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CISYS ClinApps™

  • CISYS ClinApps™ division is our largest area of concentration. Providing Compliant – Flexible – Secure applications for the BioPharm & CRO community.
  • Our solutions address challenges that are found in Clinical Trials, Clinical Data Management and Post Marketing data collection.
  • Utilizing proven development methodology incorporated with clean graphic user interface – we meet / exceed client expectations.
  • Integrated custom solutions are frequently created to meet the unique demands of various study designs.
Clinical Research
  • Adverse Events Tracking System
  • Enterprise Validation
  • Institutional Review Board
  • Site Management
  • ClinTrain
  • Investigator Mapping
  • Tactical Planning
  • Integrated Applications
  • Validation Compliance
Clinical Data Managemt
  • Document Management System
  • DataConverge
  • Patient Registry
  • Adverse Events Tracking System
  • Validation Compliance
  • Clinical Content Management & Control
Post Marketing Data
  • Patient Registry
  • Management
  • Validation Compliance
  • Integrated Applications
  • Mobile Data Collection
  • Virtual Data Collection

CISYS delivers the extensive expertise and tools needed to meet 21 CFR Part 11, Computer Systems Validation and HIPAA requirements. We help our clients architect, develop and deploy FDA and HIPAA compliant systems by utilizing our comprehensive experience with regulatory requirements, data management and security, and systems development and integration skills.

CISYS has strived to deploy cost effective, integrateable and supportable systems that exceed our client’s needs now and well into the future. The compliant systems we develop or consult on are no different. All of our systems are focused on delivering efficiencies and ROI, allowing our customers to make better business decisions through the meaningful management and analysis of critical business intelligence. Whether it’s electronic submissions, clinical data collection, outcomes analysis, audit trails or security, CISYS is there to guide you through the maze of regulatory hurdles between your product and the successful and profitable delivery to market.

  • Methodology driven project management and software development
  • 21 CFR Part 11, Computer Systems Validation, HIPAA
  • Full CSVlifecycle documentation for existing or planned systems
  • Integration with enterprise systems
  • Extensive QA methodology

System Integration and Support
CISYS builds, integrates and supports many different kinds of systems that conform to your business processes and requirements. We can help you evaluate off-the-shelf systems for use within larger, custom built corporate systems, ensuring the entire enterprise level system is Part 11 compliant. Some types of FDA related systems that we have experience with are as follows:

  • Document management
  • Data collection, capture and transmission
  • Data warehousing
  • Clinical trials management
  • Issue tracking and resolution
  • Audit Management and Reporting