DataRiver is an innovative SME, self-certified as a Contract Research Organization by the Italian Medicines Agency (AIFA) and Associate Member of the European Big Data Value Association. The company provides services and consultancy in the field of Clinical Data Management, Big Data Integration & Analytics and Artificial Intelligence and develops innovative software solutions for clinical trials, rare disease and pathology registries, patient support program (PSP), patients monitoring and telemedicine platforms.
DataRiver has an extensive experience in clinical research projects promoted by hospitals, research institutes, pharmaceutical and biomedical companies around the world. The company performed clinical data management and integration activities in observational and interventional phase I-IV clinical studies in the following fields:
- Oncology
- Hematology
- Rare Diseases
- Cardiology
- Infectious Diseases
- Neurology
- Endocrinology
- Gastroenterology
- Pneumology
Thanks to the knowledge and expertise in clinical data management as a Contract Research Organization, DataRiver is able to manage, to provide support and in-depth consultancy for the clinical databases management in compliance with the GCP, the international regulations and standards for personal and clinical data processing, offering the following services:
Data Management:
- Design, planning and development of eCRF
- Data Management Plan (DMP)
- Generation and management of randomized lists
- Definition of Edit and Validation Check
- Implementation of IQ, OQ and PQ
- Data cleaning management
- EDC, ePRO and IWRS management
Statistics:
- Protocol development
- Sample size calculation
- Statistical Analysis Plan
- Programming and Data analysis
- Statistical reports drafts
- Artificial Intelligence Analytics