Clinical Research Studies
The clinical research studies performed in our local facilities are proven by over 100 audits conducted by customers and third parties, all with positive conclusions and stating GCP compliance. All inspections concluded with GCP compliance and data acceptance.
Our goal is to help companies to have an integrated clinical perspective on how their products perform in the real world. That is why, at 3S Pharma we focus on conducting all the clinical testing services in an accurate, professional and time efficient framework for all parties.
We tailor end-to-end solutions that deliver accurate results, by optimizing every step of the clinical trial project, from study design to digital data management, enhancing communication and collaboration for companies and for engaged patients safety.
Our multidisciplinary expertise spans diverse therapeutic domains and treatment platforms, through our innovative and unique study approach, engaging the right population selection, integrating digital solutions and machine learning, and always offering the highest standards of quality and safety.
At 3S Pharma, we conduct cliical studies phases 1 to 4, integrating the full range of clinical studies development, from initial first-in-human dose escalation studies to extended clinical trials.
Areas of expertise
3S Pharma demonstrates robust clinical research capabilities across a broad range of therapeutic disciplines, encompassing both early-phase and late-phase invetigational studies.
We have conducted clinical studies in key medical domains including internal medicine, neurology, psychiatry, dermatology, enocrinology, gastroenterology, rheumatology, cardiology, pulmonology, infectious diseases, urology and oncology.
Furthermore, the company supports vaccine development and first-in-human studies, with a strong focus on healthy volunteer trials, bioequivalence, and pharmacokinetic investigations.
This extensive therapeutic scope, combined with standardized methodologies and adherence to ICH-GCP protocols, enables 3S Pharma to support complex clinical development personalized studies across a variety of target populations and disease states.
Early Phase studies
The Early clinical studies conducted in Romania and Moldova have been inspected by numerous European Authorities including those from France, Germany, Austria, The Netherlands, Island and others. These studies focus on the drug efficacy on various healthy people and pathology diagnosed patients, determining safe dosage in drug usage and collecting relevant data for next clinical trials phases.
Phase 3
As our facilities support the simultaneous testing of hundreds of patients, we can perform Phase 3 clinical studies, focusing on the safety of the drug and the specific efficacy assets compared to standard.
As known, most Phase 3 clinical trials last longer and can be the last phase before approving a new medication, but they are randomized and blinded.
Phase 4
Phase 4 studies are ongoing studies that focus on identifying long-term effects, harmful effects of the medication, after regulatory approval, under real-life conditions. Also, in this stage, we aim to assess efficacy and optimize the usage of the medication in different patients with certain characteristics.
