INTERNAL PROMOTION
The internal promotion unit is tasked with ensuring management of those studies of which the Poitiers CHU is the promoter or the initiator.
The studies promoted by another institutional promoter (other CHUs, CLCC/cancer research centers, learned societies, etc…) are managed by the external promotion unit.
The internal promotion unit is in charge of biomedical research studies (drugs, medical devices, clinical trials other than health products), and is also in charge of routine or ongoing care studies, observational studies or research having to do with biological collections.
The tasks of the internal promotion unit
- management of requests for promotion in cooperation with the regional delegate for clinical research and innovation;
- support for researchers in preparation of their responses to tenders (the inter-regional and nationwide clinical research programs known as PHRC…);
- establishment of research budgets;
- submission of authorization applications to the different competent authorities (CPP, ANSM, CCTIRS, CNIL, Ministère de la recherche)
- management of project logistics and budgetary monitoring;
- monitoring of quality and projection management;
- vigilance management in the different trials;
- coordination and supervision of the CRAs in projet management;
- writing of research contracts for financing purposes, in coordination with the project valorisation team.
Composition of the unit
Véronique Ferrand-Rigallaud, head manager
Promotion applications, financing, tender responses
Extension: 44 665 veronique.ferrand-rigallaud@chu-poitiers.fr
Fanny Abriat, administrative and logistics manager
Technical and regulatory management, expense tracking, logistics
Extension: 43 796 fanny.abriat@chu-poitiers.fr
Sophie Duranton, pharmacist
Clinical trial vigilance
Extension: 43 050 sophie.duranton@chu-poitiers.fr
Marie Bonnin, projet manager
Project management – quality procedures
Extension: 43 317 marie.bonnin@chu-poitiers.fr
EXTERNAL PROMOTION
In the research directorate, the external promotion and innovation unit exercises two main functions:
- centralized management of industrially and academically promoted clinical trials;
- support for medical teams wishing to develop and carry out projects having to do with innovation and costly treatment procedures.
Composition of the external promotion and innovation unit:
Sarah Guyon, head manager
Telephone : 05 49 44 39 37
E-mail: sarah.guyon@chu-poitiers.fr
Aude Malézieux, administrative agent
Telephone: 05 49 44 34 04
E-mail: aude.malezieux@chu-poitiers.fr
The tasks of the external promotion and innovation unit
A – External promotion:
Its overall purpose is to ensure follow-up of applications for conduct of trials designed for external promotion, that is to say industrial and academic trials in which the Poitiers CHU positions itself as a service provider.
Its roles are: 1) to receive the application; 2) to verify – with the promoter – the completeness of the study dossier; 3) to evaluate – in collaboration with the main CHU investigator – possible induced costs, 4) to propose and to sign – in agreement with the promoter – a hospital contract. The final step is the indispensable regulatory prerequisite prior to CHU authorization to conduct the study.
The external promotion unit ensures administrative and financial monitoring of academically or industrially promoted clinical trials from setting up through the completion of the study.
In addition to monitoring the financing allocated for implementation of the study, the unit may be called upon to manage the “honorarium” packages awarded to investigators who wish to have their payments remitted to the hospital in the context of privately promoted trials. In this case, establishment of a three-party agreement between the promoter, the investigator and the CHU is recommended.
The second purpose of external promotion is to recruit and manage the research staff paid by the CHU of Poitiers [example : CRA (clinical research assistant), TEC (clincial study technician), engineer, research technician, nurse researcher…] through external funds [financial support from the pharmaceutical industry, association, INCA (national cancer institute), DGOS (care provision management), CENGEPS (health product trial management…].
This type of coordination is applicable:
i) As concerns professional assessment and training, each professional is subject to professional assessment established by investigating physicians. Training requests are managed in coordination with the continuous training unit (service de la formation continue);
ii) As concerns finances by monitoring budgets allocated to staff and employment contracts;
iii) As concerns functioning, in cooperation with human resources management for signature of the contracts.
B – Innovation :
It is tasked with promoting innovation in the CHU by facilitating the elaboration of the protocols with an economic as well as medical aspect that are submitted national calls for tender known as “program of support for costly innovative techniques – PSTIC”. This support program involves only innovations having been validated in the context of a preliminary stage of clinical research and that could have a major impact on the health care system.
The STICs are multicenter nationwide programs, financed for a 2-year period, that permit dissemination of a technique and analysis of its medical and economic impact in comparison with a more traditional treatment approach. The budget allocated to a STIC is remitted in its entirety to a coordinating center, which distributes parts of it to the different participating centers according to the number of patients included.
The STIC for illnesses other than cancer is coordinated by the organ known as DGOS (care provision management).
The cancer-related STIC has been coordinated by INCA (the French national cancer institute) since 2005.
If you wish to coordinate a STIC project as a principal investigator (PI) or participate in a STIC project as a co-investigator, contact Sarah Guyon, the innovation manager, at 05 49 44 39 37 or sarah.guyon@chu-poitiers.fr.
The other main task of the innovation unit consists in managing STIC research projects initiated by the CHU of Poitiers or by external promoters. The unit controls and monitors STIC budgets, validates orders, and writes and follows up on financial agreements.
In 2013, the STIC was superseded by the Programme de recherche médico-économique (medical and economic research program). .
PROTECTING YOUR RESEARCH
In 2008 the DRCI (clinical research and innovation delegation), in coordination with the Grand-Ouest GIRCI (inter-regional clinical and research and innovation grouping) equipped itself with a unit for valorisation of innovation and technology transfer. The term “valorisation” covers the entire scope of relations between public research and the socioeconomic environment.
The main task of this unit consists in protection of the data and results of clinical, translational and academic research. It is closely coordinated with the partnership and research valorisation of the University of Poitiers.
The protection of what you have discovered, invented or created enables you to retain mastery over its commercial, publication-related or other utilization. Your invention being the fruit of long years of research and reflection, it should be a source of profit for yourself and your institution.
Research in partnership
Quite often, you carry out research in the framework of academic or private partnership. Your research is backed up by a contract stipulating, among other things, cash flow, intellectual property and publication.
Our role is to protect your interests as you negotiate the contract.
How to provide protection?
– The initial reflex: the nondisclosure agreement.
When you discuss your project with potential partners or private funders, make sure you sign a nondisclosure agreement.
– If you think that your project can be the subject of a patent application or of any other type of protection, contact the valorisation unit or send us your duly completed invention declaration file.
(Article L611-7 of the intellectual property code stipulates that all employees are required to declare their invention to their employer. As regards the employees of the Poitiers CHU, their inventions must be declared to the general director.
