Covance Blog
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, …
As clinical trials worldwide are facing unprecedented challenges with the COVID-19 pandemic, the experts working at the regulatory bodies and pharmaceutical companies and staff working at contract research organizations (CRO), such as Covance, have a focus to maintain patient safety as a top priority. Almost overnight we saw many hospitals …
As part of an ongoing effort to improve efficiencies and increase patient centricity, long-term follow up (LTFU) studies are increasingly using decentralized clinical trial (DCT) models and reducing the need for patients to visit physical investigator sites. While the prospects of cutting study costs and reducing patient burden are attractive, …
