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 with innovative technologies, through its business processes, AdvicePharma manages to obtain the maximum in terms of speed and efficiency of its services.
The data management and biostatistics teams in AdvicePharma are organised to keep 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:
- Strategic clinical development consulting
- Clinical trial planning and design
- Study protocol development
- Project management
- CRF/ eCRF design
- Database design and development
- Data entry
- Data Management
- DCF / query management
- Remote monitoring
- Management of clinical data from external sources (laboratories, devices, images)
- Statistical analysis and reports (Biostatistics)
- Medical writing (study reports, results publication)
- Digital integration
Electronic Data Capture (EDC)
Acquiring clinical data quickly and accurately is crucial for the success of a study.
The ability to design, build and implement high quality EDC platforms and databases allows AdvicePharma to compete in the global market of pharmaceuticals and medical device development.
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 user training and implementation of the EDC platform phases.
AdvicePharma is able to develop different EDC solutions, for 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
- Easy to use design environment: no IT skills required to design an eCRF
- 100% web-based technology
- Compliant with FDA Guidelines
- Built-in eQuery module with edit check system
- Real-time data export: compatible with different formats (SAS, excel, SPSS, R)
- Real time randomisation module
- Innovative system structure based on several different databases
- Key study management modules already built‑in on the platform (e.g: Clinical Trial Management System, AE Modules)
- Customised reports with online access
- Security-compliant architecture provides a protected environment for your data
- Geographical distributed and redundant back‑up of server data
- On-line training for platform users
- Compliant with the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679)