CLINICAL OPERATIONS & SUPPORT

Clinical operations, from protocol to publication.

For both first-time and experienced sponsors. From methodological scoping to regulatory submissions (CPP/ANSM, RIPH/Jardé), through investigator-sponsor support (CRA/CRC) — your single point of contact throughout the study.

RIPHJardé law compliance
CRA/CRCinvestigator-sponsor support
CPP · ANSMturnkey submissions
+18 yrsof field expertise

Four pillars to secure your study

From methodological scoping to submissions, site management and final valorisation — one point of contact from protocol to publication.

01

Methodological scoping & protocol

Study design definition, protocol drafting or revision, synopsis note, feasibility dossier.

02

Regulatory submissions

Preparation and submission of CPP and ANSM dossiers, management of RIPH authorisation requests (1, 2, 3), Jardé law compliance, MR-001/MR-003.

03

Investigator-sponsor support (CRA/CRC)

Provision of CRAs (Clinical Research Associates) and CRCs (Clinical Research Coordinators) for site management and field monitoring.

04

Publication support

Structuring study data for scientific publication, medical writing, submission to peer-reviewed journals.

Regulatory framework covered

ICH E6 (GCP)ICH E3ICH E9ISO 14155RIPH 1RIPH 2RIPH 3Jardé lawMR-001MR-003CNILCPPANSM

One single point of contact, end to end

First-time sponsors

We guide you from A to Z: scoping, design selection, submissions, site management. No in-house clinical team required.

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Through to publication

We don't stop at database lock. Data structuring, medical writing and journal submission to maximise the value of your results.

Launching a study?

Methodological scoping, regulatory submissions or CRA/CRC support — present your project to us.

Present my project