Clinical Trial Management System
Make clinical trials management process a breeze with cloud technologies

CTMS

Clinical Trial Management System

Processing and storage of clinical trials specific data such as sites, investigators and subjects management
  • Feasibility assessment
  • EDC and IWRS integration
  • Investigators invoicing per visit
Modules
CRA Activity Management

CRA Activity Management

  • Separate CRA cabinet
  • Communications management
  • Risk assessment
  • Submissions to regulatory authorities
  • Protocol deviations
  • Vendors
  • Source Data Verification
  • Risk-based monitoring
  • Electronic signature is embedded in monitoring visits reports
Subject Tracking & Invoicing

Subject Tracking & Invoicing

  • Subject data storage and processing
  • Invoice generation on accomplished activities
  • Activity schedule planning
  • Automatic notifications
  • Reports and statistics
  • Full integration with IWRS and EDC systems
Investigator & Site Management

Investigator & Site Management

1. Full integration with Project Catalogue and Business Process Management System

2. Feasibility assessment tool

3. Storage and processing information about:

  • Sites (address, accreditation certificate, site team, structure, clinical trials experience)
  • Investigators (contact information, experience in different trial phases and therapeutic areas)
  • Medical institutions (address, description, equipment, capacity)
  • Ethical committees
  • Laboratories and vendors

CRA Activity Management

  • Separate CRA cabinet
  • Communications management
  • Risk assessment
  • Submissions to regulatory authorities
  • Protocol deviations
  • Vendors
  • Source Data Verification
  • Risk-based monitoring
  • Electronic signature is embedded in monitoring visits reports

Subject Tracking & Invoicing

  • Subject data storage and processing
  • Invoice generation on accomplished activities
  • Activity schedule planning
  • Automatic notifications
  • Reports and statistics
  • Full integration with IWRS and EDC systems

Investigator & Site Management

1. Full integration with Project Catalogue and Business Process Management System

2. Feasibility assessment tool

3. Storage and processing information about:

  • Sites (address, accreditation certificate, site team, structure, clinical trials experience)
  • Investigators (contact information, experience in different trial phases and therapeutic areas)
  • Medical institutions (address, description, equipment, capacity)
  • Ethical committees
  • Laboratories and vendors
 
Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices.
 
Tameo Kobayashi. Chief Innovation Officer, Director, Business Innovation Dept., International Business Development Div., CMIC HOLDINGS Co.,Ltd.
Benefits and features
  • Modularity and individual customization
    CTMS consists of a number of modules, which can be used together, separately or with other modules on our platform. You may choose certain options now and increase your use of CTMS anytime in the future
  • 21 CFR Part 11 Compliance
    Use of Standard Operating Procedures during the entire software development lifecycle and provision of the appropriate quality assurance level, including GxP functions validation to guarantee accuracy, reliability and consistent operational functioning of the system and possibility to reveal invalid or changed electronic records
  • Reliable data protection
    Use of cluster, GFS rotation, tape storage in a bank safe deposit
  • Easy-to-use system
    User-friendly interface, access to the system from any device, quick-responding technical support
  • Free trial period
    We provide sandbox access to our clients to try the system
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