Clinical Research
Clinical Trials
- Clinical project Management : Early and Late Phase, interventional and non interventional
- Document management : Archiving, TMF and CTMS management
- Study management : Budget, timelines and human resource management
- Study documents writing : Sites financial agreement, inform consent
- Monitoring : Feasibility and site selection (pre-selection site visit), Initiation, monitoring and close-out visits
- CRO Management : Selection and vendors management (central lab, IVRS/IWRS, e-COA, e-PRO...)
- Clinical Supply Management
- Medical review : Patient listing review, safety review
Medical Writing
- Scientific publications : abstract, poster and article
- Writing and review of the clinical study protocol (CSP)
- Clinical sudy report (CSR)
- Clinical evaluation (CEP/CER)
- Study Writing : Synopsis, protocol, IB, ICF
- CTD Modules
- 2.5 ; 2.7 clinical
- 2.4 ; 2.6 preclinical
Biometrics
- Biostatistics
- Programming : SAS, R, Python
- Data Transfer
- Data Science
- Data engineering
- Artificial Intelligence : machine learning, deep learning, imaging processing...
- Clinical Data Management
- CDISC - SDTM standard management
- Bio - informatics
Quality
- GCP/GVP : CAPA set-up, deviation and complaint management
- Quality System : Implementation of the Quality Management System
- Post Approval Inspection
- SOP Writing
- GDPR management
- CSV (CQV)
Regulatory Affairs
Pharmaceutical
- Regulatory Submissions (CTA/IND)
- Market Autorisation registration, modification and renewal
- Publishing, eCTD Management
- Labelling and promotional information control
- Module 3 CMC Dossier, site transfert
- Portfolio activities
Medical device
- UE 2017 754
- UE 207 / 2012 eIFU
- Regulatory submission
- Writing of CE marking dossiers
Safety
- Case management : tracking, data entry, follow up and closure management
- Narrative writing
- PBRERs writing (PSUR/DSUR)
- MedDRA and WHODD coding
- Signal detection and imputability
- Answer to medical information questions level I, II and III
- PSMF
