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Company description

S-CLINICA is a Belgium-headquartered clinical trial technology company founded and owned by clinical trial experts, biostatisticians, and mathematicians, with over 27 years of industry expertise. The company specializes in Supply Forecasting and RTSM (Randomization and Trial Supply Management) solutions, serving sponsors across more than 119 studies from Phase I to IV. S-CLINICA is recognized as a pioneer and leader in the predictive probability-based, real-time-adjusted approach to clinical supply management, and counts top 10 pharma and biotech companies among its returning clients.

The S-CLINICA platform operates on a single backend database, enabling sponsors to optimize and implement supply strategies within one unified solution. This integrated approach helps eliminate drug wastage, prevent unplanned supply costs, and reduce overall expenditure by over 60%. The platform is designed to be 100% flexible, fast to set up, and supported by a proactive team, making it suitable for clinical trials of any complexity.

Supply Forecasting

• Supports the full study lifecycle, from the earliest planning stages through to End of Study activities, starting with minimal information available.
• Allows sponsors to investigate and compare possible supply scenarios against study objectives and verify the feasibility of recruitment targets and their impact on drug supply.
• Enables control of supply management, costs, and risks at every step of the trial.
• Powered by a comprehensive algorithm incorporating Monte Carlo simulation, Bayesian methods, and data from studies within the same program for highly accurate supply forecasting.
• Predictive probabilistic algorithm is adjusted to real-time data, representing the most advanced and comprehensive supply management algorithm in the industry.

RTSM (Interactive Response Technology)

• Offers a powerful, fully flexible IRT solution proven over 20 years across clinical trials of any complexity.
• Highly configurable with very short setup times, making it accessible and efficient for study teams.
• Features powerful cohort management and dose escalation management capabilities.
• New cohorts can be introduced without requiring protocol amendments, providing significant operational flexibility.
• Capable of handling any complexity of randomization to meet the demands of today's complex study requirements.

Drug and Supplies Management

• Manages all types of supply products — including investigational products, devices, and auxiliaries — throughout the entire supply chain, from production through central and local depots, to sites, pharmacies, and patients.
• Uses an advanced probability-based algorithm to predict and act on real-time data, harmonized with the supply forecasting module to minimize risks and waste.
• Supports bar code and QR code tracking for granular visibility of even the smallest supply units.
• Includes Direct-to-Patient (DtP) supply capabilities.

Production Planning

• Provides optimized suggestions for upcoming supply needs based on planned study supply strategies versus real-time data.
• Allows sponsors to create their own production schedules and supply chain plans within the system.
• Enables preparation of distribution plans and shipment schedules.
• Offers a global view across all studies for comprehensive oversight.

Direct-to-Patient (DtP) Drug Supply

• Designed to address the growing complexity of clinical trials for rare and orphan indications, personalized medicine, and oncology, where adaptive trial designs and diverse patient populations create unique operational challenges.
• Enables sponsors to manage the vast amounts of patient and trial data generated in operationally complex studies.
• Provides a flexible solution to meet the special needs of sponsors in every state and situation throughout the trial.

Supplies Return and Destruction Management

• Ensures complete transparency across the entire clinical supply chain for all stakeholders.
• Provides full accountability of drugs from initial production through to final disposal or destruction.
• Advanced drug tracking 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.
• Tracks dispensation to participants as well as the return of used and unused supplies.

Specialized Capabilities and Notable Details

• S-CLINICA is one of the few — and most developed — platforms to support explicit chain of command and chain of custody requirements for supply management in personalized treatments, including Cell and Gene therapy trials and RadioPharmaceutical trials.
• The platform supports IRT in veterinary studies, extending its applicability beyond traditional human clinical trials.
• Key outcomes delivered include eliminated waste, reduced overage, anticipated risk, fast setup, full flexibility, and proactive support.
• Operates across 119 countries and has supported studies spanning Phase I through Phase IV.

With nearly three decades of expertise and a uniquely integrated platform combining supply forecasting and RTSM on a single database, S-CLINICA delivers one of the most advanced and cost-effective clinical supply management solutions available to the life sciences industry today.

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Software attributed to S-Clinica

• Clinical Supply Forecasting & Production PlanningView
• RTSMView
• Personalized Medicine (Cell & Gene Therapy)View
• Direct-to-Patient Drug Supply ManagementView
• Supplies Return & Destruction ManagementView
• IRT in Veterinary Clinical TrialsView

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