S Clinica

Founded in 1997, S-CLINICA is a privately owned company headquartered in Belgium. Established by clinical trial experts, biostatisticians, and mathematicians, the company has over 27 years of industry expertise. The scientific background of its founders has ensured that S-CLINICA is driven by science rather than marketing, fostering a team passionate about integrated technologies. This dedication has resulted in the development of one of the most innovative and flexible technologies in the industry, coupled with strong expertise and experience. S-CLINICA is a leading provider in the Interactive Response Technology (IRT) and Randomization and Trial Supply Management (RTSM) industry, offering advanced anticipatory management for clinical supply forecasting and management. Their ClinVision system provides dynamic solutions for clinical trials, supporting over 950 trials in 116 countries. The company's supply management algorithm, featuring a predictive probabilistic approach adjusted to real-time data, is recognized as the industry's most advanced and comprehensive. Pioneering the predictive probability-based approach for supply management, S-CLINICA's platform integrates Supply Forecasting and RTSM within a single backend database. This integration allows sponsors to optimize and implement supply strategies within a unified solution, achieving over 60% cost savings by eliminating wastage and preventing unplanned supply costs. The RTSM system is highly configurable, with short setup times and robust cohort management, capable of handling complex randomization to meet today's intricate study requirements. Additionally, S-CLINICA offers solutions tailored to explicit chain of command and custody expectations for supply management in personalized treatments, such as cell and gene therapy trials and radiopharmaceutical trials. Recognizing that clinical supply is a critical component of the clinical trial planning process, S-CLINICA emphasizes the importance of a sound clinical supply strategy and prompt kit delivery for trial success. Supply deficiencies can halt ongoing trials, while product overstock can be exceedingly costly. Their tools are designed to be utilized from the initial stages of a study through to end-of-study activities, allowing users to start with minimal information, investigate and compare supply scenarios against study objectives, verify recruitment targets' feasibility, and control supply management, costs, and risks at each step. Employing a comprehensive approach that includes Monte Carlo and Bayesian methods, S-CLINICA's powerful algorithm ensures accurate supply forecasting. Their IRT system is uniquely powerful and 100% flexible, proven over the past 20 years as one of the best in its class, as evidenced by numerous returning clients among the top 10 pharma-biotech companies. The company manages all types of supply products throughout the entire supply chain, from production through depots and sites to patients, using an advanced probability-based algorithm to predict real-time data. This harmonized process of drug supply management with supply forecasting options ensures minimal risks and waste. S-CLINICA's solutions provide optimized suggestions for future supply needs based on planned study supply strategies versus real-time data, enabling the creation of production schedules and supply chain plans within the system. As the pharmaceutical industry increasingly develops treatments for rare and orphan indications and pioneers personalized medicine in areas such as oncology, S-CLINICA's Direct-to-Patient (DtP) solution enables sponsors to meet the special needs in their studies in every state and situation. The company ensures complete transparency across the entire clinical supply chain for all stakeholders. Their Drug Return and Destruction module offers full accountability of drugs, from initial production to final disposal or destruction, with an advanced drug tracking system that monitors even the smallest units at both sponsor and investigative sites, following the protocol. The return and destruction process is thoroughly documented and certified with special approvals. Additionally, S-CLINICA offers RTSM solutions for animal health clinical studies (veterinary clinical trials), fully compatible with the latest EU legislations and guidelines for good clinical practice (GCP) and good manufacturing practice (GMP). Their RTSM is applicable to both national and multinational studies in animals, from small pilot studies to confirmatory studies supporting veterinary products, offering prompt RTSM setup, management of complex study designs, and flexible change management.