End-to-End Remote Site Monitoring and Clinical Trial Management Solution

Información del proyecto

Citrus

Identificador del acuerdo de subvención: 836256

DOI

10.3030/836256

Proyecto cerrado

Fecha de la firma de la CE 19 Noviembre 2018

Fecha de inicio 1 Diciembre 2018

Fecha de finalización 31 Marzo 2019

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

CRU HUNGARY EGESZSEGUGYI ES SZOLGALTATO KORLATOLT FELELOSSEGU TARSASAG
Hungary

Periodic Reporting for period 1 - Citrus ( End-to-End Remote Site Monitoring and Clinical Trial Management Solution)

Período documentado: 2018-12-01 hasta 2019-03-31

Resumen del contexto y de los objetivos generales del proyecto

Clinical trial costs have been constantly on the rise in the last years the total cost of a single big trial can reach €600 million. The increasing costs have significant implications for public health, as it affects pharmaceutical and biotech companies’ willingness to undertake clinical trials, which in turn limits patient access to novel treatments. To monitor clinical trials, it is a common practice to conduct site visits frequently and to verify source data during these visits. On-Site monitoring accounts for up to 14% of overall clinical study costs.
These costs can be reduced by making wider use of mobile technologies, centrally available data to evaluate site performance, electronic data capture, and other efficiency-improving options.
Existing systems on the market do not offer solutions to the problem. There are systems for clinical trial financial management; systems for electronic data capture; systems that provide access to electronic health records (EHR) and lab results (e-source) or access to mobile health devices. All these separate systems do not necessarily talk to each other, staff at clinical research sites report usage of three different systems to enter patient/study data.
Citrus - Clinical Trial Management & Remote Monitoring is the first revolutionary solution to offer remote monitoring capabilities. It is an end-to-end solution which includes CTMS, direct access to lab results and EHR, access to mHealth devices and it ensures data privacy compliance when data is accessed remotely.
Founded in 2008, CRU Hungary leads the clinical research services in Center-East Europe. Their 4 clinical research sites are preferred companies such as Pfizer, AstraZeneca and GSK. Our IT department have been developing solutions that answer to real pains in the clinical trial process and whose purchase is currently negotiated with T-Mobile and leading university hospitals in Hungary.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

To ensure the CITRUS technical feasibility, during the technical feasibility we have detailed our requirements and development plan for the different components of the CITRUS system: SOP development and system design for remote monitoring, e-source systems integration, 3rd party document authentication, Interface to common medical devices, Integration of QR/barcode scanner, Interface to scanner, multi-language support, Improvement of UI and functionality of multi-site management. We have reviewed data protection laws and proposed a solution for data anonymization. We have also defined a technical plan extended over 24 months and organized into 6 work packages and estimated the needs resources to develop the technical activities.
To ensure the CITRUS commercial feasibility, during the technical feasibility have identified the potential market for CITRUS, target customers, and competitors. We have designed our marketing strategy and identified 3rd party suppliers for document authentication and mHealth devices. The pricing strategy has been defined. CRU has built a dissemination and communication plan to raise the awareness amongst every potential customer, which includes the organization of workshops, attending tradeshows and an increased presence in specialized media. According to our preliminary IP assessment, we have freedom to operate and we have no plans to patent our CITRUS software solution.
To ensure the CITRUS financial feasibility, during the technical feasibility have analyzed and forecasted our overall costs related to the production, the commercialization of CITRUS, and built a 5-year financial forecast.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

CITRUS will be the only product that enables remote site-monitoring and is more competitively priced providing best value for money. Along with Interoperability and our extensive experience in the clinical trials field, those are our competitive advantages. Remote monitoring will enable smaller companies to conduct clinical trials, foster innovation in the field creating a new market.
CITRUS will have the following impact:
- Savings of up to 70% of on-site monitoring expenses.
- Remote site-monitoring – Monitoring protocol followed remotely as if on site. ALL data is monitored.
- Reduction of medication errors – with barcode system to automatic medication administration
- Interoperability – an end to end solution including CTMS, access to EHR, lab results and mHealth devices
- Coming from the field - we know what is necessary to deliver a successful clinical trial operation
- Flexible pricing model; SaaS model with no need for high initial investment can suit smaller research sites.
In addition, CITRUS will have the following social impact:
- Reduce the necessity for on-site monitoring which is one of the major contributors to the high cost of clinical trials facilitating the conduction of new clinical trials
- Ease the logistics of clinical trials, enabling more patients to take part and reducing the burden resulting from the ageing of EU population
- 100% data integrity leading to full clinical trials data transparency as stated in the EC Clinical Trials Directive
- Good practices can be assured by automatic data validation tools

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