AdvicePharma is able to provide a full range of services for the collection of clinical data and clinical data-management. By integrating the professional skills of staff with innovative technologies, through its business processes, manages to obtain the maximum in terms of speed and efficiency of its services.
The data-management and biostatistics team of AdvicePharma is organized in such a way that keeps customers projects on time and on budget, by providing timely strategic information to the project team through the continuous monitoring of the evolution of the study.
The AdvicePharma services comprise:
- Project Management
- CRF/ eCRF design
- Database design and development
- Data Validation Plan preparation
- Data Cleaning
- Data Management
- DCF / Query Management
- Management of clinical data from external sources of the study (laboratories,data from device, images)
- Coding of AE / CONMED listing
- Reconciliation of SAE
- Statistical analysis and report plans(Biostatistics)
- Production and management of the DBSM
- Regulatory Affairs
- Integration of safe lists/ effectiveness (ISS & ISE)
- Preparation of statistical components
Electronic Data Capture (EDC)
Acquiring clinical data quickly and accurately is crucial for the success of a study. A system that allows for a quick and properly structured data collection therefore becomes a valuable tool for anyone who deals with clinical research.
The ability to design, build and implement high quality EDC platforms and databases which allows the AdvicePharma team to compete in the global market development of pharmaceuticals and biomedical. The sector that is in continuous evolution and that requires companies to collect and distribute data faster than ever.
AdvicePharma provides services for gathering clinical data (Electronic Data Capture/EDC) and pays particular attention to the reduction in the times for the design of these. Starting from the development and validation of the database up to the optimization of the the user training and implementation of the EDC platform phases.
AdvicePharma is able to develop different solutions for Electronic Data Capture (EDC), for logs and single or multi center studies, and make them all operate in an efficient way. In this way offering customers a wide range of solutions that fit their needs.
The solution offered by AdvicePharma is powerful and flexible with respect to project adjustments. Respects the FDA regulations for the recording of electronic data (21 CFR Part 11) and allows online access to the database in various formats, so as to display the data in the preferred form.
The EDC AdvicePharma EDC system comprises:
• Electronic Medical Records for data collection
• Audit trail
• Moduli di arruolamento e randomizzazione dei pazienti on-line
• Creating automatic and manual queries, resolution and traceability
• Tools for monitoring the study
• Portal for document archiving and management
• Reporting Tool that is flexible in customization and intuitive in use
There is therefore the possibility to help customers take advantage of the new technologies for the EDC; reaching the best efficiencies for an increasingly easy and quick access to your data with a reduced number of paper documents, temporal cycles reduced, increased productivity and improved relations with customers and suppliers.
