Latis deals with the entire life cycle of a clinical study from the design to the delivery of the final report - offering also customized services, including pre study activities, drug management, medical writing, data management, statistics, etc..
The company's goal is to achieve the clinical study quickly and effectively, finding flexible but reliable solutions.
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