Giuliani Pharma Spa and Ethical eClinical Solutions
Born in 1889, Giuliani Pharmaceuticals has been working for years on gastroenterology research and development, achieving groundbreaking results identifying possible new approaches in the treatment of inflammatory bowel diseases.
The research has generated projects developing new chemical or biotechnology-derived products (i.e. GED projects in the R&D pipeline).
CHORUS® the e-Crf® multi study portal
The E-CRF customized for Giuliani is currently a multi-study and multi-project platform where many studies coexist in their segregated environments.
Every project is accessible by its own set of authorized users, with the study specific profiles (Investigators, Data Entry users, CRAs, Data and Project managers, Sponsor) which grants are designed for the study specific protocol specifications.
Every project hosted in the E-CRF platform can exploit the common functions and services of the platform:
- help desk
- 27001 infra-structure
- Validation (GAMP 5, CRF21 part 11) documentation package
Every project requires taylored software packages and functions:
- Different data capturing packages (Remote Data Entry, Double Blind Data Entry or data import from legacy or third party platforms)
- Data Cleaning & Queries
- Report & Data Export
- Safety DB
- E-Data Room
SAFETY DB ® Safety Database Management
The SAFETY DB software package for Giuliani has been developed for the Pharmacovigilance Surveillance of the post-marketing effects of the products and results of the clinical trials and research activities conducted by Giuliani Pharma S.p.A.
Safety DB records and stores adverse events notification and all the collected information about the patients' history and reactions, aiding the in charge QPPV (Qualified Person for Pharmacovigilance) in the communication of the data to the Pharmacovigilance authorities.
- Creation of forms for adverse events notification (reactions, concomitant medications, drugs, reactions, hospitalizations details and medical history...)
- Data Entry operations for adverse events notification
- Data storage for adverse events notification
- Official communication forms generation (CIOMS)
- Data retrieval of AEs for notification
E-Data Room® Virtual Data Room
Giuliani Pharma S.p.A. uses the dedicated E-Data Room safe file system with the purpose of allowing access and documentation management features to users located remotely from Giuliani headquarter with the correctly assigned grants (view / download / print) only to the assigned folders and files.
Assignment rules and procedures for documentation management (creation, view, download, print):
- Closed and protected file system
- Segregated environments for each project with explicitly assigned manager roles
- Stored documents are protected from copy/save actions
- Version management: a new version of a document is considered as a new document
- Audit trail