RABIOPRED project consists of 8 work packages (WP) as briefly described below:
WP-1: Analytical validation of gene signature
The main objective of the work package 1 is to perform the analytical validation of the RABIOPRED assay, in order to fulfill the ISO17025 accreditation. (i) Analytical validation of gene signature and (ii) determination of the reference range in a healthy volunteer study are among the tasks of this work package.
WP-2: Preparation of briefing book & European Medicines Agency consultancy
WP2 shall obtain scientific advice from the European Medicines Agency (EMA), in order to design a clinical trial that will provide data to meet all regulatory requirements to obtain CE marking in WP5.
The EMA qualification process is a new, voluntary, scientific pathway leading to either a CHMP opinion or a scientific advice of novel methodologies on innovative methods or drug development tools. Within the frame of this project, advice from the agencies will be obtained on the plans and on the results of the clinical validation. A briefing book will be prepared on these aims.
WP-3: Preparation of the clinical prospective study
The objective of the WP3 is to do all preparations for the start of the "prospective
observational clinical study", which will be managed within the WP4 and to start within 15 months after the start of the project (July 2015). Major tasks of WP3 are
(i) preparation of required documents and
(ii) generation of a research use only (RUO) kit for usage during the clinical validation.
WP-4: Prospective observational multicenter confirmatory PoP clinical trial
For clinical validation of the RABIOPRED assay, consoritum will perform a 14-weeks long prospective observational multicenter confirmatory Proof of Performance (PoP) clinical trial. The main objective of the work package 4 is to perform this clinical validation for prediction of anti-TNFα treatment response in RA (Rheumatoid Arthridis) patients. Clinical study management and monitoring will be performed by professional clinical research organizations with experience in clinical validation studies for biomarkers.
WP-5: Registration of the CE-Marked IVD-kit
Upon completion of the clinical trial, WP5 shall register the in vitro diagnostic (IVD) kit of RABIOPRED as an IVD medical device and obtain an EMA market authorization registration (CE-marking). In order to register the product as an IVD medical device, Tc Land will prepare and maintain technical documentation and determine and justify what is appropriate/sufficient to assure IVD kit's compliance with the Directive 98/79 CE.
WP-6: Commercialization plan (dissemination and exploitation)
During and after completion of the project, dissemination activities play an important role. Within the project duration, these consist of:
The project and its results will be promoted via a series of communication activities, specifically aimed at relevant target audiences during the project. These activities will include internal and external communications, reporting of results to the scientific, clinical and broad community (e.g. popular scientific journals, press releases). A clinical trial report will be produced at the end of the study. The structure of the report will be in accordance with the ICH E3 - Structure and Content of Clinical Study Reports, although this standard may be not legally binding or fully applicable to IVD devices.
WP-8: Project management
This work package includes complete scientific, legal, financial and administrative management of the project. Professional management will ensure that the project’s main objectives are realized in a timely fashion and within budgetary limits. TcLand has extensive experience in managing (large) national and international R&D projects, including academic, clinical and industrial partners; and will coordinate all project activities.
For more information please do not hesitate to contact us