Covance Blog
For drug development sponsors running global studies, each day on the path to market is precious. To help support sponsors’ accelerated study startup, Covance Central Laboratory Services (CLS) has enhanced its core systems and technologies to significantly trim typical startup timelines up to four weeks, reduce the time to implement …
Chimeric Antigen Receptor T Cells, In Vitro and In Vivo Preclinical Models, plus regulatory and safety considerations In a recent webinar, we presented on and discussed the adoptive cell therapy preclinical program central to an IND/IMPD submission. The following is a brief summary, plus insightful Q&As from that event.
Leveraging an Integrated, Holistic Solution Small- and medium-sized enterprises typically do not have the resources and expertise to establish an internal pharmacovigilance (PV) operation, as this would divert valuable time and money from product development. As a result, clinical development or regulatory groups, which are not specialized in PV, often …
Technology is front and center of patient support programs today, but it isn’t a silver bullet. We need to balance technology with people and processes to achieve the right equilibrium of efficiency and risk.
A compelling model for small and medium-sized organizations in the current EU regulatory landscape Regulatory dynamics in the EU continue to evolve, with higher expectations for pharmacovigilance (PV) as each nation has rigorous and complex patient safety regulations. The shifting landscape represents a unique challenge for small- and medium-sized enterprises …
Creating groundbreaking medicines and therapies and providing world-class diagnostics isn’t easy. But every day, employees at LabCorp, the parent company of Covance, are improving the health and lives of patients around the world. We recently had a virtual chat with Anna, a recruitment coordinator in our department of global talent …
Identifying, recording, and reporting adverse events is vital for ensuring drug safety, both in the pre-marketing and post-marketing settings. Today, the COVID-19 pandemic makes these activities both more critical and more challenging. Let’s consider five key safety questions and answers:
Intentionally added microplastics (tiny solid polymer particles) are included in various chemical products. Like degraded microplastic waste, intentionally added microplastics are of concern because of their potential to impact human and animal health. Regulators worldwide are assessing how to address intentionally added microplastics, with the ECHA classifying them as equivalent …
In January 2020 the Food and Drug Administration (FDA) reviewed its 2017 draft content and published finalized guidance for in vitro and clinical drug interaction studies. We’ve summarized the the key changes and implications for in vitro drug-drug interactions (DDI) testing in this post, but if you would like more …
As COVID-19 was declared a pandemic, Covance Clinical Trials Testing Solutions (CTTS) witnessed a sudden influx of COVID-19 studies from both large pharmaceutical organizations and biotechs. Not only did CTTS need to accelerate the timelines for these drug development sponsors’ urgent studies, but they needed to provide patient-centric testing solutions, …
