Regulatory Compliance | eDiaries, eClinical Data

By: Symfo  09-12-2011

At Symfo, we take steps to ensure our eDiaries, services and processes are in strict compliance with FDA, EMEA, ICH and other Regulatory Authorities requirements, guidelines and practices. Symfo is constantly reviewing the ever changing requirements for ePRO use in collecting accurate data to ensure GCP, HIPAA and CSUCT/CSUCI guidelines, practices and regulations are followed as they relate to ePRO.

All Symfo eDiaries, services and processes fall within the spirit of FDA CFR 21 part 11.

  • Symfo eDiaries are closed systems
  • Password protected
  • eClinical Data stored in encrypted format
  • Servers are closed system with controlled access

Symfo has established an internal audit policy to ensure our customers receive the quality and services they expect and depend on. In addition to internal audits, we conduct audits of our vendors and suppliers to again ensure exceptional quality and service to our customers.

Other products and services from Symfo


Phased Empowerment | Electronic Patient Records, Clinical Trials

Symfo promotes these "technology transfer" options to allow clients and partners total use of the product suite to satisfy their desires for independence. Symfo's Phased Empowerment provides customers the means to independently use our electronic patient reported outcomes technology and applications. Customers will "shadow" our project managers, study designers and trainers throughout the Subject Diary Life Cycle.


Webinars | Patient Reported Outcomes | Clinical Trial Support

Electronic Data Capture is at the center of most global trials and ePRO systems are becoming more and more popular for collecting quality data from patients. Learn how the availability of combined data promises to facilitate efficient and effective decision-making and enhance the overall drug development process. Rationale about the Webinar dedicated to: Integration of ePRO and eCRF in clinical trials.


Clinical Study Support | eClinical Trial Support, eDiary

Symfo assigns one dedicated Project Manager for the trial to insure that there's a single, permanent point of contact between the customer and the Symfo project team. Symfo provides one eDiary User Guide per patient (customized to the patient's language) which includes all relevant information about support. Symfo's Study Support consists of Project Management, eClinical Trial Support, Training and Help Desk services.


Clinical Study Building | eClinical Research, eDiary

Study building and deployment with Symfo is provided by our electronic patient reported outcome services department and follows a validated process covering every aspect of eDiary trials. Create the User Requirement Specification documentation. Set-up toll free lines for the Help Desk. Deliver data to sites and the customer. Study Closeout and Data Archival.


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.