As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. High-quality IND-enabling studies demonstrate that a drug is reasonably safe for use in humans and that it exhibits sufficient pharmacological activity to justify further development, ensuring the highest probability of transitioning…
Expertise: Other 50 results
When pitching to investors, a sponsor is not just selling them on the product; it is also promoting its ability to develop that product. Investors want to know the risks involved with the program, but they are also evaluating the sponsor as a risk factor of its own. Investing in emerging biopharma companies is a…
Asking the appropriate questions during a pre-IND meeting with the FDA is a critical step in planning a development program. A Pre-Investigational New Drug Application (pre-IND) meeting can be a valuable component in planning a development program. For companies that have not previously interacted with the FDA in the early stages of a product’s development,…
Culture Value: We Work Together In college I studied psychology, which involves a lot of statistics, and I noticed that I liked it and I was good at it. So, I went for a master’s degree in statistics, specifically for the pharmaceutical industry. I quickly understood that was the right path for me. I started…
We spoke with Clinical Research Associates (CRA) to hear what they especially enjoy about working at Premier Research. Here’s what we discovered. If you’re interested in becoming a CRA at Premier Research, search current openings.
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 and contemplating a whole new work setting—new people, new responsibilities, new processes—may only compound that…
We spoke with some Clinical Leads to answer the question: “Why Premier Research?” Here’s what we heard. Premier Research often promotes from within. “Keep growing” is one of our Core Behaviors, so management proactively supports career ambitions, making sure people gain the breadth of experiences they need to move into the next role. One key…
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 competitive healthcare benefits but insisting on true work-life balance. Supporting time off is a key…
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 based on our experience interviewing hundreds of candidates may help you prepare. Preparing for the…