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First-In-Human (FIH) Clinical Trials

Timely and accurate data regarding the safety and efficacy of a drug is critical to your success at every stage of drug discovery and development. By working with our Clinical Pharmacology Unit, you will benefit from our experience, capabilities and the latest technology to deliver outstanding support for clinical projects.

We provide you with the largest EU facilities for conducting first-in-human clinical trials (FIH) and Phase I clinical studies with healthy volunteers. In the last six years, we have been trusted by major global organizations to perform 500 trials, of which a third were FIH clinical trials.

We conduct both simple and complex FIH studies such as:

  • Single Ascending Dose trials (SAD) and Multiple Ascending Dose trials (MAD)
  • Combined protocols: SAD + MAD + food + Proof of Concept (POC)

Our combined protocols study design strategy provides a bundle of studies quickly approved by health authorities and ethics committees. That means you will rapidly get critical decision-making data from your FIH studies.

Case study

In a first-in-human study, our services enabled our client to carry out the dose review, and make the decision to go to the next dosing level within one week, due to timely combination of:

  • Clinical safety assessments (after each dose administration)
  • ECG results (after ECG measurement and analysis)
  • Pharmacokinetic data (after bioanalytical assays)

Contact us today to learn how we can help with your early phase, first-in-human clinical trial program.

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Exploratory DevelopmentExploratory Development to Proof of Concept Integrated services reduce time to market (PDF 876KB) ...
Starting Dose SelectionFIH TrialsStarting Dose Selection in FIH TrialsDetermining starting dose through various methods (PDF 120KB) ...
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