Virtual Monitor/Clinical Servant

VIRTUAL MONITOR 

Virtual Monitor is a software solution aimed at automating clinical trials’ monitoring. It plans to replace the clinical trial Monitors’ physical visits at hospitals, thereby reducing costs on the Pharma and CRO side, as well as automating the data recording.

Origin

The idea behind the project was first formulated by Adam Kruszewski, an experienced Contract Research Organisation executive. After serving as a long-term CEO of KCR, an international CRO, he developed very good understanding of the processes, costs and innefficiencies in the clinical trial industry. His expertiese allows us to pinpoint currently existing bottlenecks and build software focused on solving well defined problems.

He is supported by Łukasz Olek, an inventor, manager and investor with extensive experience in IT sector. Througout his career he founded, developed and exited various business ventures, including first online currency exchange platform in Poland walutomat.pl. Łukasz is responsible for the technical aspects of the Virtual Monitor.

Current Process

The current system of conducting clinical research is outdated as it utilises three different systems:

• Clinical Research Form solely for the clinical research, 
• Health Medical Record – hospitals’ own system
• Verification system

Those systems have a significant overlap when it comes to patients’ data collected, and involves many redundancies in data writing which is done manually. 

The system requires on-site visits by Clinical Research Associates in order to verify and cross-examine the data from CRF and HMR.

Data is reported using templates which differ from hospital to hospital as they are developed by respective staff.

Our innovation

• CRF and HMR systems’ communication – automated patients’ record rewriting through local server access
• Virtual Monitor can be accessed remotely so it eliminates most of the visits of Clinical Research Associates.
• Multilingual appointment templates which can be applied to an entire clinical reserach.

Clients for our solution are Contract Research Organisations which conduct clinical trials.

The global market of CROs is worth 39.6bn USD and average 12x EBITDA

Our solution can reduce the CRO costs thereby increasing EBITDA by 10% (Expert knowledge AK)

• Therefore, assuming the cost of the system at  ¼ of savings caused by it, the global market for our solution is rougly 760m USD
• Central and Eastern Europe market is roughly 15% of the global market
• As CEE is Orphinic Scientific’s (strategic investor of the project) CRO focus, this market is a viable option for initial distribution and sales
• Based on the aforementioned, Virtual Monitor CEE market size at 30% penetration is 34.2m USD

CLINICAL SERVANT

Overview

This project aims to develop and commercialise an innovative product - the CLINICAL SERVANT (CS).  The system will revolutionise the way medical substances are circulated during clinical trials. The new system will have a hardware layer in the form of SCCT® device (Smart Container for Clinical Trials), which is an intelligent container for clinical trials, and a software layer enabling monitoring and analysis of the flow of medical substances in many research centers simultaneously in real time. 

Description of product innovation

The concept of creating a new product has been based on a real existing market problem, identified based on numerous discussions with pharmaceutical companies and CROs (Contract Research Organization). The use of CS will create a unique value proposition in the clinical research industry. 

The solution planned for development will solve the current lack of advanced systems for monitoring the circulation of medical substances during clinical trials. The problem, in particular, is the inability to gather real-time information from multiple research sites on the number of substances present at a given research site, when substances were dispensed, and the quality of their storage conditions. The above information are critical and affects the safety and reliability of research processes, as well as their costs. 

In the current state of technology, there are no solutions to comprehensively monitor this data in real time through an appropriate hardware layer and dedicated software. The acquisition of the necessary information is manual. Clinical Research Assiciates (CRAs) collect the necessary information through physical visits to individual trial centers. At no point in time does a study monitor have reliable information on the amount of medical substances present in all centers at the same time. Monitoring of medical substances in the clinical trial process, although very important, is therefore currently an inaccurate and expensive process. It requires numerous physical visits by study monitors to sites, and the information obtained is only ex-post.