AN INTEGRATED AUTOMATED ECG DIAGNOSTICS PLATFORM TO IMPROVE CARDIAC SAFETY IN CLINICAL DRUG TRIALS

The purpose of the CaSI phase 1 action was to assess the commercial and technical feasibility of a proposed new solution for cardiac safety in clinical drug trials. Cardiac safety in clinical trials is a mandatory requirement and the market has grown to be worth over €1Bn since its regulatory starting point in 2005. However it is beset by many problems, not least of which are considerable inefficiencies, unnecessary time delays and unsuitable equipment. CaSI is intended to overcome these problems, introduce significant cost savings for customers, improve the delivery of clinical trial data thereby benefiting patients and enhance Vitalographs growth.
Within phase 1 there were 24 individual actions in the market analysis and technical feasibility sections covering such items as regulatory, quantitative and qualitative analyses, planning, pricing and costing.
The market analysis resulted in strong confirmation of the opportunity as well as more concrete information on pricing and target customers. Of particular importance in the market section was the extremely successful engagement with KOLs who were incredibly supportive and enthusiastic about the idea as well as the relationships developed with two key lead customers who, again, were very positive about the proposed solution.
The technical feasibility was a comprehensive analysis of the concept including an in-depth literature review, IP review, risk and regulatory analyses, and detailed prototype bench work resulting in three detailed user requirement specifications (URS) for the main elements of the proposed solution. These URSs incorporate the lessons learned from Phase 1 in terms of technical, regulatory and market requirements. Detailed project plans were also completed as well as costing for the full development.
It was also established during Phase 1 that the quality of validation was vital and key relationships were established with expert third parties to conduct the independent validation. Access was also secured to vital resources and data needed to perform the validation. The Phase 1 action served to considerably strengthen the case for the project.
Lastly during Phase 1 an innovation capability analysis conducted by EEN was extremely useful in identifying areas for improvement within Vitalograph and an SME business coach is working with us on some processual improvements.

Objectives;
• Develop the full business, development and marketing plans for Phases 2
• Perform quantitative and qualitative market research & investigate pricing models
• Prepare Phase 2 Application & conduct Ethics review
• Conduct technical feasibility including prototyping and demonstrations
• Preliminary IP search & full clinical literature review
• Secure access to ECG database(s), primarily CSRC
• Search for and secure lead customers and KOLs, not part of the consortium

Work performed;
KOls have been identified and successfully engaged
Lead customer engaged
Market research completed
Technical feasibility completed
IP freedom to operate completed
Literature review completed
Access to CSRC and additional databases secured
Development plan completed
Business plan nearing completion

Main results achieved;
The product and concept is technically feasible and within Vitalographs capability
There is a large market need and desire for this concept
Access to validation databases has been secured
KOLs endorsement of concept and proposal
Accurate costing and pricing of final solution
Risk Analysis complete
Three specifications for the device, application software and web application are completed

The final result of the overall project will be a new integrated device for cardiac safety in clinical trials
that combines speed, accuracy and low cost.
This will be supported by software applications.

The Impact of the final product will be as follows

Vitalograph; increased revenue, margin and market share
Drug companies; reduced cost of drug trials, faster consistent, accurate data
CROs; Increased efficiencies and throughput, lower costs
Patients; safer drugs and lower costs, reduced time to market

Periodic Reporting for period 1 - CASI (AN INTEGRATED AUTOMATED ECG DIAGNOSTICS PLATFORM TO IMPROVE CARDIAC SAFETY IN CLINICAL DRUG TRIALS)

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