Supply Forecasting – RTSM

About S-Clinica

S-Clinica is headquartered in Belgium. Founded, and owned by Clinical trial experts, Biostatisticians, and Mathematicians, S-Clinica has over 27 years of industry expertise. Its supply management algorithm, with its predictive probabilistic adjusted to real time algorithm, is the industry’s most advanced and comprehensive.

  • S-Clinica pioneered and are leaders of the predictive probability-based adjusted to real time approach for supply management.
  • The S-Clinica platform with the Supply Forecasting + RTSM, works on a single backend database, allowing sponsors to optimize and implement supply strategies within a single solution, and save over 60% in costs by eliminating wastage, and preventing unplanned supply costs.
  • S-Clinica RTSM is equally advanced, highly configurable (very short setup times) with powerful study team friendly cohort management, and can handle any complexity of randomisation, to cater to complex study requirements encountered today.
  • S-Clinica is one of few (or most developed) as a solution to cater to explicit chain of command / custody expectations for supply management in personalised treatments (Cell & Gene therapy trials/ RadioPharm trials)
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Enabling Direct-to-Patient (DtP) Drug Supply through Interactive Response Technology

The pharmaceutical industry is increasingly developing treatments for rare and orphan indications as well as pioneering personalised medicine in diseases such as oncology and has led to the use of sophisticated adaptive trial designs and a corresponding increase in the number of operationally complex clinical studies being conducted.  As trial designs evolve to meet the needs of these often unique, smaller and more diverse patient populations, one of the key challenges for trial sponsors is the management of the enormous amount of patient and trial data being generated as a result.

Supply Chain and Supply Management optimization

Say goodbye to drug wastage, anticipate risks and costs!
  • Clinical supply is a key component of clinical trials planning process. Good clinical supply strategy and quick kits’ delivery are both very fundamental for the success of the clinical trial. A supply deficiency can cause an ongoing clinical trial to stop, a product overstock can be extremely costly.

Use the tool from the 1st steps of the trial till closure
  • Start with minimum information available, enjoy user-friendly setup Investigate and compare possible supply scenarios against study objectives
  • Verify feasibility of recruitment targets and impact on study drug supply
  • Control supply management, costs and risks at each step

Powerful algorithm for accurate supply forecast
  • Comprehensive approach
  • Monte Carlo
  • Bayesian
  • Studies of the same program

Drug & Supplies Management​

A powerful solution to reduce the waste and risks
  • S-CLINICA manages all types of supply products throughout the entire supply chain from Production through depots and sites to Patients. S-CLINICA uses its advanced probability-based algorithm to predict real-time data. The process of drug supply management is harmonized with supply forecasting option which ensures minimal risks and waste.

Management of supplies throughout the supply chain
  • Any type of supplies: investigational products, devices, auxiliaries, etc
  • From Production – to Central and local depots – to Sites / Pharmacies – to Patients
  • Bar/QR-code
  • Direct to Patient

Pooled supplies management
  • The pooled supply studies require managing specific challenges. S-CLINICA applies our highly advanced probability-based algorithm adapted to real-time data prediction. It offers the most efficient supplies management for these kind of studies.

IRT: Powerful and fully flexible

Powerful and fully flexible. Years of expedited setup

  • S-CLINICA offers an incredibly unique, powerful, and yet 100% flexible IRT for clinical trials of any complexity. Our IRT has been proven as one of the best in its class over the last 20 years as evidenced by the many returning clients among top 10 Pharma-Biotech companies.

 

Advanced Setup / Expedite IRT support

  • Unique setup approach
  • Very short setup timelines
  • 100% flexible: study of any complexity


Powerful Cohort and Dose escalation management

  • Flexible cohort management
  • No amendment is needed to introduce new cohorts

IRT in Veterinary Clinical Trials​

S-CLINICA offers RTSM offering to Animal Health Clinical Studies (Veterinary Clinical Trials)

With the new Veterinary Medicines Regulation coming into force in 2022, S-CLINICA already has a solution for clinical trials for veterinary investigational medical product management. Our solution is fully compatible with latest EU legislations and guidelines for good clinical practice (GCP), and good manufacturing practice (GMP).The RTSM of S-CLINICA is applicable to both national and multinational studies in animals, from small pilot studies to confirmatory studies in support of a veterinary product. We offer prompt RTSM set-up, management of studies with complex design and flexible change management.

Supplies Return & Destruction​

Full visibility throughout supply chain
  • S-CLINICA makes the entire clinical supply chain transparent to all stakeholders. Our Drug Return and Destruction module provides the possibility to access the full accountability of drugs from its initial production to final disposal or destruction. Our advanced system of drug tracking enables us to follow even the smallest unit at both sponsor and investigative sites according to the protocol. The return & destruction process is fully documented and approved by special certificates.

Tracking of dispensing and/or return
  • Dispensation to patients
  • Return to site of used and unused product
  • User error management
  • Management of lost units
  • Tracking to the smallest unit