The platform

    Presentation

        Purpose - Missions - Values

        History and Organizational structure

        Activities

    The team

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Presentation

Purpose – Missions – Values

Purpose

As a reference platform in France, the Bordeaux PharmacoEpi platform (BPE) carries out pharmaco-epidemiology studies with a high scientific level to evaluate the impact of drugs in real life settings.

The results of these studies aim to be published and participate in the development of recommendations to optimize the benefits and minimize the risks of drugs.

Missions

Thanks to its expertise, its strong technical and professional capacities, the BPE ensures the following missions:

  • Promotes public and private partnerships to generate knowledge related to medicines in Public Health both in France and internationally,
  • Defines and conducts research to evaluate, in real life settings and on a large scale, behaviours regarding drugs prescriptions and drugs utilization patterns as well as their impact on health and costs,
  • Answer to questions from regulatory authorities and pharmaceutical companies regarding the assessment of drugs and therapeutic strategies (risks, use and performances) after their marketing authorization (“PASS, PAES, HTA” studies),
  • Carries out expert and training missions complementarily with Bordeaux University initial and continuing training offer.
Values

Our requirements for the performance of our activities are multiple: quality, confidentiality of data, regulatory compliance, deadlines and budget respect.

Our Motto: : « The impossible is routine, the unthinkable is fun! »

Our values, reflect of our identity and ambitions, are based on the following principles:

  • To promote creativity and scientific excellence in pharmacoepidemiology studies,
  • To guarantee intellectual, institutional and individual independence,
  • To ensure partner satisfaction through passion, dynamism and innovation,
  • To lead a collaborative, committed and daring project management,
  • To ensure the teamwork values: caring, benevolence and respect.

History and Organizational structure

The BPE was created in 2002 and was accredited by INSERM in 2008 in the pharmacoepidemiology thematic of the Bordeaux Clinical Investigation Center 1401 (CIC 1401) (partnership between Institut Bergonié, CHU de Bordeaux, Université de Bordeaux, and INSERM). The BPE platform is supported by ADERA (subsidiary of Université de Bordeaux and other cultural and professional scientific institutions in the Nouvelle Aquitaine region) since 2008 for some management activities, in particular concerning human resources and legal affairs. The BPE platform is registered with ENCePP since the creation of the network and is referenced on the list of the EMA procurement procedure for drug safety studies. In 2019, BPE was certified ISO 9001:v2015 for its activities related to pharmacoepidemiology and as Plateforme de recherche de l'Université de Bordeaux.

The BPE platform also follows the European guidelines of the discipline, respects the ENCePP code of conduct, with registration of its studies in the EU PAS Register (European Union electronic Register of Post-Authorisation Studies), including 8 with the ENCePP seal securing transparency and quality.

BPE has been doing studies in pharmacoepidemiology for over 15 years now, with a high scientific level, supporting to the scientific community and to socioeconomic partners through its expertise, know-how, skills, to meet population health needs.

Activities, technical and professional capacities

Watch the video  (french speaking)

BPE platform can thus ensure its missions of study realization, consulting and expertise in the field of pharmacoepidemiology, at the national and international levels. Since 2003 and the CADEUS* project, the BPE platform has done various studies (cross-sectional studies, cohort studies, case-control studies) in many therapeutic areas, within different data sources: more than 30 field studies (50 to 46,000 patients) and more than 50 studies using secondary data from existing databases such as the French nationwide claims database (Système National des Données de Santé - SNDS). Whatever their development phase, BPE manages 60 active projects per year in average (inception, design, implementation, publication), and has published more than 100 scientific papers in peer-reviewed journals over the last 5 years.

The originality of the BPE platform lies in its permanent structured team of around 30 people. It thus has all the skills to carry out studies in pharmacoepidemiology on the same platform: this organization facilitates the study management through the use of efficient operational tools, and thus optimizes the quality of data and results so they can be submitted to health authorities and sponsors in due time.

*Public health study conducted in France on 46,000 patients on the use of non-steroidal drugs (coxibs and NSAIDs).
BPE Study creation process description

The Team

The BPE platform has a permanent team of around 30 people. This logistical and operational support team is made up of all the needed professions to carry out pharmacoepidemiological studies: physicians, pharmacists, epidemiologists, project leaders, team leaders, data managers, statisticians, database programmers, clinical research assistants, administrative agents as well as a secretarial / accounting unit. This team is located on the same operational platform (nearly 1,000 m2), which facilitates the management of studies through the use of efficient operational tools, and thus optimizes data and results quality to be submitted to health authorities and sponsors in the required timeframe.

The size of the team is adapted to the projects conducted by BPE by integrating and training new staff as needed. Training and teaching are an integral part of the activity of the BPE team, which regularly participates in teaching at Bordeaux University (Master 2 de PEP-PV, DIU ToMARS, DIU FARC-TEC, DU PEP).

President

Nicholas Moore

Director

Cécile Droz-Perroteau

Scientific Officer

Nicolas Thurin
Pauline Bosco-Lévy

Regulatory aspects

Caroline Dureau-Pournin

Quality Assurance Manager

Séverine Lignot-Maleyran

Project Leader

Caroline Dureau-Pournin
Angela Grelaud-Boussinot
Séverine Lignot-Maleyran
Magali Rouyer-Colombier

Assistant Project Leader

Adeline Grolleau
Estelle Guiard
Stéphanie Lamarque

Team Leader

Aurélie Balestra
Emmanuelle Bignon
Pauline Diez

Accountant

Nathalie Vidal

Clinical Research Assistant

Internalisation
+ recruitement if needed

Assistant Accountant

Caroline Florit

IT Manager / Database Manager

Patrick Bouex
Ludovic Liège

Database Programmer

Jérôme Dupont
Romain Sylvestre

Data manager

Jérôme Dupont
Romain Sylvestre

Senior Statistician

Abdelilah Abouelfath
Marie-Agnès Bernard
Jérémy Jové

Statistician - SAS® Programmer

Clémentine Lacueille
Clélia Favary
Dunia Sakr

Medical Writer

Internalisation
+ recruitement if needed

Secretary

Internalisation
+ recruitement if needed

IT

Internalisation
+ recruitement if needed