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Nueva solución de gestión de ensayos clínicos

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOGR20161207001
Publicado:
19/12/2016
Caducidad:
19/12/2017
Resumen:
Una pyme griega ha desarrollado una plataforma que ayuda a compañías farmacéuticas, fabricantes de dispositivos médicos y centros de investigación a automatizar todo el proceso de desarrollo clínico y transformar la forma en la que se recogen, analizan y gestionan los datos de los ensayos. Se trata de un sistema basado en la nube que satisface las necesidades de monitorización de ensayos clínicos gracias al uso de herramientas de última tecnología e interfaces de usuario vanguardistas para todo tipo de ensayos. La empresa busca clientes en los sectores de sanidad y biotecnología con el fin de establecer acuerdos de servicio.

Details

Tittle:
Innovative clinical trials management solution
Summary:
A Greek SME has developed an innovative platform that support and enable pharmaceutical, medical device companies and research organisations to automate their entire clinical development process and transform the way clinical trial data is collected, analyzed and managed. The company is offering its services in the form of services agreement to clients from the healthcare and the biotechnology sector.
Description:
The Greek SME has built an innovative cloud based system for serving the needs of clinical trials monitoring based on the latest technology tools and state of art user interface for supporting all types of trials. This innovative clinical trials management solution (CTMS) is composed of several feautures for streamlining trial monitoring and data entry with electronic data capture (e-CRF), automated edit checks and queries resolution, patient and site reporting, real time notifications and reminders that are accessible from all trial participants according to their roles. The system is quickly adopted by investigators and ensures clinical trial monitoring and control are optimized.

The system developed by the Greek SME is a proven CTMS used in several clinical studies, programs and registries in all clinical phases across the pharmaceutical and biotechnology sector, and medical devices testing. Its flexible pricing allows it to be used for all types of trials, even when budget is not considered sufficient to include an e-CRF system.

Key benefits include:

· High user friendliness and usability: 95% of investigators are satisfied.
· Affordable alternative to paper case report forms: it reduces the average trial cost by 30% compared with a trial using paper case report forms.
· Lower trial monitoring costs: it lowers the monitoring cost by 20% when designing trials with risk based monitoring.
· Keeping study under tight control: Schedules, milestones, key risk indicators and mobile notifications in the novel system ensure that the study management is 25% more efficient when compared to other clinical monitoring systems.

The novel cloud base system has passed full system validation in accordance with international regulations and complies to 21 Code of Federal Regulations (CFR) part 11 and Health Insurance Portability and Accountability Act (HIPAA) requirements. The system is also offered as a service platform without need for initial investment.

The innovative system has been quite successful so far and the SME is currently seeking to expand its clientelle. They are interested to cooperate with actors in the fields of healthcare and biotechnology via services agreements.



Advantages and Innovations:

The novel clinical trials management solution platform has been built with latest technological tools offering unique advantages like auto-save and auto-validate functionality minimizing the resources needed for data management and related operations. The easiness of use along with the compliance with regulatory and clinical research requirements make it one of the most enjoyable electronic data capture system to be used in large scale operations saving time and money (over 30% than traditional paper based operation). Personalized notifications and reports with risk based monitoring principles have been also introduced to save more from monitoring and project management costs of any clinical study.

Stage of Development:
Already on the market
IPs:
Secret Know-how,Trade Marks,Copyright

Partner sought

Type and Role of Partner Sought:
The company is willing to collaborate with pharmaceutical and biotechnology companies, medical devices and diagnostics companies, academic institutions, medical centers, contract research organizations and other entities. The company is offering its cloud based clinical development solutions and tailor made services in order to cover specialized needs of partners via services agreement.

Client

Type and Size of Client:
Industry SME <= 10
Already Engaged in Trans-National Cooperation:
No
Languages Spoken:
English
Greek

Keywords

Technology Keywords:
06001001 Bioestadística, epidemiología
06002007 Ensayos in vitro, experimentos
06001002 Investigaciones clínicas, ensayos
06001012 Investigaciones médicas