Phase I – First-in-Human, Focused on Safety

At SCIRENT, we support our Medtech and Biopharmaceutical clients in designing and executing early-phase cardiovascular trials with precision and care. Phase I studies typically involve a small group of healthy volunteers or stable patients to assess safety, tolerability, and pharmacokinetics. They are the first stage where a new drug or device is tested in humans. These trials primarily focus on safety, tolerability, and pharmacokinetics.

Conducted in a highly controlled environment, Phase I trials assess how the investigational product is absorbed, distributed, metabolized, and excreted. Dose-escalation protocols help determine the maximum tolerated dose while monitoring for adverse events and early signs of benefit.

Scientist analyzing a blood sample during early-phase clinical research.

Our experise:

We help you generate the early evidence needed to guide investment and development decisions with confidence.

Why Partner with SCIRENT?

We are a specialized cardiovascular CRO with a deep understanding of the regulatory, clinical, and operational landscape. Whether you’re developing a novel device, diagnostic, or drug – we bring the expertise, network, and flexibility you need at every stage of development.

 

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