Clinical trials
Expert CRO in clinical trials: your trusted partner for successful studies
Centaur Clinical is a CRO specializing in clinical trials for drugs and medical devices (MD/IVD). We conduct your studies in accordance with international standards and regulatory transparency requirements. Our approach guarantees risk control, impeccable data quality, and operational execution in line with the critical milestones of your clinical development.
Clinical strategy
Our clinical expertise: comprehensive management, from protocol to final reporting
We conduct Phase I to IV clinical trials in accordance with ICH-GCP, ISO 14155 (if including a medical device), and EMA/FDA requirements, with strict control of bias, data quality, and regulatory compliance.
Study design and feasibility
We carry out study design and feasibility studies, including literature reviews, clinical strategy, endpoint definition, and country/site feasibility assessments. This step allows us to establish a realistic schedule and structure the methodological basis for the trial.
Clinical trial protocols (ICH GCP / ISO 14155)
As a CRO specializing in clinical trials, we draft your protocol in accordance with ICH-GCP or ISO 14155 (medical devices): study type, duration, sites, statistical methodology, inclusion/exclusion criteria, endpoints. The protocol, IB, IC, Monitoring Plan, and SMP are prepared for regulatory submissions.
Site selection and multicenter management
Our established relationships with investigational centers and KOLs guarantee the selection of relevant sites that are suited to the requirements of your study (drug or MD).
Regulatory submissions and inspection readiness
We handle regulatory filings: RA/CEI, CPP/IRB, CNIL, ClinicalTrials.gov registrations, and interactions with the relevant authorities.
Clinical trial implementation and monitoring
Our CRAs ensure the setup of centers, training of teams, initiation of enrollments, and initial monitoring. Clinical monitoring (SDV/SDR), deviation management, safety monitoring, data review meetings, IMP management, and RBM/RbQM dashboards.
Data analysis and data management
Data cleaning, PV/DM reconciliation, query resolution, continuous quality control.
Clinical study report (CSR – ICH E3)
We draft the CSR (ICH E3) and compile the final submission dossier for notified bodies or regulatory authorities.
Post-market surveillance (PMCF/SCAC)
For medical devices, we provide post-market clinical follow-up (SCAC/PMCF) in accordance with MEDDEV 2.12/2 Rev. 8 and Regulation 2017/745.
Our areas of clinical expertise
Trials tailored to each device and each indication
Clinical trials
We manage your clinical trials for drugs and medical devices: design, protocol, monitoring, and data analysis. Our CRO specializing in clinical trials guarantees regulatory compliance (ICH-GCP, ISO 14155) and the quality of results.
Data Management
We manage eCRF, data cleaning, queries, and quality control. Our processes guarantee reliable data that is ready for FDA/EMA inspection.
Medical Writing and Technical Reports
We write your protocols, patient documents, clinical reports, PMCF, and other documents related to study compliance.
Our clinical trial processes
A controlled process, from design to regulatory submission
Our methodology guarantees compliance and data quality at every stage of clinical development.
Study Design & Feasibility
Literature review, clinical strategy, endpoints, country/site feasibility.
Study Launch
Protocol, IB, IC, Monitoring Plan, SMP, regulatory submissions, site initiation, ClinicalTrials.gov.
Conduct & Monitoring
SDV/SDR, deviations, safety, IMP, KPIs, risk dashboards.
Data Review & Close-out
PV/DM reconciliation, queries, audits, close-out visits.
Reporting & Submission
CSR, publication, submission package, CTIS/ClinicalTrials.gov transparency.
I have a clinical project
Our team sets up effective and compliant clinical studies, tailored to all classes of medical devices and each therapeutic focus.
Testimonials
What our satisfied customers say about us
We are starting a clinical investigation with Centaur Clinical and are very satisfied with our collaboration so far. Preparing the submission to the authorities is a stressful and time-consuming process that requires qualified personnel. The Centaur Clinical teams are always on hand to provide us with their expertise, availability and support.
Centaur Clinical helped us define a rationale and a clinical investigation strategy that was robust and consistent with the expectations of health authorities regarding the application of the RDM and the clinical evidence required.