First - In - Human Clinical Trials

Timely and accurate data regarding the safety and efficacy of drug is critical for success at every stage of drug discovery and development. SGS applies its experience, capabilities and the latest technology to deliver outstanding support for clinical projects.

SGS provides the largest EU facilities for conducting first-in-human (FIH) and Phase I clinical studies with healthy subjects.

Over the last 6 years SGS performed 500 trials, of which 33% were FIH trials.

SGS conducts simple and complex FIH studies such as:

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

This study design strategy provides a bundle of studies quickly approved by Health Authorities and Ethics Committees and thus quickly releasing critical data for decision making.

Case study
In a First In Human study, SGS’ services allow clients within one week, to do the dose review and make the decision to go to the next dosing level due to its combined services:

• Clinical safety assessments (after the first single dose administration)
• ECG results (after ECG measurement and analysis)
• PK data (after analytical dosing)