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 actually occurs in clinical practice. That’s where real-world evidence (RWE) can help pharmaceutical companies to inform development planning and also to demonstrate a product’s comparative effectiveness, safety and value from the viewpoints of various stakeholders, including regulators, payers, prescribers and patients.

This article discusses the role of RWE, the different information needs among stakeholders and potential solutions for meeting their evolving requirements.

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Meet Me in 5: Growing Responsibilities and Careers in Mechelen, Belgium

Our “Meet Me in 5” series covers 5 people, topics or questions to illustrate how our business nurtures exceptional people, provides an energizing purpose and enables extraordinary potential in its employees’ careers.

In this article, we spoke to Ilse Mathieu, Site Lead European Operations Center – Associate Director, EMEA Distribution, based in Mechelen, Belgium. She discussed how the Covance Mechelen site is ramping up to become a major kit production facility to supply clinical trial kits across Europe, the Middle East and Africa – and what this high-profile project means for career growth opportunities in Mechelen.

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New REACH Nanomaterial Requirements: What You Need to Do

The New EU Nanotechnology Regulation

On December 3, 2018, the European Commission (EC) adopted Regulation 2018/1881, amending the existing , amending the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, to directly address nanoparticles. The nanotechnology regulation applies to any substance that might be, or might contain, a nanomaterial (e.g., powder), whether or not it has been manufactured as a nanotechnology. Crucially the revised nanoparticle regulation applies to both new and registered substances and all dossiers will need to be updated with the necessary data.

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What You Need to Know About Neonicotinoids and The EU

Photo of a bee

Introduction

Neonicotinoids were developed to find safer, more effective alternatives to chlorinated hydrocarbons, organophosphates, carbamates, and pyrethroids, so, ironically, some neonicotinoids are now banned in the EU because of their toxicity to bees and other pollinators, as well as to a wider group of species.

The agricultural and environmental consequences of neonicotinoid use and the recent EU regulatory restriction have made neonicotinoids one of the most controversial areas of science and policy.

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Step Inside Mechelen: A Day in the Life of a Regional Study Coordinator’s Project Management Role

Elien is a Senior Regional Study Coordinator (RSC), which is an associate project manager role, housed in our growing Mechelen, Belgium office for Covance Central Laboratory Services (CLS). She shared a glimpse inside a typical day as a Regional Study Coordinator, a role that manages local laboratory operations within our global project management department.

8:30-9:30 | I start each day by going through my inbox and calendar and making my to-do list.

Because we are working with a global team, we receive many emails overnight. My first task of the day is to clean out emails from previous days and organize others by priority so only action items are left – that way I can easily view my top priorities. Then I review my calendar and prepare for meetings.

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Covance Shanghai Strengthens Safety Pharmacology Capabilities for In-House IND Packages to Serve Asia Clients

Covance Shanghai is pleased to announce an expansion of its general toxicology capabilities to include safety pharmacology studies, allowing our Asia-Pacific clients to more easily complete their IND requirements for CFDA regulations.

What are the new safety pharmacology offerings?

The general tox team in Shanghai is now capable of running cardiovascular safety studies with dogs, using DSI PhysioTel Digital L11 telemeters to monitor drug elicited effects on electrocardiograms and hemodynamic parameters, heart rate and blood pressure. They are also able to run neurological and respiratory studies in rat models.

Team members from Shanghai were trained in these experimental procedures by experienced safety pharm specialists from the Covance Madison site. After several months of personnel training, beginning in June 2018, validation studies at the Shanghai site were completed in early  2019.

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#CovancePotential: A DREAMer’s Journey to Improve Health and Lives

Earning doctorate degrees in veterinary medicine and veterinary pathology are significant accomplishments, but they are underscored by the seemingly insurmountable challenges Dr. Alejandro Larios Mora has faced in his journey to date.

Alejandro wasn’t the student anyone pegged to be a doctor. In fact, he failed kindergarten – and by fifth grade the self-proclaimed troublemaker was only allowed to attend class with a parent escort.

“As a child, it’s very difficult to see past your surroundings if you live in a bad area. You think that’s as good as it gets,” Alejandro said. “That’s why it is important to have mentors – to show you something different, something better.” 

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From PhD to Clinical Trials Project Management: Ana’s Career Shift Quickly Delivers Results

Ana’s passion for biomedical sciences brought her to Covance as a Regional Study Coordinator (RSC) earlier this year. She said after working in R&D and chemistry, shifting to a project management role presented an opportunity to develop different skills and realize an immediate impact on patients’ lives. The opportunity to transform healthcare and change lives around the world – what we call Energizing Purpose – is the common thread that unites Covance employees like Ana to push new boundaries.

As she establishes her career in technical project management at our Central Laboratory Services (CLS) site in Mechelen, Belgium, Ana maintains a personal and professional balance with time at home and in the office. She has completed a rigorous training program and continues to develop her project management skills with her mentor.

Find out more about Ana’s role in project management and the potential she sees with a career at Covance.

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