Clinion™ – Clinical Trial Solutions

Clinion™ is a 21 CFR Part 11 validated Intuitive Electronic Data Capture (Intuitive EDC) and Clinical Data Management (Paper Study) platform.Clinion™ is focused on reducing the new product time-to-market for Pharmaceutical, Biotech and Medical Device Organizations by providing a highly configurable and user-friendly Clinical Trials Application.

Clinion™ is easy to use and configure and does not require any hardware and software requirements from the client.It is available online and can be securely accessed from anywhere by authorized users.

It is available online and can be securely accessed from anywhere by authorized users.

Features

  • Clinion™ Competencies:

    • On-Demand, Web-Based EDC & CDM.
    • 21CFR Part 11 compliant.
    • Intuitive Data Capture features.
    • High system scalability [Multisite, Multi User Trials].
    • Paper Trial Mode.
    • Easy Study CRF design and Edit Checks setup.
    • Customized Reporting and Dash Boards.
    • Multiple formats for Data Extraction.
    • Medical coding using Standard Medical Dictionaries.
    • Data Extraction
  • Clinion™ Modules

    • Study Builder
    • Edit Checks configuration
    • Study Dashboard
    • Data Capture
    • Data Loader
    • Clinical Data Management
    • Unscheduled Visits
    • Medical Coding
    • Discrepancy Management
    • Standard Reports
    • Data Extraction
    • Audit Log
    • Study Documents Repository
    • Profile Setup
    • Create Site
    • Lock Study/Site
    • Permissions Management
    • Global Libraries
    • Deploy study
  • Clinion™ Highlights

    • US FDA 21 CFR Part 11 validated system
      • Electronic Signatures & Records
      • Secure, Role Based Access
      • Audit Trail
    • Intuitive User Friendly Interface
      • Easy to configure study builder and edit checks
      • Intuitive CRF pages for ease of data entry
    • Hybrid EDC & CDM Solution
      • EDC and CDM studies can be deployed from the same system
      • Common Study Builder and Administration

System Validation & 21 CFR Compliance

  • Clinion™ has been audited for 21 CFR part 11 compliance
  • Software development compliance audit has also been carried to ascertain standard Software Development Life Cycle (SDLC) methodologies have been followed and implemented
  • IQ, OQ and PQ for the system has been done and system has been found to be fully compliant to these
  • Performance Qualification will be done for each study subsequent to configuration and before the study is moved to live.

Data Security and Integrity

  • The database can be accessed only through the application
  • The application has very strict access controls in place
  • Data extraction has to be done through the application
  • All access keys are encrypted and stored in the database
  • Data transfer from client to server is using secure protocols
  • Data integrity is managed by system design, which does not allow deletion of any data in the system and logs all changes and access

Licensing

Clinion™ is available as an On Demand service (SaaS) and also as an On-premise licensed system.

On Demand

  • Users simply need to sign up and create their account
  • They can login and configure their study and edit checks
  • They can deploy this study to a staging server and subsequently to a live server
  • Data capture can take place. This is the same for an EDC and a CDM Study.
  • Once study is completed they can lock the study and extract the data
  • The data on the server is archived and stored securely with adequate backups as per regulatory requirements.

On Premise:

  • Clinion™ is also licensed as an On Premise system
  • A perpetual license with a fixed set of studies is available for clients
  • The software will be deployed at client server along with validation and training
  • A helpdesk is available to clients requiring help in configuring studies or requiring any other technical help.
  • All upgrades and patches are made freely available to clients as per the support plan.

Clients & Partners

Quad One offers products and services in the Life Sciences area. It offers other clinical software and also offers data management in clinical trials and other clinical trial applications.

Quad One also offers custom solutions and would be able to custom build applications which can manage large amounts of Clinical Trial and medical data.

Quad One is a member of the Society for Clinical Data Management (SCDM) and follows SCDM initiative in Good Clinical Data Management Practices (GCDMP).

Clinion Screenshots

Clinion Brochure

Get in Touch

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