In 2022, ICH Q14 officially introduced the enhanced approach1 in analytical development as an alternative path to the minimal approach, the benefits of which are worth exploring further. Analytical data is essential in demonstrating the safety and quality of pharmaceutical...
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We spoke with Clinical Research Associates (CRA) to hear what they especially enjoy about working at Premier Research. Here’s what we discovered. I am a true partner to my sites.As a Premier Research CRA, you are a true partner with...
Congratulations! You’ve taken on a new job at Premier Research. This is an exciting step in your career—but you may also be a little nervous. That’s understandable. As many as 1 in 3 people would avoid change if they could...
I recently had the opportunity to participate in the 2024 Drug Information Association (DIA) Regulatory Submissions, Information and Document Management (RSIDM) Forum held in North Bethesda, Maryland. In this blog post, I'll share my insights and key takeaways from the...
Adherence to cGMP regulations assures the identity, potency, purity and quality of biologics or advanced therapeutics and helps ensure adequate control of manufacturing operations. A primary way to demonstrate these attributes for a biologic product under development is through assays....
We spoke with some Clinical Leads to answer the question: “Why Premier Research?” Here’s what we heard. A Focus on Career Growth Premier Research often promotes from within. “Keep growing” is one of our Core Behaviors, so management proactively supports...
CE marking is mandatory for marketing medical devices and in vitro diagnostics (IVDs) in the European single market, comprising all European Union (EU) member states and European Economic Area (EEA) countries. With the introduction of the EU Medical Devices Regulation...
Premier Research exists for one reason: To transform life-changing ideas and breakthrough science into new medical treatments. We care about improving human health and that starts with the health and wellbeing of our own team members, not only by offering...
You found an exciting role at Premier Research and have scheduled an interview. Amazing! Now you need to make a good first impression. It’s natural to be a little nervous, but you are up to the challenge. These 9 tips...
The FDA's January 2020 guidance, Chemistry, Manufacturing and Control (CMC)[1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics. The analytical package, consisting of...