Services

Data Management


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Integrity, transparency and reliable clinical data

With over 15 years of experience in Biometrics, OPIS can provide advice and assistance to clients for choosing the most appropriate technology to collect and handle clinical data depending on the specific study features.
The Data Management team and the Clinical IT team closely collaborate on the development and customization of the proprietary electronic data capture (EDC) system, and on ensuring full System and study-specific Validation and FDA CFR Part 11 compliance.

Our data management applies standardized and established processes from CRF design to database lock, including eCRF/database creation (CDISC or customized to company requirements), IVRS/IWRS set-up, edit check implementation and query management, status project and metrics reports, medical coding, reconciliation of serious adverse events and third-party data handling.

Data are securely stored in our servers for the entire period of the study, and all our procedures are ICH/GCP and GDPR compliant.

Regulatory
Trial Start-Up
Study Management and Monitoring
Data Management
SAS Programming
Statistical Analysis and Consultancy
Pharmacovigilance
Quality Assurance
Medical Affairs and Medical Writing
Preclinical and Drug Development Consultancy
Project Control
e-Clinical Platform - OPIS CLINICAL.NET