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Contenu archivé le 2024-05-07

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Objectif



The virtual Clinical Laboratory (VCL) concept, in which hospital laboratories participate, uses a conversion procedure to recalculate results to a uniform reference method with minimal increase of variance. This results in a consistent data set with uniform reference ranges and comparable values, enabling a "central laboratory output" by "local laboratory input". When hospital laboratories paricipate in a VCL, they are better equipped to participate in large European clinical trials with minimal disturbance of their routine testing services. Benefit can be taken from the high quality facilities at the investigator site, while continuity of patient care will be secured. the VCL-concept was implemented in The Netherlands in 1995 as an initiative of the Dutch Society for Clinical Chemistry (NVKC) and the Dutch Foundation for Quality Assessment of Clinical chemistry Laboratories (SKZL). Extension of this Dutch initiative within the European Union will be a prerequisite to have VCL to obtain a meaningful position amongst regular large Clinical Laboratory Organisations (CLO's). With sufficient presence in the major European countries, i.e. the UK, France and Germany, and with a network with the sponsors in the Trans-Atlantic markets, the VCL concept will be of additional value to the large multi-centre phase IIb and phase III projects. This proposal is meant to explore the possibilities for extension of the VCL-concept in Europe and to identify the suitable partners to act as a local VCL-organisation. Software has to be developed in order to collect laboratory data from the local hospital information-systems to the central VCL computer. With the VCL -concept hospital laboratoires and hospital physicians will have better chance to participate in large clinical trials and strengthen the position of Europe in the contract-research market for the pharmaceutical industry.
The virtual Clinical Laboratory (VCL) concept, in which hospital laboratories participate, uses a conversion procedure to recalculate results to a uniform reference method with minimal increase of variance. This results in a consistent data set with uniform reference ranges and comparable values, enabling a "central laboratory output" by "local laboratory input". When hospital laboratories paricipate in a VCL, they are better equipped to participate in large European clinical trials with minimal disturbance of their routine testing services. Benefit can be taken from the high quality facilities at the investigator site, while continuity of patient care will be secured. the VCL-concept was implemented in The Netherlands in 1995 as an initiative of the Dutch Society for Clinical Chemistry (NVKC) and the Dutch Foundation for Quality Assessment of Clinical chemistry Laboratories (SKZL). Extension of this Dutch initiative within the European Union will be a prerequisite to have VCL to obtain a meaningful position amongst regular large Clinical Laboratory Organisations (CLO's). With sufficient presence in the major European countries, i.e. the UK, France and Germany, and with a network with the sponsors in the Trans-Atlantic markets, the VCL concept will be of additional value to the large multi-centre phase IIb and phase III projects. This proposal is meant to explore the possibilities for extension of the VCL-concept in Europe and to identify the suitable partners to act as a local VCL-organisation. Software has to be developed in order to collect laboratory data from the local hospital information-systems to the central VCL computer. With the VCL -concept hospital laboratoires and hospital physicians will have better chance to participate in large clinical trials and strengthen the position of Europe in the contract-research market for the pharmaceutical industry.
The virtual Clinical Laboratory (VCL) concept, in which hospital laboratories participate, uses a conversion procedure to recalculate results to a uniform reference method with minimal increase of variance. This results in a consistent data set with uniform reference ranges and comparable values, enabling a "central laboratory output" by "local laboratory input". When hospital laboratories paricipate in a VCL, they are better equipped to participate in large European clinical trials with minimal disturbance of their routine testing services. Benefit can be taken from the high quality facilities at the investigator site, while continuity of patient care will be secured. the VCL-concept was implemented in The Netherlands in 1995 as an initiative of the Dutch Society for Clinical Chemistry (NVKC) and the Dutch Foundation for Quality Assessment of Clinical chemistry Laboratories (SKZL). Extension of this Dutch initiative within the European Union will be a prerequisite to have VCL to obtain a meaningful position amongst regular large Clinical Laboratory Organisations (CLO's). With sufficient presence in the major European countries, i.e. the UK, France and Germany, and with a network with the sponsors in the Trans-Atlantic markets, the VCL concept will be of additional value to the large multi-centre phase IIb and phase III projects. This proposal is meant to explore the possibilities for extension of the VCL-concept in Europe and to identify the suitable partners to act as a local VCL-organisation. Software has to be developed in order to collect laboratory data from the local hospital information-systems to the central VCL computer. With the VCL -concept hospital laboratoires and hospital physicians will have better chance to participate in large clinical trials and strengthen the position of Europe in the contract-research market for the pharmaceutical industry.

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EAW - Exploratory awards

Coordinateur

Covance Virtual Central Laboratory B.V.
Contribution de l’UE
Aucune donnée
Adresse
2A,Kwekerijweg
3700 AW Zeist
Pays-Bas

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