Early Phase Studies

Fast Track Approvals: Experience expedited regulatory approval in Moldova just 2 weeks from submission

These studies are essential for establishing a comprehensive understanding of a drug’s safety and efficacy profile before proceeding to later-stage clinical trials.

Early-phase clinical trials are a critical component in the development of new medical treatments, primarily focusing on evaluating safety, tolerability, and initial efficacy. These trials typically include Phase I and Phase II studies.

In addition to these phases, early development studies may include specialized assessments such as drug-drug interaction studies, pharmacokinetic evaluations in patients with different chronic diseases, gender-specific studies, and investigations into food or other. 

Phase I Clinical Studies Excellence at 3S Pharma

Phase I Clinical Studies aim to assess a drug’s safety profile in humans, determine how the body processes the drug (pharmacokinetics), and understand the drug’s effects on the body (pharmacodynamics).

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Phase 2 Clinical Studies Excellence at 3S Pharma

Phase 2 clinical study focuses on therapeutic efficacy and safety and is conducted on hundreds of participants, amongst whom there are patients diagnosed with the disease or condition that the drug is being developed to treat. 

In Phase 2 clinical study we also start to collect relevant data about the medication efficacy.

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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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