Tailored solutions
Our CRO services can be tailored to your specific needs. You can contact us for direct services for you alone, or for you and your partners.
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Medical Writing
Document writing
(synopsis, protocols, patient information leaflets, CRF, protocol for therapeutic use and data collection)
Report writing
(clinical reports, periodic reports related to early access programs)
Showcasing of results
(publications, posters, abstracts)
Creation and revision of regulatory applications
(CTDs, CERs) -
Regulatory Affairs
Regulatory advice on clinical studies or investigations
Preparation of the submission package (Directive 2001/20/EC) or CTIS (European Regulation No. 536/2014) -
Biometrics
Data Management (Ennov Clinical software)
Documentation (DMP, DVP)
Data entry platform with edit check programming and query management
Randomization (IVRS, IWRS)
Data coding based on MedDRA & WHODrug
Registry generation, data review (blind review) and database locking
Import of external data (biological test results, compliance, medical device)
SDTM Mapping (CDISC)
Statistics
Writing of the protocol’s statistics paragraph with calculation of the number of subjects required
Writing of the statistical analysis plan with a list of TFLs
Programming of analyses and generation of statistical tables
SAS programming platform
Tools validated according to Gamp5 recommendations -
Monitoring (CRA)
Site initiation
on site or remote – individual or global
On-site or remote monitoring visits
with reports and action plan follow-up
Quality control visits
for observational studies
Site management
query management, motivation, reminders and site support throughout the study
Site close-out visits
on site or remote -
Investigation site support (CRT)
Screening, contacting patients, organizing appointments, patient follow-up
Data entry in the e-CRF
Help with managing DCFs
Stock management (CRF, kit, forms)
Various administrative tasks
Presence during monitoring visits -
Vigilance
Pharmacovigilance
MD vigilance
Vigilance for clinical trials on “non-health products”
Cosmetovigilance
Nutrivigilance -
Project management
A dedicated team and a single point of contact for each project
Experienced managers
Quality assurance control
Management plan preparation and updating
Coordination of tasks, resources, scheduling and the budget
Risk management approach
Procedures
Our teams are flexible when it comes to using sponsor (industrial or institutional) or Euraxi procedures on a project. They are quick to adapt, having already worked with a variety of shared directories (sharepoint), eCRFs (Medidata Rave, Ennov), eTMFs (implemented in client systems) and IRTs (Calyx, Almac).
![](https://www.euraxi.fr/wp-content/uploads/2022/05/img1-1024x683.jpg)