidence (RWE) Studies: The Importance of Starting Early

Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what …

RA Biosimilar Recruitment

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs.

Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …

Customizing Real-World Evidence (RWE) Study Designs: A New Framework Tool That Incorporates Elements of Virtual Study Design

While assisting clients with their clinical development plans, and post-marketing studies, our team is witnessing a trend in designing RWE studies with both traditional and virtual elements. With growing interest in hybrid designs, Covance is exploring how we can help our clients incorporate their study objectives while evaluating a range …

Futuristic Hexagons

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 …