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 global study startup

For drug development sponsors running global studies, each day counts on the path to market. To help support sponsors with a faster study startup, Covance Central Laboratory Services (CLS) has enhanced its core systems and technologies to significantly trim typical startup timelines, reduce the time to implement potential study modifications …

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 …

COVID

The COVID-19 road to recovery: coordinating clinical trial testing and central lab solutions

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, …