CRO

DataRiver is certified by AIFA as CRO, in accordance with the Italian Ministry of Health Decree DM 15/11/2011.

DataRiver implemented a Standard Operating Procedures system to document and manage collection, management and processing of clinical data throughout the whole study period, certifying the compliance of hardware and software platforms to:

  • Computer System Validation

and of processes to:

  •  ICH Guidelines for Good Clinical Practice
  •  21 CFR Part 11 (Electronic Records and Electronic Signature)

 

Our services include:

DATA MANAGEMENT STATISTICS
Data Management Plan (DMP)
Design, planning and development of eCRF
Definition of Edit and Validation Check
Processing and management of randomization lists
Perform of IQ, OQ and PQ on eCRF
Data cleaning
Medical lists scheduling
Management of EDC, ePRO and IWRS
Data transfer
MedDRA encoding
Draft of Statistical Analysis Plans (SAP)
SAS and SPSS programming
Statistical reports drafts
Intelligent analytics
THERAPEUTIC AREAS
Hematology
Oncology
Cardiac Surgery
Cardiology
Hepatology
Infectious diseses
Neurology
Nephrology
Pneumology
Gastroenterology
Rare diseases