Symphony EDC

….simphony EDC arithmos

Electronic Data Capture Solution

Symphony EDC is a proprietary Software as a Service (Saas) Electronic Data Capture solution designed by an investigator and developed by Arithmos. The goal of Symphony EDC is to enhance the overall drug and device development process in terms of greater efficiency, effective decision-making and cost-cutting measures.

Symphony EDC is the perfect solution for:

Phase I-IV drug studies
Medical Device studies
Academic Research studies
Investigator Initiated Studies (IIS)

symphony EDC User Friendly InterfaceinterfaceUser Friendly Interface

Symphony EDC allows Sponsors to define their own workflow. It includes an intuitive interface to define system, study user roles and manage accounts without technical IT support.

User Friendly Interface

The system is totally web-based and accessible through most common browsers. Clinical data is accessible through a HTTPS protocol. This is supported by the majority of device desktop classifications. Each Client has a dedicated home page in which you can add:

  • Organization name
  • Email reference
  • Logo
  • News and documents

The system allows navigation, data entry, SDV and data management activities through graphical tabs and icons.

Symphony EDC Independent Study BuildIndependent Study Build & Management

Symphony EDC allows the clinical study team to build studies autonomously including the programming of edit checks. Hence, trial set-up is quick and straightforward with minimum training. The study team can have a trial up and running in just a few days.

 

Independent Study Build & Management

 Is your study set-up often time consuming and requires too much involvement from your IT provider?

Symphony EDC is designed to eliminate the burden of tedious study set-up and having to rely on technical experts to get your study set up. Any member of the organization, even those without programming skills, can work independently on study build and management after just a few days of training. This puts study control in the hands of the operations team.

Symphony EDC has an interactive graphical interface to easily define edit checks. Arithmos supports end users during study build with a detailed User Manual and a customized training program.

symphony EDC arithmos

Symphony EDC Electronic Data Capture Solution Reusable LibraryReusable Global Library Forms

Symphony EDC accelerates your study timelines with re-usable forms within its global library such as eCRF questionnaires and edit checks.

 

Reusable Global Library Forms

Symphony EDC allows end users to design standard and customized eCRF or Edit Checks pages and then store them in the eCRF Library.

This feature saves the Sponsor time when having to create eCRF pages for a new study. The eCRF Library provides the Sponsor with templates based on the company’s standards. These templates are then reusable and customizable guaranteeing flexibility as well as a high quality of data.

 

Symphony EDC Electronic Data Capture Solution High security levels with Easy Account User ManagementHigh security levels with Easy Account User Management

Information security is a top priority in the life sciences sector. Arithmos is an ISO 27001 certified company with an Information Security Management System that ensures compliance with regulatory standards, evaluates potential risk, maintains data integrity and implements a disaster recovery plan.

High security levels with Easy Account User Management

Arithmos is ISO 9001:2008 certified in the provision of hosting, Help Desk, system support and assistance and software application development.

 In 2014, ARITHMOS implemented its own Information Security Management System (ISMS) in compliance with the ISO/IEC 27001:2013 international standard, therefore obtaining certification from an accredited institution.

This objective stems from an understanding of the importance of protecting information and data in the Life Science environment, especially for those organizations conducting clinical studies and managing various types of data in different forms using different types of technology, including cloud-based applications such as Symphony EDC.

Implementing and certifying an Information Security Management System according to the ISO/IEC 27001:2013 standard guarantees an approach to the management of information security regarding confidentiality, integrity and availability.

We understand that clinical data is extremely valuable for our clients, and therefore it is necessary to guarantee the security of data in the appropriate manner.

Within the System Administrator account the Client can autonomously create new accounts, including other System Administrators if needed. They are able to link them to existing roles, or create new ones.

A “speaking” set of roles allows the administrator to manage different levels of access and permissions without technical competencies.

 

Symphony EDC Electronic Data Capture Solution Audit History and Electronic SignatureAudit History and Electronic Signature

Ensure regulatory compliance through automatic archiving of your audit history directly on the platform.

 

Audit History and Electronic Signature

Symphony is totally compliant with the requirements related to 21 CFR Part 11 and Annex 11. Symphony also guarantees adherence to industry standard security protocols.

The Symphony System supports audit trails at item level. The audit history of each field is available for all users through the data entry interface. The Symphony System, in addition, allows exporting the audit trail from the reports section

Symphony EDC Electronic Data Capture Solution Document Sharing & ManagementDocument Sharing & Management

Symphony EDC provides dedicated space where clinical study teams can publish documents and share information at System or Study level with Private or Public rights. This space can also be used to recruit potential sites for upcoming trials.

 

Document Sharing & Management

Symphony EDC offers a “public trial space” where the study team can share documents related to the trial for authorized users. Users can manage settings to modify controls and security of the information stored in this virtual archive. In this section users are therefore able to:

  • Upload documents related to clinical studies
  • Share important information and documents with the study team through a virtual database
  • Manage settings and access controls to protect the confidentiality of documents
  • Maintain an archive of documents and trial information for traceability and audit trails

Symphony EDC Electronic Data Capture Solution eLearning ModuleeLearning Module

Symphony EDC eLearning Module is a web-based training tool created to ensure a fast and effective knowledge acquisition for end users.

eLearning Module

Constant training represents a key issue in Life Sciences industry. Difficulties are most often seen in the preliminary phases of a study when users receive inadequate training from unqualified instructors. Initial training can also be a cost burden for companies who need to allocate costs for travel and logistics.

For this reason, Arithmos created a predefined platform to ensure fast and effective training of Symphony final users based on the specific study roles.

The module allows each user to verify the acquired knowledge by taking a final exam (with customizable minimum positive results) and obtaining the official certificate.

Customers can upload multiple videos per each class which users will watch before performing the questionnaire.

After successfully passing the exam, the eLearning, by interacting with the Symphony EDC system, will automatically unlock the user account.

Symphony EDC Electronic Data Capture Solution Randomization ModuleRandomization module

Easy to use randomization module for simply designed studies

 

Randomization module

The randomization module consists in a simple edit check that user can configure at system level. It is possible to configure a question or item that will work as a trigger and activate the process based on a pre-uploaded randomization list (only study stratification available at the moment). As soon as the specific data has been entered, Symphony assigns the first available number from the randomization list. This module was specifically developed for simply designed studies.

Discover more about Symphony EDC Electronic Data Capture Solution!
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