First in Human

Translating molecules into clinical reality

For us, First-In-Human (FIH) studies represent a critical entry point into clinical development. These studies require not only scientific rigor but also advanced safety infrastructure and regulatory compliance.

With over 25 years of experience and a proven track record of successfully completed FIH programs, 3S Pharma provides a robust platform for the initiation of first-in-human clinical studies. Our team of well trained specialists offer tailored support throughout the FIH study process, from study design to implementation to clinical study report.

Our capacity, clinical precision, and integrated model make us a trusted partner for early-phase development, from molecule to human.

Why choose 3S Pharma for FIH trials?

  • 25+ years of experience in early-phase and FIH research
  • Advanced safety infrastructure for high-risk protocols
  • 160+ total beds across 3 facilities for scalable trial execution
  • Global regulatory recognition and full GCP compliance
  • Accelerated startup timelines and tailored operational models
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Purpose-built clinical facilities for early human exposure

Our dedicated Clinical Research Units (CRUs) in Romania and Moldova are fully equipped to manage the complexities of FIH trials. These facilities are designed to support both short-term and long-term confinement protocols with extended observation periods of up to 12 weeks. 

Total bed capacity includes:

  • 74 beds at our primary CRU in Cumpărătura, Suceava (Romania)
  • 50 beds and 36 beds at our two clinical units in Moldova

 

All our available units are equipped with:

  • On-site emergency response rooms with ICU-grade infrastructure
  • Continuous telemetry and real-time monitoring systems
  • 24/7 medical staff and on-call physicians
  • GMP-compliant clinical pharmacies for accurate IMP management
  • Controlled environments for dose escalation and adaptive protocol designs

 

This infrastructure ensures safety, comfort, and data integrity throughout all phases of subject participation.

Expertise in FIH study custom design and execution

Our expert multidisciplinary teams work closely to:

  • Translate preclinical data into safe starting doses
  • Develop and execute SAD/MAD protocols
  • Monitor pharmacokinetic/pharmacodynamic (PK/PD) data in real-time
  • Conduct adaptive dosing based on interim safety reviews
  • Manage serious adverse events with rapid-response procedures
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In-house bioanalytical & regulatory support

FIH studies benefit from seamless integration with our in-house bioanalytical laboratory, offering validated LC-MS/MS and immunoassay platforms. 

Combined with strong regulatory expertise, our team ensures swift approvals and full compliance with EMA, FDA, and ICH-GCP requirements. Multiple successful inspections by international agencies underscore our reliability and operational excellence.

If you are looking for a reliable, science approved CRO partner for your early stage product development, 3S Pharma would probably fit your expectations!

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More about FIH studies

This early stage in clinical trials is performed for the first on humans, after the drug overpasses the laboratory and animal testing. 

Using a small group of healthy subjects, FIH clinical studies focus on safety and tolerability, two essential characteristics for the next phases of the clinical trial to take place. 

Amongst the most important aspects regarding FIH studies design we mention:

  • starting dose selection – derive from the maximum recommended starting dose after animal testing, using the non adverse effect maximum dose taken drug
  • a dose acceleration schedule – sequential dosage helps identify and enhance reaction to unexpected adverse effects of the drug
  • clinical study duration – depending on the expected effects of the drug
  • administration path of drug – influence the effects of the drug
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VALIDATION AND ACCREDITATION

International certified expertise

3S Pharma is a full-service Contract Research Organization (CRO) with internationally recognized capabilities in clinical pharmacology and bioanalysis.

The company operates state-of-the-art clinical research units in Romania and Moldova, which have been successfully inspected by regulatory authorities such as the U.S. Food and Drug Administration (FDA), as well as national agencies from France (ANSM), The Netherlands (CCMO), Germany (BfArM), Austria (AGES), Denmark (DKMA), and Romania (ANMDMR), often under the coordination of the European Medicines Agency (EMA).
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These inspections confirm 3S Pharma’s full compliance with ICH-GCP guidelines and international regulatory requirements.

The organization’s extensive operational portfolio—comprising over 1,000 registered clinical trials globally—and its contribution to scientific literature further validate its role as a reliable and competent CRO partner for early-phase and late-phase development programs.

3 S Pharma ensures end-to-end solutions and support and continues to shape new approaches under international regulatory guidance.

Nevertheless, our researchers outstanding performance is also highlighted by a series of relevant publications in international peer reviewed journals and by the participation in public research projects in cooperation with other institutions (Universities, National Research Centers).
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