Study Building & Deployment
Study building and deployment with Symfo is provided by our electronic patient reported outcome (ePRO) services department and follows a validated process covering every aspect of eDiary trials. This process, called the Subject Diary Life Cycle (SDLC), is defined in our SOPs and ensures consistent and quality project delivery, while supporting all regulatory requirements.
The process manages the various stages of the study, including:
Project Initiation
- Study Design consultation
- Workflow consultation/establish schedule
- Create the User Requirement Specification (URS) documentation
Study Building
- Order devices and materials (if required)
- Establish project specification document
- Create Functional Requirement Specification
- Generate deployment plan
Study Deployment
- Set-up toll free lines for the Help Desk
- Institute the correct support personnel
- Organize and deliver training
- Generate User Guides and other support documentation
- Deploy the materials
Ongoing Study Management
- Remain in contact with the customer
- Perform regular testing
- Maintain help desk support
- Implement mid-study changes, if required
- Maintain study metrics
- Document Trial Master File
Study Closeout and Data Archival
- Archive eClinical research data
- Deliver data to sites and the customer
- Closeout meeting with project teams