Clinical Study Building | eClinical Research, eDiary

By: Symfo  09-12-2011
Keywords: Help Desk, Data Archival

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

Keywords: Data Archival, Help Desk

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Regulatory Compliance | eDiaries, eClinical Data

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Services | eClinical Solutions, Clinical Data Integration

Symfo's ePRO Services department consists of experienced project managers, study designers and trainers dedicated to ensuring your smooth transition into the world of eDiaries. Symfo has built a sterling reputation on exceptional customer service - and that means we'll provide the most comprehensive and timely full service solution as required.