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.
This complexity in design and the volume of data can only be securely and accurately managed through automation and technology, using specialist clinical trial software, including Interactive Response Technology and Drugs supply management tools.
At S-CLINICA we have been developing sophisticated IRT systems and Drug supply management tools used by innovative pharma and biotech clients for over the 23 years. Our focus on these core service offerings has enabled us to develop deep domain expertise in patient and drug supply management, helping clients avoid potential pitfalls.
Clinical trials are becoming more patient centric, with increasing use of virtual and hybrid trials, electronic patient reported outcome (ePRO) data collection through patients own devices, resulting in more requests for studies with direct-to-patient drug shipping for patients who aren’t able to leave home to attend clinical sites, or just to reach more, and increasingly diverse patient population who cannot or will not travel. In today’s COVID environment, with some patients unable to access hospitals and clinics or even reluctant to use public transport, patients centricity means been able to supply Investigational medicinal products (IMPs) directly to a patients home, with trial medication despatched from the clinical site, from a dedicated depot or in some countries from Pharmacies ( e.g., Denmark). In addition the technology underpinning this must also be sophisticated enough to be able perform the following tasks;
The S-CLINICA platform includes a supply forecasting module (ClinVision), which can forecast demand in supplies in a mix of traditional, site to patient shipments and or direct to patients (DtP) shipments.
Once a study is live, S-CLINICA’s IRT platform can manage patient interactions and drug supplies and perform a range of functions for sponsors, drug depots and clinical sites. Our IRT system offers much greater visibility to drug stock levels, often integrating to a warehouse return systems.
S-CLINICA ‘s IRT and drugs supply solution is able to anticipate a trial’s supply needs, keep trial data clean, and accommodates complex study designs.
In these challenging times, you need a trusted partner to ensure the success of your clinical trial. Come and speak to S-CLINICA.