3S Pharma
Accelerating Global Healthcare Breakthroughs

For over 25 years, 3S Pharma has led the way in clinical research, transforming the development of life-changing therapies and ensuring faster, safer delivery to patients.

A global leader in clinical development and bio-analytical services, it combines unmatched speed, steadfast regulatory excellence and innovative methodologies. This synergy empowers clients to overcome drug development challenges, fostering breakthroughs that enhance patient care and set new benchmarks in global healthcare.

Acting as a fully integrated partner, it delivers a holistic approach to clinical research tailored to meet the distinct needs of each client. From crafting protocols and designing studies to managing regulatory submissions and producing final reports, it ensures flawless execution at every stage. Drawing on extensive expertise in clinical operations, safety analysis, data management and biostatistics, 3S Pharma empowers clients to confidently navigate the complexities of drug development.

“We’re truly customer-centered—listening, adapting and finding creative solutions to meet our clients' unique needs in the ever-evolving clinical research space,” says Simona Rizea Savu, managing director.

Combining advanced infrastructure with a client-centered philosophy, 3S Pharma specializes in early-phase clinical trials, pharmacokinetics studies, bioavailability and bioequivalence research, and transdermal patch evaluations. As one of the few European contract research organizations with integrated bio-analytical and clinical facilities, it distinguishes itself in a highly competitive field.

With a proven track record of over 1,500 studies conducted across five continents and more than 30 countries—including Germany, Italy, France, Greece, Canada, the U.S. and India—3S Pharma continues to expand its global footprint while maintaining high standards of quality and efficiency.

Infrastructure Excellence with Participant Safety at Its Core

3S Pharma’s state-of-the-art facilities are designed to ensure precision, scalability and efficiency in clinical research. The integrated bio-analytical laboratory utilizes advanced techniques such as HPLC-MS/MS for analyzing small and large molecules and ICP-MS for precise element determinations, including iron, zinc and strontium. Complementing this advanced laboratory is its purpose-built clinical site in Romania, featuring 74 beds organized into operational units capable of functioning independently or collaboratively. This setup allows for large-scale studies accommodating up to 300 participants, ensuring flexibility and efficiency in meeting diverse clinical trial needs.

Further enhancing its capabilities, the Moldova site offers a distinct advantage with an expedited regulatory approval process, enabling clearances in as little as two weeks. This capability supports rapid, high-quality outcomes for time-sensitive clinical studies while strictly adhering to the highest industry standards.

Regulatory excellence underpins every aspect of 3S Pharma’s operations. Over the past decade, it has undergone numerous inspections by European regulatory authorities, including those from France, Germany, Austria and the European Medicines Agency (EMA). The July 2024 EMA inspection reaffirmed the company’s adherence to Good Clinical Practice standards. Its bio-analytical laboratory has undergone multiple U.S. FDA inspections, with the latest in April 2023 concluded without any observations, reflecting its rigorous quality standards.

Central to all its endeavors is a commitment to participant safety. From study design to execution, this priority guides every decision, forming the ethical foundation for 3S Pharma’s effective clinical research practices.

Its recruitment strategies enable the swift enrollment of large groups, both healthy volunteers and patients receiving stable treatments, across regions such as Romania, Moldova, Georgia, Armenia and Bosnia. The extensive database of over 10,000 healthy volunteers enables rapid recruitment for clinical studies. Its ability to manage long-term confinement studies, ranging from four to eight weeks, with retention rates exceeding 90 percent, underscores its dedication to participant satisfaction and the integrity of its trials. This strength is further bolstered by its strong partnerships with hospitals across Eastern Europe, ensuring access to diverse patient groups.

“The safety of the subject is our top priority. Everything else comes after. Every decision we make, whether in study design, execution or management, is guided by this principle,” says Savu.

Tailored Clinical Trials for Accelerated Outcomes

3S Pharma has built a strong reputation for its specialization in early-phase clinical trials, focusing on critical areas that lay the foundation for successful drug development.

First-in-human studies, a cornerstone of its expertise, provide essential insights into a new drug’s safety and initial pharmacokinetics. These studies are complemented by further pharmacokinetic research, which delves into drug absorption, distribution, metabolism and excretion, offering a comprehensive understanding of their behavior within the body during early development. Bioavailability and bioequivalence studies play a crucial role in evaluating how a drug is absorbed and its therapeutic equivalence to existing treatments.

This deep expertise extends to studies for locally applied and locally acting products, including topical dermatologic corticosteroids. It has conducted innovative vasoconstrictor assays, ranging from pilot dose-duration response evaluations to pivotal bioequivalence studies based on pilot findings. The meticulous work ensures that products meet stringent regulatory requirements, setting the stage for subsequent clinical development.

3S Pharma is equally adept at managing Phase II, III and IV studies. These are conducted either in its cutting-edge clinical facility in Romania or through collaborations with hospitals across Romania and Moldova. For trials requiring specific patient populations, it has established partnerships with numerous healthcare providers, continuously expanding its network to meet diverse investigational needs. This collaborative and adaptive approach ensures thorough support for every clinical research phase.

Backed by a dedicated team of over 100 professionals, including medical doctors, pharmacists and biologists, 3S Pharma consistently pushes the boundaries of what is possible in clinical research.

Innovation Driving Clinical Execution

Innovation defines 3S Pharma’s approach to clinical execution. It adopts cutting-edge practices while adhering to regulations, continuously refining methodologies to enhance outcomes and deliver greater value to clients.

For example, in transdermal patch evaluations, it goes beyond standard visual inspections by incorporating thermal imaging technology to identify areas of secure adhesion and detachment. The detailed, objective approach ensures a more comprehensive understanding of patch performance. Thermal cameras are employed to assess local inflammation following injections, offering precise, data-driven evaluations of pain and discomfort caused by different devices. These methods represent a significant leap in study precision, improving the reliability and depth of trial results.

Technological advancements further elevate 3S Pharma’s capabilities. AI plays a critical role in risk assessments, identifying potential challenges with remarkable efficiency and accuracy. It has transformed traditionally labor-intensive processes, such as tablet crushing, by introducing a highly effective, automated solution. This innovation ensures greater consistency and accuracy in research, significantly improving the reliability of study outcomes.

AI also streamlines documentation processes, particularly in preparing study protocol summaries for regulatory submissions. Translating complex scientific language into clear, accessible formats, AI tools accelerate timelines and ensure compliance with EMA requirements.

With a legacy of innovation and excellence, 3S Pharma is a trusted partner for clinical research needs worldwide. Its focus on advancing global health through cutting-edge clinical research positions it as a pioneering force in the pursuit of safer and more effective therapies.