Blog
Resources on academic clinical research
In-depth articles written by Marie De Solère, clinical research promotion coordinator, drawing on her hands-on experience in academic clinical research. Methodology, regulation, funding — the fundamentals for structuring your projects.
Calcul de la taille d’échantillon : les paramètres clés
Le NSN est l’une des sections les plus scrutées d’un dossier CPP, DRCI ou PHRC. Les paramètres à préparer avant de contacter son biostatisticien, la distinction entre différence cible et taille d’effet standardisée, et la bonne logique de dimensionnement selon le type d’étude (comparative, descriptive, diagnostique, pilote).
Marie De Solère13 min read
Investigator and DRCI: roles, responsibilities and friction points
The investigator ↔ DRCI relationship is at the heart of every academic clinical study — and the most common source of delays. A map of the roles, the distinction between investigator-side and sponsor-side CRAs, 5 recurring friction points and best practices to smooth collaboration.
Marie De Solère9 min read
Information sheet and informed consent in clinical research
The information sheet and the informed consent form (ICF) are among the documents most often sent back for revision by ethics committees (CPP). Distinguishing the two documents, the expected structure, adaptations by RIPH category and drafting mistakes to avoid.
Marie De Solère7 min read
PHRC, PREPS, PHRIP, PRME: clinical research funding calls
Understanding PHRC, PREPS, PHRIP, PRME, RHU, FHU, IHU and the Émergence calls — their differences, timelines and selection criteria — to plan 12 to 18 months ahead and submit a competitive application.
Marie De Solère8 min read
RIPH classification, RNIPH and European regulation
Every clinical study in France falls under a dual regulatory framework — national (the Jardé Law: RIPH 1/2/3 or RNIPH) and European (CTR, MDR, IVDR). This article offers a step-by-step decision logic and an operational summary table.
Marie De Solère12 min read
Writing a clinical research synopsis
The synopsis is the entry point into the DRCI process. Structuring it well saves weeks in maturing the project. Expected sections, common mistakes and recommendations.
Marie De Solère5 min read
The PICO method in clinical research
PICO breaks the research question down into four dimensions — population, intervention, comparator, outcome — that then drive every methodological decision. An overview of best practices and common mistakes.
Marie De Solère6 min read