Phase 1 Studies
At 3S Pharma, Phase I clinical studies represent a cornerstone of our full-service research offering, enabling early-stage process development through precision, safety and regulatory excellence.
Conducted in our purpose-built Clinical Research Units (CRUs) in Romania and Moldova, our Phase I phases are designed to meet the highest international standards and are fully compliant with ICH-GCP, FDA, EMA and local regulatory requirements.
Our Phase 1 Clinical Studies leading studies include:
- First in Human (SAD / MAD)
- Bioequivalence / Bioavailability
- Drug-drug interactions
- Food Effect
- Age & Gender
We also perform other types of studies, such as Hepatic Impairment, Renal Impairment, Proof of Concept, Pilot Studies, Human Factor Studies, PK / PD Studies
Specialized Facilities and Infrastructure:
Our CRUs are equipped to manage the full spectrum of Phase I protocols, from single and multiple ascending dose (SAD/MAD) studies to food-effect, drug-drug interaction, and first-in-human (FIH) trials.
Each unit features:
- Continuous cardiac telemetry and vital sign monitoring
- Crash carts and ICU-grade emergency response capabilities
- Real-time electronic data capture (EDC) systems
- On-site physician supervision and 24/7 trained medical staff and auxiliary personnel
- Dedicated PK/PD laboratories for sample collection and immediate processing
This infrastructure allows us to ensure subject safety while delivering robust and reproducible early-phase data.
Healthy volunteers and personalized patient selection
3S Pharma has extensive experience conducting studies in both healthy volunteers and special patient cohorts (based upon selection criteria in the study audit).
Our recruitment teams maintain active databases and relationships with referring clinicians, enabling rapid enrollment and protocol adherence even in complex or niche populations.
Comprehensive support services
- We offer end-to-end operational and scientific support throughout the study lifecycle:
- Study design consultation and protocol development
- Regulatory submissions and ethics approvals
- Bioanalytical method development through our in-house certified laboratory
- Pharmacokinetic/pharmacodynamic (PK/PD) data management and statistical analysis
- Medical writing and clinical study reporting (CSR)
Regulatory recognition and quality assurance
Our Phase I operations have undergone successful inspections by international agencies including the U.S. FDA, French ANSM, Dutch CCMO, and German BfArM, among others. These inspections confirm 3S Pharma’s commitment to quality, transparency, and compliance.
Why choose 3S Pharma for your company Phase I studies?
25+ years of operational experience in clinical pharmacology
1,000+ registered studies completed worldwide
Multidisciplinary scientific leadership and cross-functional project teams, with over 50% of the personnel with medical degree
Flexible timelines and cost-effective solutions without compromising quality and outcomes
In search of a trusted partner for Phase I clinical study?
Our custom made system ensures accelerated timelines, cost efficiency, regulatory compliance and scientific integrity, setting the foundation for success in every clinical study.
First-In-Human (FIH) studies at 3S Pharma
Part of the Phase 1 clinical study, the First-in-Human clinical trial starts after testing a new medicine in the laboratory and on animals. Done on a small cohort of individuals, the FIH study focuses on safety and tolerability of the drug in humans.
At 3S Pharma, FIH means first in reliability, first in compliance, and first in safety.
Proven bioequivalence & bioavailability expertise
In our tailored studies for Bioequivalence & Bioavailability in clinical trials, we focus on drug performance (in vivo), drug absorption, drug availability on site, being an important clinical study stage for predicting clinical outcomes.
