PRE STUDY ACTIVITIES

 

Trial planning and set-up - Synopsis and protocol writing - Informed consent  form writing - CRF and patient diary design - Investigator's brochure and IMPD writing - Feasibility and clinical sites selection - Pre study visit

CLINICAL TRIAL START-UP

 

Submission to ethics committees - Submission to competent authorities - Contracts with sites and other facilities  - Update of clinical trial application data - Local insurance policies

MEDICAL WRITING

 

Clinical study report (ICH compliant) - Clinical Study protocol - Investigator's brochure - Clinical and scientific articles and abstracts - Training and marketing materials - Medical Adviser Board reports - Operating procedures - Bibliographic research - Posters - Translations

PROJECT MANAGEMENT

 

Sites coordination - CRAs coordination - Check of study status - Updates to sponsor - Project meetings

MONITORING

   

Initiation visit - Monitoring visit - Close-out visit - Remote monitoring

DRUG MANAGEMENT

 

Storage of IMP in compliance with CGMP and GLP standards - IMP supply managements - IMP packaging and labeling

PHARMACOVIGILANCE

 

24H/7d service - Eudravigilance users management - SUSAR management - DSUR preparation and submission

OTHER SERVICES

 

Investigators' meeting organization - Training - Study products/biological samples shipment - Centralised analyses - Pre-clinical tests for drugs / devices / food supplements / cosmetics