Expertise: Other 51 results

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Understanding the Elements of a Typical IND‑Enabling Package

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...

Consulting

Three Keys to Preparing Effective Pre-IND Meeting Questions

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...

Other

4 Reasons I am a Premier Research CRA

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...

Other

6 Reasons to be a Premier Research Clinical Lead

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...

Other

Our Commitment to Time Off to Recharge

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...