DCT Blog post

Understanding vendor management challenges in Decentralized Clinical Trials (DCT, aka Hybrid and Virtual Trials)

The purported benefits of decentralized clinical trials (DCT) include accelerated enrollment, reduced patient burden and improved retention rates, among other efficiencies. Incorporating virtual elements into the traditional trial model requires a clear vision for the technologies, platforms and other “site-less” elements that support these efforts; however, the potential challenges of …

Using acute respiratory disease syndrome (ARDS) in vivo models to screen for coronavirus inflammation treatment

Solutions to the current COVID-19 pandemic involve preventing coronavirus infection through vaccination and treating the severe clinical symptoms of the disease, including acute respiratory distress syndrome (ARDS). Establishing in vitro screening for potential treatments, though, can be challenging, due to the limited number of appropriate research models available, and the …

patient safety

The future of pharmacovigilance

Leveraging technology to transform patient safety The challenges of maintaining complex pharmacovigilance (PV) systems in a global, ever-evolving regulatory environment are increasing daily. With growing public awareness, social media connectivity and media scrutiny, pharmaceutical companies need to manage PV activities diligently. Cost-reduction pressures on one hand and the challenges of …

Expediting timelines and enhancing quality for central labs global study startup

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 …

Pills

Overcoming the unique drug safety and regulatory challenges faced by small and medium biopharma

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 …

drug safety

Pharmacovigilance: a focus on EU drug safety excellence

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 …

drug safety covid

Monitoring drug safety during COVID-19 – five key questions and answers

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:

microplastics

How to prepare for the upcoming REACH restrictions on microplastic usage in Europe under Annex XV

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 …