First-in-man studies (FIM) are our primary focus. On yearly basis we conduct a number of SAD and MAD studies sponsored by European and US biotech companies of any size. We are experienced in leading the way in first human trials. This includes everything from starting the process to reporting the final study results.
Our group of clinical pharmacology experts have the right experience on designing studies that are crucial for submitting New Drug Applications (NDAs). Our journey starts by getting approval from the European regulatory authorities for each study we contract.
Our purpose-built Phase I-unit facility ensures strict patient oversight, essential for conducting ascending dose studies safely. Based on our internal procedures, we’re able to quickly identified/ screen and randomize clinical study participants for each clinical trials protocol.
We cover any healthy volunteers’ demographic factors like age, gender, and dietary effects. Convex investigational team are not only quick in the recruitment process but have impressive ability to keep participants involved in short or long studies until their completion.
Here is a list of our clinical research services we provide for First-In-Human (FIH) study:
Convex has years of experience in planning, executing, and documenting First-In-Man (FIM) clinical trials on small or large molecules, in variety of clinical study designs. We have the know-how, the dedicated clinical research unit, and all internal processes / clinical strategy to ensure top-notch results quickly and smoothly.